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

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On Sep 2018




Prof. Somashekhar Nimbalkar

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Prof. Somashekhar Nimbalkar
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Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
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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."



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Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
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Professor and Head
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Saraswati Dental College
Lucknow
On Sep 2018




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Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




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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

Original article / research
Year : 2022 | Month : December | Volume : 16 | Issue : 12 | Page : KC01 - KC05 Full Version

Prescription Pattern and Cost Analysis of Nutraceuticals among Type 2 Diabetes Mellitus Patients: A Cross-sectional Study


Published: December 1, 2022 | DOI: https://doi.org/10.7860/JCDR/2022/59366.17366
Ansaf Hassan Mohammed, Adithi Kellarai, Uday Venkat Mateti, Kala Bahadur Rawal, Barma Naga Raju, Shraddha Shetty, Jagadeesan Moorthy

1. Student, Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences (NGSMIPS), Nitte (Deemed to be University), Mangaluru, Karnataka, India. 2. Associate Professor, Department of General Medicine, KS Hegde Medical Academy, Nitte (Deemed to be University), Mangaluru, Karnataka, India. 3. Assistant Professor, Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences (NGSMIPS), Nitte (Deemed to be University), Mangaluru, Karnataka, India. 4. PhD Research Scholar, Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences (NGSMIPS), Nitte (Deemed to be University), Mangaluru, Karnataka, India. 5. PhD Research Scholar, Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences (NGSMIPS), Nitte (Deemed to be University), Mangaluru, Karnataka, India. 6. Lecturer, Department of Biostatistics, Justice KS Hegde Medical Academy, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India. 7. Assistant Professo

Correspondence Address :
Dr. Uday Venkat Mateti,
Assistant Professor, Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences (NGSMIPS), Nitte (Deemed to be University), Mangaluru, Karnataka, India.
E-mail: udayvenkatmateti@gmail.com

Abstract

Introduction: Type 2 Diabetes Mellitus (T2DM) is a disorder related to the relative lack of insulin secretion leading to abnormal metabolism. In addition to insulin, various micronutrients takes part in the metabolic processes. The imbalance between these vital micronutrients might be one reason for the progression of chronic diseases. There is a need to understand the utilisation pattern of these nutraceuticals in treating chronic conditions like DM.

Aim: To study the prescribing patterns of various types of nutraceuticals and the cost of nutraceuticals per prescription in T2DM patients.

Materials and Methods: This cross-sectional study was conducted in a tertiary care teaching hospital of Dakshin Karnataka, India, from September 2021 to April 2022. Total 150 T2DM patients, who were prescribed atleast one nutraceutical, were included in the study. Collected data was assessed by descriptive analysis (quantitative data; age, height, weight, Body Mass Index (BMI), number of drug prescribed, number of prescriptions, cost of nutraceuticals) whereas qualitative data (gender, social classes, qualification, occupation, domiciliary status, marital status, duration of diseases, family history, social history, personal history) was documented using frequency/percentage.

Results: Out of total 150 subjects, 92 (61.33%) were males, and 58 (38.67%) were females. At the same time, the mean age of the patients was found to be 58.1 years. Among all the prescribed nutraceuticals, vitamins were found to be the most frequently prescribed 97 (64.66%), followed by proteins 45 (30%) and vitamins+minerals 42 (28%). The average number of nutraceuticals per prescription was 1.57±0.76. The average cost of nutraceuticals was 440.55 (Indian rupee) INR per prescription.

Conclusion: The most commonly prescribed nutraceuticals were vitamins in 97 (64.66%) patients. The average additional cost for the nutraceuticals was found to be 440.55 INR.

