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

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Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dermatolgy,
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.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



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 one’s 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 journals–No manuscripts–No 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

Research Protocol
Year : 2025 | Month : March | Volume : 19 | Issue : 3 | Page : FK01 - FK04 Full Version

Pharmaceutico-analytical Study of Dhananjayadi Vati and Assessment of its Antihistaminic Activity: A Research Protocol


Published: March 1, 2025 | DOI: https://doi.org/10.7860/JCDR/2025/73505.20732
Puja Maldhure, Anita Santoshrao Wanjari, Anjali S Katore, Kirti Naharwal

1. Postgraduate Scholar, Department of Rasashastra and Bhaishajya Kalpana, Mahatma Gandhi Ayurved College Hospital Research Centre, Salod, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India. 2. Professor and Head, Department of Rasashastra and Bhaishajya Kalpana, Mahatma Gandhi Ayurved College Hospital Research Centre, Salod, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India. 3. Assistant Professor, Department of Rasashastra and Bhaishajya Kalpana, Mahatma Gandhi Ayurved College Hospital Research Centre, Salod, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India. 4. Postgraduate Scholar, Department of Rasashastra and Bhaishajya Kalpana, Mahatma Gandhi Ayurved College Hospital Research Centre, Salod, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India.

Correspondence Address :
Dr. Anita Santoshrao Wanjari,
Professor and Head, Department of Rasashastra and Bhaishajya Kalpana, Datta Meghe Institute of Higher Education and Research, Wardha-442001, Maharashtra, India.
E-mail: anitawanjari7@gmail.com

Abstract

Introduction: Histamine is the local hormone synthesised by mast cells in the tissue and basophils in the blood. Histamine and its Receptors (H1R-H4R) have a substantial impact on the onset of many allergic diseases. Allergic diseases, including asthma, pruritus, atopic dermatitis and allergic rhinitis, result from the complex interaction of inflammatory cells like basophils, mast cells, lymphocytes and dendritic cells responding to various environmental and allergic stimuli.

Need of the study: An antihistamine is a medication that works against histamines to relieve allergy symptoms. These medications help to address conditions triggered by histamine in the body. However, some non steroidal antihistaminic drugs are proven to be quick-acting but are associated with potential side-effects, such as organ damage. In Ayurveda, several medicinal preparations have been mentioned to combat the allergic condition and the Dhananjayadi tablet (Vati) might also be significantly effective in allergic conditions.

Aim: Pharmaceutico-analytical evaluation of Dhananjayadi Vati and assessment of its antihistaminic activity.

Materials and Methods: An in-vitro study will be conducted in the Department of Dravyaguna at Mahatma Gandhi Ayurved College Hospital Research Centre, Salod (H) Wardha, Maharashtra, India from August 2024 to March 2025. All herbal drugs will be collected, verified and primarily authenticated by the Department of Dravyaguna and will be prepared as per the references. Organoleptic parameters (touch, appearance, taste, odour) and physicochemical parameters (hardness, pH value, uniformity of weight, loss of drying at 105°C, total ash, acid-insoluble ash, water-soluble extractive values, alcohol-soluble extractive values, disintegration time, friability and High-Performance Thin-Layer Chromatography (HPTLC) of the drug) will be evaluated. The antihistaminic action of Dhananjayadi tablet (Vati) will be evaluated in-vitro while assessing the proportion of contraction of goat tracheal tissue. A paired t-test will be conducted for pre- and postintervention evaluation and a p-value <0.001 will be considered statistically significant.

Keywords

Antiallergic, Histamine, In-vitro study, Kasa, Physico-chemical

Ayurveda is India’s oldest and most well-known medical system. It is an ancient method with a history of more than 5,000 years and can successfully treat a wide range of illnesses (1). Ayurveda, as a whole, represents the “Science of Life.” It is a qualitative, all-encompassing approach to wellbeing and longevity (2).

Ayurvedic pharmaceutics (Bhaishajya Kalpana) is a science that involves applying various procedures (Sanskar) over medicine (Bheshaja). Medicine (Bheshaja or Bhaishajya) is one among the four pillars of treatment (Chikitsa Chatushpada) that eliminates the dread of disease or restores a person’s health by stabilising the dosha and without which disease suppression is impossible. The term Kalpana refers to Yojana (Planning), which involves utilising various substances. Therefore, Kalpana is the process or modification through which a substance is converted into a medicinal form (3). The medications require processing, which can be accomplished using the standard five pharmaceutical procedures (Panchavidh Kashaya Kalpana), namely Juice (Swaras), Paste (Kalka), Decoction (Kwath), Cold infusion (Hima) and Hot infusion (Phant) (4).

