Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Bhanu K Bhakhri

"The Journal of Clinical and Diagnostic Research (JCDR) has been in operation since almost a decade. It has contributed a huge number of peer reviewed articles, across a spectrum of medical disciplines, to the medical literature.
Its wide based indexing and open access publications attracts many authors as well as readers
For authors, the manuscripts can be uploaded online through an easily navigable portal, on other hand, reviewers appreciate the systematic handling of all manuscripts. The way JCDR has emerged as an effective medium for publishing wide array of observations in Indian context, I wish the editorial team success in their endeavour"



Dr Bhanu K Bhakhri
Faculty, Pediatric Medicine
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute, Noida
On Sep 2018




Dr Mohan Z Mani

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Professor & Head,
Department of Dematolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
Knowledge is treasure of a wise man. The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
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Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help ones reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journalsNo manuscriptsNo authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2012 | Month : April | Volume : 6 | Issue : 2 | Page : 220 - 225

Comparative Evaluation of the Efficacy and Side Effects of Imipramine, Sertraline and an Ayurvedic Formulation in Patients of Depression

Jyotsna Bhargava, Zafar Yab Khan

1. Associate Professor, Dept. of Pharmacology, SMS Medical College, Jaipur (Rajasthan), India. 2. Professor and Head, Dept of Pharmacology, Mahatma Gandhi Medical college, Sitapura, Jaipur (Rajasthan), India.

Correspondence Address :
Jyotsna Bhargava
Associate Professor, Dept. of Pharmacology, SMS Medical
College, Jaipur (Rajasthan), India.
Phone: 09829506847
E-mail: drjyotsna2003@yahoo.com

Abstract

Background: Anti-depressant drugs which are used in the Allopathic system of medicine for the treatment of depression have side effects. Studies which have compared the efficacy and the side effects of Allopathic and Ayurvedic drugs in the treatment of depression have not been reported.

Aims: The aim of the present study was to compare the efficacy and the side effects of imipramine and sertraline which are the commonly prescribed drugs in the Allopathic system of medicine for the treatment of depression, with an Ayurvedic formulation.

Settings and Design: This study was an open labeled randomized clinical trial which involved 90 depressive patients who were divided into three groups of 30 each, for the administration of imipramine, sertraline, and an Ayurvedic formulation respectively. HAM-D scoring was done and a side effect checklist was also prepared.

Materials and Methods: The Ayurvedic formulation consisted of aqueous extracts of Brahmi, Shankhpuship, Malkangni and Jatamansi which were mixed in equal proportions (250 mg each). The Ayurvedic formulation was administered at a dose of 1000 mg orally in two divided doses; and imipramine and sertraline were administered at a dose of 150 mg each per day, to separate the groups of patients. The persons who abided by the inclusion and exclusion criteria were selected randomly. The effect of the treatments on the treated patients was repeatedly assessed at a continuous interval of two weeks for three months.

Results: The Ayurvedic formulation had negligible side effects and it was found to be effective at par with imipramine and sertraline at the end of three months.

Conclusions: The Ayurvedic formulation was found to be better as compared to imipramine and sertraline for the treatment of patients with mild to moderate depression, due to its lesser side effects.

Keywords

Depression, Imipramine, Sertraline, Brahmi, Shankhpushpi, Malkangni, Jatamansi, Clinical

INTRODUCTION
Major depression is one of the most common psychiatric disorders. It is a chronic and a recurrent disorder (1). According to the WHO, every year, 5.8% males and 9.5% females experience episodes of depression worldwide (2). By 2020, it would be the second leading cause of disability, second to ischaemic heart disease (3). It would fourth rank among all the medical illnesses in terms of its disabling impact on the world population (4). Depression is common in people in their 20s, 30s, and 40s although depression can occur at any age. People who were born in the later part of the 20th century seemed to have higher rates of depression and suicide than those of the previous generation, in part, because of high substance abuse and the rising demands in the standards of living (5),(6).

At least one in ten outpatients have major depression but most of the cases are unrecognized or inappropriately treated (7). This imposes a large economic burden on the society, it decreases the productivity and the functional decline and it increases the mortality (8). The appropriate therapy improves the daily functioning and the overall health of the patients with depression. Mood disorders are highly relapsing illnesses in many patients and they require long term therapy (9). Allopathic drugs play a major role in satisfying the health care needs of the individuals. There is recurrence and relapse which are clinically relevant issues, mainly due to the side effect profiles which are faced with the allopathic drugs and their drug interactions in co-morbid conditions (10). The choice of anArticleanti-depressant is largely influenced by its side effect profile (11). Although patients respond to the current drug therapy, imipramine or sertraline for the treatment of depression, these leave them with unresolved depression on long term treatment, as was depicted by earlier studies, due to a higher incidence of their side effect profiles (12).