Keywords

Dietary supplements, Drug utilisation, Economic burden, Nutrients

Diabetes Mellitus (DM) is a chronic metabolic disorder characterised by elevated blood glucose levels (1). T2DM is the condition in which sufficient amount of insulin may be produced by the pancreas but there could be the resistance in the receptors site that will uptake it (2),(3). The human body’s metabolic process is regulated by insulin and other micronutrients. The deficiency of mineral and trace elements may play a vital role in the pathophysiology and progression of metabolic diseases, including diabetes mellitus (4), and finally, benefits in dropping the glycated haemoglobin (1). The term ‘nutraceuticals’ has been defined as any substance that may be considered a food or a part of food and provides medical and health benefits, including preventing and treating disease (5). Nutraceuticals are dietary supplements that balance energy, improve mental concentration, and prevent nutritional deficiencies (5). In today’s health-conscious culture, nutraceuticals are steadily becoming an essential part of the prescription, especially in chronic diseases; these agents widely gain importance for annexation in the diet. Patients’ attitudes towards the consumption of nutraceuticals are due to increased risks of various lifestyle diseases. Nutraceuticals established the role of improving physical and mental well-being. Nutraceuticals include vitamins, herbal products, minerals, metabolites, and functional foods like bran, oats, and antioxidants (6),(7). The poor clinical outcomes and long-term complications of diabetes can be due to the poor balance between the free radicals generated and their scavenging by the physiological process of the human body. Thus, the micronutrients might have a crucial role in preventing complications of chronic diseases and arresting the disease progression (5),(7). Nutraceuticals will play a vital therapeutic function, and their effectiveness will estimate their success with minimum or no adverse effects (8). According to the World Health Organisation (WHO), 50% of hospitalised patients have malnutrition, increasing morbidity and death risk (9). Prescription pattern study insights into the trends of pharmaceutical products prescribed by the physician. Analysis of utilisation patterns may help identify commonly prescribed drugs for managing particular conditions (10). Thus, there is a need to understand the utilisation pattern of these nutraceuticals in treating chronic conditions like DM. Rajasekaran A et al., in a review, found that using nutraceuticals has benefited cardiovascular diseases, obesity, DM, malignancies, osteoporosis, and neurological disorders. Nutraceuticals play an essential role in several biological progressions and have protective action against various illnesses (11). Nutraceuticals are one of the majorly prescribed classes of drugs for treating chronic diseases (12).

Till date there are scarce of data from Karnataka (Southern part of India) that reports mainly on prescription as well as cost of nutraceuticals among diabetic patients. Thus, there is a need to understand the prescription pattern and cost of nutraceuticals per prescription among diabetic patients. Hence, present study was conducted to assess the prescription pattern and cost of nutraceuticals among T2DM patients.

Material and Methods

This cross-sectional study was conducted on Inpatient and Outpatients Department of General Medicine, Justice K.S Hegde Charitable Hospital, Deralakatte, Mangalore, Karnataka, India for a period of eight months, from September 2021 to April 2022. The study was approved by Institutional Ethical Committee (IEC) [REF. NO: NGSMIPS/IEC/12/2021], Clinical Trials Registry-India approval: CTRI/2021/09/036684. The written informed consent was taken from the patients or their legal representative.

Inclusion criteria: Diagnosed cases with T2DM, aged above 18 years, who were prescribed atleast one nutraceutical in the outpatient and inpatient Department of General Medicine were included in the study.

Exclusion criteria: The pregnant mothers with gestational diabetes, Type 1 DM patients, patients who were unwilling to participate in the study, and with severe psychological disorders were excluded .

Sample size calculation: The sample size was calculated by using nMaster software 2.0, by using the following formula;


p=proportion, q=1-p, d=precision, z=1.96 (at α=5% level of sigma), n=sample size

The expected proportion of diabetes mellitus=0.11 (from MRD record of K.S Hegde Hospital), Expected precision=5%, At 95% confidence level (3), and the obtained sample size was 150.

Study Procedure

Data collection: The patients’ data collection form was designed as per the study’s needs. All relevant details were recorded, including patient socio-demographic parameters such as age, gender, weight, height, BMI (13), educational status, employment status, domiciliary status, co-morbid conditions, and social habits. Information regarding the antidiabetic drugs and nutraceuticals prescribed among the patients, including their dose, dosage form, frequency, route of administration, and duration, were recorded. The cost of nutraceuticals per prescription among diabetic patients was analysed considering parameters like brands with the generic name, frequency, and duration of treatment were collected from patient records, pharmacy bills, and interviewing the patients or patient parties.