The pharmaceuticals must undergo processing before they can be used, which can be achieved using pharmaceutical techniques. Many other formulations have been developed to improve taste, extend shelf life, reduce dosage, ensure rapid effectiveness and make handling and dispensing easier (5). Researchers have adapted the formulas to meet current requirements without compromising their effectiveness or the aforementioned advantages, but it is crucial to demonstrate their usefulness in modern times (6).

‘Vati Kalpana’ is a significant secondary preparation (Anukalpana) in Ayurveda pharmaceutics. A tablet (Vati) is made from powdered medication, which is then mixed with liquid and shaped into a circular mass. This is the most widely produced and sold dosage form in the pharmaceutical world across all medication systems. It is prepared from herbal, herbs-mineral, or mineral drugs. The tablet (Vati Kalpana) is a commonly used form of medication due to its benefits, such as easy swallowing without irritation, ease of transportation and accurate dosing [7,8].

The word processing (Sanskar) is defined as “Samskaro hi Gunaantradhyanam,” which means that the improvement in inherent characteristics of a drug is achieved by integrating specific qualities, resulting in a qualitative enhancement of its natural properties. One of the formulations listed in Yogaratnakar in the Kasa Rogadhikara is the Dhananjayadi tablet (Vati). This formulation contains Terminalia arjuna Roxb. (Arjuna), Cinnamomum zeylanicum Breyn. (Twak), Elettaria cardamomum Maton (Ela), Cinnamomum tamala Nees (Patra), Piper longum Linn. (Pippalimoola), Zingiber officinalis (Sunthi), Piper nigrum Linn. (Maricha) and Piper longum Linn. (Pippali) and is used to cure Kasa (9).

Cough (Kasa) is one of the pathological conditions covered in Ayurvedic literature. The Kapha and Vata doshas are the two main doshas that cause the illness known as cough (Kasa). Increased Kapha forms a sort of mucus coating in the throat (Upalepa) in the respiratory system (Pranavaha Srotas), obstructing the normal pathway of air (Vayu) and leading to its vitiation. Cough (Kasa) may develop as an independent disease, with symptoms associated with other diseases and complications (Upadrava) of the disease (10). Early intervention is necessary to treat cough (Kasa); untreated cough (Kasa) can leads to dyspnoea (Shwas), emaciation (Kshaya) and sunken voice (Swarasada). Cough is one of the prevalent health issues, being the foremost commonly encountered symptom for which patients seeks medical care (11). It can happen due to secretions, irritants, foreign particles and microorganisms. Coughing can arise from a range of reasons, which encompass respiratory tract infections such as pneumonia, acute bronchitis and common cold, as well as lifestyle factors like smoking and health conditions like asthma and tuberculosis.

Antihistamines are commonly used to relieve allergy symptoms and are effective in managing conditions triggered by excess histamine, which is a compound produced by the body’s immune system. However, some non-steroidal antihistamines have been shown to act quickly but may cause adverse effects, such as organ damage (12). Dhananjayadi Vati is a formulation mentioned in the Yogaratnakara text under Kasa Chikitsa. It consists of eight ingredients in equal proportions, with Ardraka Swarasa used as the Bhavana Dravya and it is prepared using the Niragni method (13). There is a continuous need to explore and expand therapeutic options beyond the current ones. The standard operating procedures for preparing Dhananjayadi tablets (Vati), along with their quality assurance parameters and pharmacodynamics, have not yet been established. Therefore, this study aims to conduct a pharmaceutical-analytical investigation of Dhananjayadi Vati and assess its antihistamine activity.

Primary objective:

1. To prepare Dhananjayadi tablet (Vati) according to classical reference and to develop a standard operating procedure for manufacturing Dhananjayadi Vati.

2. To analyse the Dhananjayadi tablet (Vati) for quality assurance.

Secondary objective:

1. In-vitro assessment of the antihistaminic activity of the Dhananjayadi tablet (Vati).

Null hypothesis: The Dhanjayadi tablet (Vati) will not demonstrate significant antihistaminic activity.

Alternate hypothesis: Dhanjayadi tablet (Vati) will demonstrate a significant antihistaminic activity.

Review Of Literature

Vati Kalpana plays a crucial role in Ayurvedic pharmaceutics due to its various advantages. Dhananjayadi Vati is one such formulation referenced in the Kasa Chikitsa Adhyaya of Yogaratnakara (7),(8).