Several drug utilization studies have documented that anti-depressants are usually taken at doses well below those which have been recommended. The possible explanation for the widespread under dosing is that depressed patients who are treated on an outpatient basis need to continue to work and function in the community and they cannot tolerate the adverse reactions that anti-depressants usually produce. With a low dose of anti-depressants, clinicians trade off a slightly reduced chance of improvement for a higher chance of avoiding adverse reactions, may be due to recurrence and relapse. The adverse effects increase significantly with doses (13).

A number of plants have been reported to possess anti-depressant-like activity by pre-clinical and clinical studies. Brahmi (Bcopa monniera) has been reported to possess an anti-depressant-like activity in rats (14) and it is a well established cognitive enhancer (15) in clinical studies. Shankhpushpi (Convolvulus pluricaulis) has been reported to possess an anti-depressant-like activity in mice (16) and in clinical studies (17). Malkangni (Celastrus paniculatus) has been reported to possess an antistress activity in mice (18) and inclinical studies (19). Jatamansi (Nardostachys jatamansi) has been reported to possess an anti-depressant-like activity in mice (20). But a combination of these plants has not been evaluated and compared for its effectiveness and side effects; with the commonly employed allopathic drugs (imipramine and sertarline) for the treatment of patients with depression.

Keeping in view the above facts, the present study was carried out to evaluate the efficacy, the side effect profile and the usefulness of an Ayurvedic formulation which comprised of aqueous extracts of Brahmi, Shankhpushpi, Malkangni and Jatamansi which were mixed in equal proportions (21), and to compare this with the representative drugs like tricyclic anti-depressants and selective serotonin reuptake inhibitor classes of anti-depressants, that is, imipramine and sertraline respectively.

Material and Methods

Drugs
Brahmi, Shankhpushpi, Malkangni and Jatamansi were procured from the Padmnabham Ayurved Hospital and Research Centre, Jaipur (Rajasthan). Imipramine hydrochloride (Sun Pharma) and sertraline hydrochloride (Unichem) were used as the standard anti-depressant drugs.

Recruitment of the Patients
The present study was approved by the ethics committee of SMS Medical College, Jaipur, vide letter number No. 4/MC/EC/JPR/2005. The patients were classified according to their demographic profiles (age and gender, marital status, occupation, education, religion, type of family and domicile). They were put on treatment by any of the three drugs (imipramine, sertraline and the Ayurvedic formulation) after they were diagnosed to have a major depressive disorder and after qualifying for the inclusion and exclusion criteria. They were followed up for a period of three months. The follow up of these patients was done on after every week for the first two weeks and in the 4th, 6th, 8th, 10th and 12th week thereafter. In the follow up period, the patients were re-examined for improvement in their signs and symptoms, as was mentioned in the case report form. The patients did not receive any other drug for the management of depression during the whole study period. Any side effect which was experienced by the patientduring the treatment period was recorded. On the unlikely event of a serious adverse effect, the treatment was stopped and the necessary corrective measures were taken.

The patients were screened for their HAM-D scores and a side effect checklist was filled. The HAM-D scores and the side effects which were presented were recorded on each visit after examining the patient. The patients’ conditions at the end of the treatment were compared to their conditions at the baseline level on the HAM-D score.

Statistical Analysis
The values were expressed as mean ± S.D. The data was analyzed by one-way ANOVA, followed by Dunnett’s post hoc test. A P value of <0.05 was considered as statistically significant.

Preparation of the Extract
The extract was prepared by mixing 1 part of each herb (Brahmi, Shankhpshp, Makangni, Jatamansi) with 8 times distilled water and by keeping it overnight. This mixture was heated till the extract was reduced to 1/8th of its volume. The final extract was filtered through a sieve. The filtrate was dried by using a water bath. The dried extract was formulated into tablets (vatis), each of 125 mg strength.

Study design
This study was conducted on 90 patients with major depression, who scored 25 or more on the HAM-D scale, who were in the age group of 18-60 years, keeping in mind the following inclusion and exclusion criteria.

Inclusion criteria: The patients were entered into the study if the following criteria were met: 1. The subject should be able to comprehend the consent form and he/she should provide a written informed consent prior to commencing any study specific assessments and procedures. 2. Males and females should meet the age criteria at the time of the consent. 3. The patient should be diagnosed as a case of “depression” by a well qualified psychiatrist. 4. The subject must meet the DSM-IV criteria for depression. 5. The subject should have a HAM-D total score of 17 at both the screening and the baseline visits.