Cost analysis of different types of nutraceutical drugs: The cost was analysed considering parameters like brands with each generic name used, collected from the patient records, medical invoice, hospital accounts section, and other relevant sources. Percentage price analysis was calculated for different nutraceuticals used in T2DM treatment by using the mean and standard deviation.

Statistical Analysis

The collected data was assessed by descriptive analysis whereas qualitative data was expressed into frequency/ percentage using the Statistical Package for the Social Sciences (SPSS) version 20.

Results

Socio-demographic Distribution

A total of 150 patients were prescribed nutraceuticals. Out of them 92 (61.33%) were males and 58 (38.67%) were females. The 71 (47.33) patients belonged to the age group of 46-60 years old, and around one-third of the overall study patients were overweight. Only 36 (24.00%) of the enrolled patients had secondary-level educational degree qualifications, and 85 (56.67%) patients had low socio-economic status. The minimum duration of patients who had diabetes was found to be one year, the maximum was ≥10 years, and the median of 5 years. Around 121 (80.67%) of the patients had co-morbidities; out of them, hypertension was the most common 73 (48.67%) patients. The 144 (96.00%) of the study population were found to take the mixed diet category (Table/Fig 1).

Out of 150 prescriptions, the most frequently prescribed antihypoglycaemic was Human insulin monotherapy for 53 (35.33%) patients, followed by Metformin for 39 (26.00%) patients. Empagliflozin and Dapagliflozin were found to be prescribed least frequently in 1 (0.66%) patient. Whereas around 60 (40.00%) of patients were prescribed the fixed-dose combination of antihypoglycaemic agents, among them, the most commonly prescribed were 33 (22.00%) metformin+glimepiride followed by the three drugs fixed-dose combinations 9 (6.00%) with metformin+glimepiride+voglibose (Table/Fig 2).

Out of 150 antihyperglycaemic agents, the prescription majority were prescribed one drug for 85 (56.67%) patients, followed by two drugs for 47 (31.33%) patients and three drugs for 16 (10.66%) patients. Whereas, from the total of 150 prescriptions of nutraceuticals, the majority 85 (56.67%) patients were prescribed one drug, followed by two drugs for 50 (33.33%) patients and three drugs for 10 (6.67%) patients. The mean number of nutraceuticals drugs per prescription was found to be 1.57±0.76 (Table/Fig 3).

Among the enrolled patients, the most commonly prescribed monotherapy nutraceutical were vitamins for 97 (64.66%) patients, followed by proteins for 45 (30.00%) patients. At the same time, minerals were prescribed to the least number of patients 2 (1.33%). Whereas in the case of the fixed-dose combination of nutraceuticals, the majority of the patients were prescribed vitamin+minerals for 42 (28.00%) patients, followed by vitamins+minerals+herbs for 9 (6%) patients. Whereas vitamins+minerals+proteins 1 (0.66%) and vitamins+probiotics 1 (0.66%) were prescribed to the least number of patients (Table/Fig 4).

The duration of a nutraceutical prescription ranged from 7-30 days. The majority, 170 (76.57%) of the nutraceuticals were prescribed for 30 days, followed by 14 days duration for 37 (16.67%), and seven days duration for 15 (6.76%) nutraceuticals (Table/Fig 4).

The minimum cost per nutraceutical was found to be 35 INR and maximum was 1363 INR, and the average cost per prescription was 440.55 INR. Enzymes were comparatively expensive 504.2±420.65 INR, followed by proteins 426.63±95.79 INR, whereas vitamins and probiotics were the least cost 87±87 INR (Table/Fig 5).

Discussion

The combination of antidiabetics with nutraceuticals has shown a significant role in reducing the Glycated Haemoglobin (HbA1c), Fasting Blood Sugar (FBS), and Post Postprandial Blood Sugar (PPBS) compared to placebo (1). Nutraceuticals are being increasingly perceived as beneficial to health and are being continuously used to treat various diseases. The safe and effective utilisation of nutraceuticals can help improve disease treatments, significantly hasten the prognosis of the patients condition, and mitigate the complications (4),(6). Research showed that the combination of nutraceuticals had a beneficial effect on insulin resistance associated with metabolic syndrome (14).