In a study by Mudukannanavara S et al., the traditional Dhananjayadi Vati formulation was modified into Dhananjayadi Vati lozenges for added convenience. The analysis of Dhananjayadi Vati and its lozenges showed that both met standards, each having less than 1.0% w/w of certain components, indicating they can handle stress well. However, the weight consistency was poor. Dhananjayadi Vati contained 8.39% w/w total ash, compared to 0.39% w/w in the lozenges, meaning it has more inorganic compounds. Dhananjayadi Vati is made by mixing powdered ingredients with ginger juice and drying them, while lozenges combine caramel syrup with decoction and powders. The acid-insoluble ash was low (0.07% for Vati and 0% for lozenges), indicating few indigestible substances. Both had a pH of 6.0, showing mild acidity. The water-soluble extract was 64.5% for Vati and 92.5% for lozenges, suggesting more active ingredients in the lozenges. The alcohol-soluble extracts were 5.46% in Vati and 2.28% in lozenges, indicating more phytochemicals in the Vati. HPTLC showed eight spots for Vati and three for lozenges at 254 nm, with potential ellagic acid present. Microbial contamination was “too numerous to count” for Vati and 50 for lozenges, which suggests better safety for the lozenges due to their preparation process. Phytochemical screening found alkaloids, resin, carbohydrates and tannins in both, with steroids and coumarins in Vati and flavonoids and terpenoids in lozenges. This analysis highlights the differences and potential benefits of each formulation. Since there are no established standards for Dhananjayadi Vati and its lozenges, the findings from this study serve as a reference for future evaluation of the product (13).

Material and Methods

An in-vitro study will be conducted in the Department of Dravyaguna at Mahatma Gandhi Ayurved College Hospital Research Centre, Salod (H), Wardha, Maharashtra, India from August 2024 to March 2025. IEC no. MGACHRC/IEC/July-2022/559. The drug will be procured from Dattatraya Ayurveda Rasashala and Herbal Garden at MGACH and RC Salod (H), Wardha. Standardisation, authentication and verification of drugs will be done by taxonomists.

Drug Review

Dhananjayadi Vati contains Arjuna tvaka, Tvak, Ela, Patra, Pippali, Sunthi, Maricha and Pippalimoola, as shown in (Table/Fig 1) (14),(15),(16),(17),(18),(19).

Preparation of Dhananjayadi Tablet (Vati): Raw materials will be procured and authenticated according to Active Pharmaceutical Ingredient (API) standards. Each ingredient will then pulverised individually. The drugs are sieved through a mesh of size number 80, individually. The fine powders of drugs are taken in mortar and pestle (Khalva yantra). Bhavana will be given with ginger juice (Ardraka Swarasa) for seven days for three hours. Then, tablets of a specific size (Vati) are prepared (Table/Fig 2) (3).

Primary Outcomes

Standardisation Parameters:

i) Analytical parameters of the Dhananjayadi Tablet (Vati):

A. Organoleptic characters (20):

1. Touch

2. Appearance

3. Taste

4. Odour

B. Physicochemical parameters:

1. pHvalue: A digital pH meter with a combined electrode will be used to measure pH. Before starting the experiment, the instrument will be calibrated using buffer solutions with pH values of 4.0, 7.0 and 9.20 to ensure its accuracy (21).

2. Hardness: Hardness plays an important role in the quality control of tablets, as the compression process influences all aspects of tablet performance, including disintegration, dissolution and stability. It also reflects the bonding strength, internal integrity and brittleness of the tablets. Ensuring that tablets remain intact during transportation and handling until they reach the consumer is essential. The hardness of the drug will be measured using a Monsanto tablet hardness tester (22).

3. Uniformity of weight: To assess drug content uniformity, half-tablets will be compared to one-half of the mean drug content found in the entire sample. To evaluate weight uniformity, the weights of half-tablets will be compared to one-half of the sample’s mean weight for whole tablets using a Mettler balance (23).

4. Loss of drying at 105°C: A 10-gram sample of the compound will be evenly distributed in a shallow petri dish. The dish will then be subjected to controlled heating at 105°C, followed by cooling in a desiccator before weighing. This process will be repeated several times until two consecutive weight measurements are consistent. The percentage of weight loss will then be calculated based on the initial weight (24).

5. Total ash: Two grams of each ash sample will be accurately weighed and placed into silica crucibles. The samples will be evenly distributed across the bottoms of the crucibles, then incinerated, allowed to cool and weighed. The total ash value is determined by subtracting the weight of the empty crucible from the weight of the crucible with the incinerated sample (23),(24).

6. Acid insoluble ash: The residues from the total ash determination will be boiled in hydrochloric acid. After boiling, the insoluble parts will be rinsed with hot water, placed in a crucible, dried and then weighed. The difference in weight between the crucible containing the incinerated sample and the empty crucible provides the measurement for acid-insoluble ash (24),(25).