Exclusion criteria: The subjects were not enrolled in the study if the following criteria were met: 1. Subjects with a history of manic illness or schizophrenia, any other major psychotic disorders or dementia homicidal or suicidal patients. 2. Anything that suggests unresponsiveness to pharmacotherapy or non-compliance with the protocol (antisocial or borderline personality disorder).

3. The patient does not satisfy the scoring criteria for major depression. 4. The subject’s depression is due to some medication or chronic debilitation illness. (hypothyroidism, Parkinson’s disease, chronic pain) 5. Subjects with a past history of seizure disorder or brain injury (traumatic or disease related), any condition that predisposes to seizures, medications that lower the seizure threshold,; subjects undergoing alcohol withdrawal or a sedative or those who suffer from a cardiac problem, 6. Subjects with disorders that interfere with the action, absorption, distribution and metabolism or excretion of the treatment drug. 7. Any medical condition that interferes with the accurate assessment of the safety or efficacy of the drugs which are under study. 8. A medically significant history of any adverse effects of the drug which was being used or with its closely related compound. 9. Subjects on any other medication that has the potential to interact with the drugs under study e.g. benzodiazepines, other sedatives or hypnotics and other psycho-active medicines, including psychoactive herbal treatment and nutrition supplements. 10. Subjects with any kind of cardiac aliment e.g. coronary artery disease, congestive heart failure, hypertension; chronic alcoholics and patients with a suicidal tendency or substance abuse or dependence, 11. Subjects with a systolic blood pressure of > 150mm of Hg or a diastolic blood pressure of > 95 mm or Hg at either the screening visit or the baseline visit, 12. The subjects should not be participating in any other clinical trial in which they were or would be exposed to an investigational drug or non-investigational drug or device for studies which were related or unrelated to the present illness. 13. The subject is non-compliant with the study visit schedule or with the study procedures e.g. illiteracy, planned vacation, planned hospitalizations during the course of the study, etc. The patients who were randomly assigned to a 12 week trial with the imipramine group received a dose of 75-150 mg/day, those in the sertraline group received a dose of 50-150 mg/day and the third group was the group that were given an Ayurvedic formulation in the dose of 500 mg twice a day.

Results

Demographic Profile
1. The gender and ages of all the groups have been shown in (Table/Fig 1). All the groups included adults who were between 18 to 16-years of age. The different age groups were treated with different treatments (imipramine, sertraline and the Ayurvedic formulation). A total of 30 patients were administered the drug in each group. The mean age of the patients in each of the drug treated groups has been shown in (Table/Fig 2). 2. The marital status of the subjects in each group of the treatment has been depicted, and there was no difference between the three groups (imipramine, sertraline and the Ayurvedic formulation), as regards their marital status (Table/Fig 3). 3. The occupation of all the 30 patients in each treatment group (Imipramine, Sertraline or the Ayurvedic formulation) has been presented in (Table/Fig 4). 4. The educational status of all the 30 subjects for each treatment group (Imipramine, Sertraline or the Ayurvedic formulation) has been presented in (Table/Fig 5). When the educational status of the subjects who were included in the three treatment groups were compared, it was evident from the table that the three groups had a similar distribution pattern; however, there is a tendency among the patients with a higher educational status to take the Ayurvedic treatment. 5. The religion of the patients in the three treated groups (Imipramine, Sertraline or the Ayurvedic formulation) has been presented in (Table/Fig 6). It is clear from the table that the Muslims were not inclined to the Ayurvedic treatment, which can be explained by the fact that the choice of therapy in the Muslim religion is not Ayurveda but Unani (the Unani system of medicine is similar to the Ayurvedic system of medicine). 6. The type of family in the three treated groups (Imipramine, Sertraline or the Ayurvedic formulation) has been presented in (Table/Fig 7). From this table, it is clear that approximately over 60% of the subjects belonged to nuclear families in each treatment group. 7. The distribution according to domicile of all the 30 subjects in each treatment group (Imipramine, Sertraline or the Ayurvedic formulation) has been presented in (Table/Fig 8). Approximately 76.67% of the patients were from urban areas, who were inclined to take the Ayurvedic treatment and 60% of the patients were from the rural areas, who had an inclination towards the allopathic treatment.