In present study, males patients consumed more nutraceuticals (61.33%) when compared to females (38.67%) which was in contrast to the studies conducted by Kulkarni M et al., which suggest that majority were females (51.92%) (15). In this study, the majority of the patients were from the age group of 46-60 years (47.33%), which was in contrast to the study regulated by Dada AO et al., which showed that the majority of the patients were above 60 years (53.6%). The results of present study suggest that the risk of T2DM increases after the age of 40 years (3). From present study, it can be seen that newly diagnosed, i.e., less than one-year diabetic patients were higher (24%) which was similar to the findings of the research conducted by Pushpa VH et al., in their study (56%) of the patients showed less than five years of duration of diabetes which was deviated from present study results of it could be due to they had included geriatric diabetic patients. In contrast, present study has included both adults and geriatric patients. Hence it can be seen that as age advances, the incidence of diabetes also increases (16).

In present study, authors have found that 35.33% of the patients were overweight, which was similar to the study performed by Dada AO et al., (3) which states that the majority of the patients had BMI in the range of 25-29.9 kg/m2 (36.2%) suggesting that overweight is one of the significant risk factors for T2DM. In this study, the average age was found to be (58.1) years, where the co-morbidities (cardiovascular disorders, obesity, weight loss, constipation, diarrhoea, bone, and joint disorders) and complications (macrovascular and microvascular) significantly increase with age; additionally, contributing factors lifestyles and socio-behavioural activities, which are common risk factors for the complication and progression of diseases in India, which is supported by the review conducted by the Tamura Y et al., (7) around one third of our total study population found to have social habits of either smoking or consumption of alcohol or both. Hypertension was the most common co-morbidity (48.67) associated with T2DM among the patients in present study. This was similar to the study conducted by Das AK et al., (17). This suggests that among patients with diabetes, cardiovascular (macrovascular) complications pose a significant threat.

In present study, authors have observed the following microvascular complications associated with patients diabetic retinopathy (5), diabetic nephropathy (5), diabetic foot ulcer (5), and diabetic neuropathy (3). This evidence shows similar to the study performed by Jyothi PD et al., (18) it was found that diabetic neuropathy (16 patients) followed by diabetic foot ulcer (15 patients), hypoglycemic episodes (7 patients), and diabetic nephropathy (5 patients) were the most common complications among the patients with T2DM. Among the 150 prescriptions of antidiabetics, in this study, authors observed that injectable dosage forms of antidiabetics were high in patients. In contrast, the oral dosage form of the antidiabetic was greater in the outpatients, and the reason could be that outpatients are more stable and can be managed with the oral. In contrast, the inpatients had uncontrollable blood sugar levels or severe conditions, so they needed to be managed with injectable antidiabetic therapy. The most commonly prescribed injectable was human insulin (35.33%). However, the results of the studies conducted by Acharya KG et al., (19) and Anila AB et al., (5) showed that most patients received tablet metformin. This deviation may be because present study has enrolled both in and outpatients.

Among the total prescription, authors have analysed that frequently used oral antidiabetics drug was beguanides metformin (26%) followed by the sulfonylurea (glimepiride, gliclazide, glipizide (20%)). Among the fixed-dose combinations therapy, the most commonly prescribed drugs were metformin+glimepiride (22%) which was in agreement with the study performed by Dada AO et al., (3) which states that metformin monotherapy and its fixed-dose combinations were most frequently prescribed medication (32.8%). They suggested that combining biguanides and sulfonylureas was the most commonly effective therapy. Most of the patients in present study were prescribed one antidiabetic drug (56.67%), which was in agreement with the study conducted by Abired A and Atia A, where most of the patients were prescribed with one anti-diabetic drug (50%) (20).

Nutraceuticals are defined as dietary supplements that increase energy, improve mental concentration, and prevent nutritional deficiencies (21). Now-a-days, the main reason for the increased use of nutraceuticals can be attributed to the swift urbanisation, increased prevalence of lifestyle disorders, and people knowingly taking preventive healthcare measures in the form of dietary supplements (21). Vitamins, including fat-soluble and water-soluble, are vital for various physiological functions. Minerals are necessary for properly maintaining bones, heart muscles, and brain, followed by proteins for synthesising various hormones and enzymes. Enzymes are proteins that help speed up chemical reactions in the body. Probiotics help digestion, nutrient absorption, maintain gut health, and contribute to immune function. Although fibres usually maintain normal bowel health and cholesterol levels, the antioxidants are required to normalise the body’s free radicals Nimesh S and Nimesh VD, (22).