7. Water soluble extractive values: A conical flask with a glass stopper will be used to mix 5 g of the drug with 100 mL of distilled water and alcohol. After six hours of gentle shaking at regular intervals, the mixture will be left to stand undisturbed for 18 hours. After filtration, 25 mL of the solution will be evaporated using a water bath. The residual residue will be dried at 105°C for six hours, cooled in desiccator for 30 minutes and promptly weighed. The percentage of water-soluble materials will be estimated using the weight of the air-dried medication (22).

8. Alcohol soluble extractive values: The proportion of alcohol-soluble matter will be calculated using the same approach as for water extractive values, but using alcohol instead of water (22).

9. Disintegration time: Disintegration time is a crucial parameter that evaluates the ability of dosage forms, such as tablets, capsules, boluses, pessaries and suppositories, to break down within a specified timeframe when immersed in a liquid medium under controlled experimental conditions. This metric serves as an indicator of the drug’s quality and the characteristics of the binding agent will be used (25).

10. Friability: To analyse tablet friability, standard pharmacopeial procedures require a collection of identical tablets from the same batch. For a single examination, at least 6.5 grams of tablets are required. The test involves dropping the tablets 100 times from an established height while the friability apparatus is in motion. After the process, the tablets are collected, washed and weighed to determine the overall weight reduction. A weight loss of less than 1% is considered acceptable for proven compressed and uncoated tablet formulations (25).

11. HPTLC: HPTLC plays a crucial role in detecting adulterants and evaluating drug quality. This method enables the separation of different chemical components, allowing for the determination of Rf values after spot detection, which is essential for verifying the drug’s identity, purity and potency (22).

Secondary Outcome

The trachea of a newly slaughtered goat will be obtained from the slaughterhouse and promptly placed in a thermostat flask that holds a chilled Krebs-Hansleit solution at 4°C until it is needed the following day.

Isolated goat tracheal chain preparation: Isolated adult goat tracheal tissue will be collected immediately after the goats are slaughtered. The trachea will be segmented into separate rings and then linked together sequentially to create a chain. The trachea will be placed in a bath containing Kreb’s solution with the following components: CaCl2(0.28), KCl (0.35), NaCl (6.9), NaHCO3(2.1), MgSO4(0.28), KH2PO4(0.16) and glucose (2.0) g/L at a temperature of 37±0.5°C. One extremity of the tracheal chain will be connected to an S-shaped aerator tube, while the other end will be linked to an isotonic frontal writing lever connected to a magnified smoked drum (with a magnification of 10-12 times). The tissue will be given 45 minutes under a 400 mg load of Dhananjayadi tablet (Vati) before proceeding. By maintaining a 15-minute time cycle, a dosage-response curve for histamine will be measured. The Dhananjayadi tablet (Vati) will be placed in the appropriate reservoir after getting a dosage-response curve of histamine on the trachea and repeated doses of histamine will be supplied.

In-vitro/Tissue Model: The tracheal chain from the goat trachea is suitable for screening the activity of a drug on respiratory smooth muscles. To examine the contractile and dilator responses to both agonists and antagonists, the contraction of tracheal or bronchial smooth muscle in-vitro will be employed (26). The tracheal muscle in goats contains H1, M3 and B2 receptors. The bronchial smooth muscle contracts in response to stimulation of H1 receptors (27). The dose-response curve for histamine, both in the absence and presence of the Dhanjayadi tablet (Vati), will be recorded using a graph that shows the percentage of maximum contractile response on the ordinate and the negative logarithm of histamine’s molar concentration on the abscissa [28,29].

Statistical Analysis

The IBM Statistical Package for the Social Sciences (SPSS) statistics software (version 29.0) for the statistical analysis will be used. A paired t-test will be applied for pre- and postintervention analysis and a p-value <0.05 will be considered statistically significant.

Reporting guidelines: Checklist for Reporting in-vitro Studies (CRIS) Guidelines checklist for pharmaceutico-analytical study of Dhananjayadi Vati and assessment for its antihistaminic activity-study protocol checklist.

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DOI and Others

DOI: 10.7860/JCDR/2025/73505.20732

Date of Submission: Jun 12, 2024
Date of Peer Review: Jul 25, 2024
Date of Acceptance: Nov 23, 2024
Date of Publishing: Mar 01, 2025

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? No
• For any images presented appropriate consent has been obtained from the subjects. No

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Jun 13, 2024
• Manual Googling: Nov 18, 2024
• iThenticate Software: Nov 21, 2024 (8%)

ETYMOLOGY: Author Origin

EMENDATIONS: 7

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