Effect of imipramine, sertraline and the Ayurvedic formulation per se on the depression scores of the patients at different visits:
There was a significant progressive decrease in the depression scores from the 3rd visit to the 6th visit for the imipramine treated group and from the 2nd visit to the 6th visit for the sertraline and the Ayurvedic formulation treated groups; indicating the significant anti-depressant property of imipramine, sertraline and the Ayurvedic formulation per se in the patients (Table/Fig 9). The more the ‘q’ value for the Dunnett’s post hoc test was, the higher was the decrease in the depression scores of the patients. At visits 3, 4 and 5, sertaline had the highest ‘q’ value and so it showed the best anti-depressant activity as compared to imipramine and the Ayurvedic formulation. But at visit 6 (after 3 months), the Ayurvedic formulation has the highest ‘q’ value and so it showed the best anti-depressant activity as compared to imipramine and sertraline.

Side effects which were observed for imipramine, sertraline and the Ayurvedic formulation per se in the patients: The most commonly reported adverse effects in the decreasing order of their incidence in the imipramine treated patients were sedation, dry mouth, tachycardia, abdominal discomfort, tremors, sexual dysfunction, weight gain, urinary retention and agitation. The most common adverse effects of sertraline in the descending order of their incidence were nausea, abdominal discomfort, dry mouth, weight gain, sexual dysfunction and tachycardia. The largest difference between imipramine and sertraline in the incidence of their side effects was the incidence of nausea in the sertraline treated patients. The incidence of the adverse events was slightly higher for the imipramine treated subjects.

The Ayurvedic formulation virtually had the least side effect profile in comparison to imipramine and sertraline. Sedation, tremors and abdominal discomfort were much less in the Ayurvedic formulation treated group as compared to the imipramine and the sertarline groups. Other side effects like dry mouth, urinary retention, weight gain, agitation, tachycardia, nausea and asexual dysfunction were not reported with respect to the Ayurvedic formulation (Table/Fig 10).

Discussion

In the present study, imipramine, sertraline and the Ayurvedic formulation produced a significant anti-depressant effect in patients with mild to moderate depression. At the end of three months, the Ayurvedic formulation produced the highest anti-depressant activity as compared to imipramine and sertraline. Further, the Ayurvedic formulation had the least side effects. The depression was diagnosed according to the guidelines which were set by the American Psychiatric Association that followed the DSM-1V criteria (22).

The most common problems of clinical relevance which were encountered by the physicians and the patients, ever since the first anti-depressants came to be known, until the present time, are their side effect profile and their onset of action, apart from the others that are also of importance, namely their efficacy, recurrence,relapse, onset of action, co-morbidity of the mood disorders and other associated medical conditions (23),(24). While analyzing all the associated problems that have to be faced in the course of the treatment with allopathic anti-depressant drugs, alternative systems of medicine need to be explored for a better management of depression.

Imipramine, a representative drug from the tricyclic anti-depressant group and Sertraline, a representative drug from the selective serotonin reuptake inhibitor group were compared with an Ayurvedic preparation (an aqueous extract of four herbal drugs namely Brahmi, Shankhpushpi, Malkangni and Jatamansi which were mixed in equal proportions). In the present study, the onset of action of sertraline and the Ayurvedic formulation was reported at visit 2, but it was reported only at visit 3 in the imipramine treated patients. The anti-depressant effect of the Ayurvedic formulation was the best at the end of three months. Previous studies on herbal drugs also have documented their therapeutic potentials in the treatment of mental disorders (15),(17),(19).

An interesting finding in our study was the side effect profile of the Ayurvedic formulation, which was virtually negligible and its anti-depressant effect was best at the end of three months, which indicated that the Ayurvedic formulation could be a promising drug for mild to moderate depression. However, in acute cases of depression with marked psychomotor retardation or suicidal tendencies, where one has to choose a drug with a rapid onset of action, sertraline, followed by imipramine becomes a better choice (23).

Conclusion

The Ayurvedic formulation which was administered for 3 successive months showed the best anti-depressant effect as compared to the two allopathic drugs, namely, imipramine and sertraline, at the end of three months in patients with mild to moderate depression. The Ayurvedic formulation had negligible side effects. Further studies can be undertaken to evaluate the anti-depressant efficacy of the Ayurvedic formulation in severe cases of depression.

Acknowledgement

Authors are grateful to Dr. Ramesh Kumar and Dr. Pashupati Nath, Padmnabham Ayurved Hospital and Research Cente, Jawahar Nagar Colony, Near Glass Factory and FCI, Tonk Road, Jaipur for their kind help in successfully carrying out this research study.

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DOI and Others

DOI: JCDR/2012/4138:1998

Financial OR OTHER COMPETING INTERESTS:
None.


Date Of Submission: Sep 20, 2011
Date Of Peer Review: Dec 20, 2011
Date Of Acceptance: Feb 21, 2012
Date Of Publishing: Apr 15, 2012

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