In present study, it was found that vitamins (64.66%) were the most prescribed nutraceuticals. This result agrees with the study performed by Shrestha R et al., (23) where vitamins (40.7%) were the most commonly prescribed nutraceuticals among the patients. The most commonly prescribed fixed-dose combination nutraceutical in present study was found to be vitamins+minerals (28%), followed by vitamins+minerals+herbs (6%). A similar result was found in the study performed by Anila AB et al., where most prescriptions (72.17%) contained water-soluble vitamins+minerals (5).

Present study found the average number of nutraceuticals prescribed per prescription was 1.57±0.76. The minimum number of nutraceuticals per prescription has one drug, and the maximum number of nutraceuticals per prescription has four drugs. This was similar to the result of the study conducted by Shrestha R et al., which shows that the average number of nutraceuticals per prescription was 1.52 (23). In present study, the duration of nutraceutical prescription was mainly from 7 days to 30 days, the maximum days (30 days) of nutraceutical prescription were vitamin (56.66%) followed by protein (24.66%) and vitamin+mineral (24%). The least duration of nutraceutical prescription was found for an enzyme (2%) among patients for seven days, which was parallel with the study result of Anila AB et al., where the duration of vitamins prescription was for 30 days, but diverged in the case of the prescription duration of vitamins and mineral were prescribed for the maximum of 90 days (5). Even though nutraceuticals have pharmaceutical benefits, only (24%) of the study population had received a higher secondary and above education, and most of the patients were unemployed or daily wages workers from low-income sources backgrounds, which shows the prescribed nutraceuticals exerted an additional economic burden.

In this study, the average cost of each prescription due to the nutraceuticals was found to be 440.55 INR, whereas the maximum cost per prescription was 1363 INR, and the minimum cost was found to be 35 INR. These results for the average cost per prescription of the nutraceuticals deviated from the study conducted by Shrestha R et al., (23) and Gosavi S et al., which showed that the average cost of each prescription in the Department of General Medicine was found to be NRs 575.78 [which is around 360 INR] and 219 INR for nutraceuticals respectively (6). Compared to other types of nutraceuticals, the highest average cost per prescription was found to be with enzymes (504.2±420.65 INR), followed by proteins (426.63±95.79 INR), vitamins+minerals (360.04±224.24 INR), and whereas the vitamins and probiotics cost found to be least (87±87 INR). The observed greater average cost of vitamins alone compared to the vitamin+probiotics was that vitamin+probiotics were prescribed for only one patient, whereas vitamin monotherapy was prescribed for more than (60%) of the patients.

Limitation(s)

This was part of an academic project, so the study period was only eight months. It could be better if the sample size were large. In addition, present study could be better if authors had observed nutraceuticals efficacy in blood sugar control.

Conclusion

Present study observed that vitamins, proteins, and minerals were the most frequently prescribed nutraceuticals, whereas enzymes and fibres were the least. Even though nutraceuticals are an integral part of the management of chronic diseases like T2DM, at the same time, patients are facing additional economic burdens due to these nutraceuticals. In this study, the cost per prescription of nutraceuticals was 440 INR. So, more research needs to be focused on the cost analysis of nutraceuticals among T2DM to eliminate the undesirable economic burden on patients.

Acknowledgement

The authors would like to thank the Head of Institution, NGSM Institute of Pharmaceuticals Sciences, Nitte (Deemed to be University), Mangaluru, Karnataka, India for permitting an opportunity to carry out this study.

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DOI and Others

DOI: 10.7860/JCDR/2022/59366.17366

Date of Submission: Jul 29, 2022
Date of Peer Review: Sep 19, 2022
Date of Acceptance: Oct 20, 2022
Date of Publishing: Dec 01, 2022

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? Yes
• For any images presented appropriate consent has been obtained from the subjects. No

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Aug 01, 2022
• Manual Googling: Sep 26, 2022
• iThenticate Software: Oct 18, 2022 (5%)

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