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

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Dr Mohan Z Mani

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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 : 2026 | Month : September | Volume : 20 | Issue : 9 | Page : JK01 - JK04 Full Version

Efficacy of Salmusta Yoga versus Tablet Metformin in Type 2 Diabetes Mellitus (Madhumeha): A Research Protocol for Randomised Controlled Trial


Published: September 1, 2026 | DOI: https://doi.org/10.7860/JCDR/2026/85697.24286
Diksha J Gaikwad, Sadhana Misar Wajpeyi, EAA Gamulea Andrei Florin

1. Postgraduate Scholar, Department of Kayachikitsa, Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod (H), Wardha, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Maharashtra, India. 2. Professor and Head, Department of Kayachikitsa, Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod (H), Wardha, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Maharashtra, India. 3. Educational Advocate of Ayurveda and Professor, Ayush Cell Romania (Bucharest, Romania); President and Ayurveda Lecturer - National Association for the Promotion of Unconventional Medicine - AMN-Romania (Bucharest, Romania).

Correspondence Address :
Dr. Diksha Jitendra Gaikwad,
Postgraduate Scholar, Department of Kayachikitsa, Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod (H), Datta Meghe Institute of Higher Education and Research (Deemed to be University), Wardha-442001, Maharashtra, India.
E-mail: diksha.gaikwad550@gmail.com

Abstract

Introduction: Diabetes mellitus is a metabolic disorder that can be correlated with Madhumeha, a type of Prameha in Ayurveda. This is a Santarpanajanya Vyadhi (Diseases caused by overnutrition), caused by Medo Dushti (disruption in fat metabolism) affecting Medovaha Strotas. Salmusta yoga, containing Sal (Shorea robusta) , Musta (Cyperus rotundus) , and Kampillaka (Mallotus philippensis) in Yogratnakar for the management of Prameha (Diabetes mellitus).

Need of the study: Type 2 Diabetes Mellitus (T2DM) is a rapidly increasing metabolic disorder with significant complications. Although modern treatments like insulin and metformin are effective, long-term use may cause adverse effects and does not fully address underlying metabolic disturbances. In Ayurveda, Madhumeha involves Kapha predominance, Medo Dushti, and Agnimandya, requiring a holistic approach. Shamana Chikitsa is preferred when Shodhana is not feasible. Salmusta yoga, described in Yogaratnakara, has Kapha-Medohara and Pramehaghna properties reported to have antihyperglycaemic effects. However, limited clinical evidence exists, highlighting the need to evaluate its efficacy in managing Madhumeha.

Aim: Evaluation of comparative efficacy of Salmusta yoga Versus tablet metformin in the management of diabetes mellitus type 2.

Materials and Methods: A single-blind (accessor blind) parallel randomised controlled trial will be conducted at the Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod (H) Wardha, Maharashtra, India, from September 2025 to March 2027. The study involves 64 patients meeting the inclusion criteria, randomly assigned into two groups of 32 each. Group 1 will receive Salmusta yoga, while Group 2 will receive tablet metformin twice a day for two months. Assessments of fasting and postprandial blood sugar level will be conducted on days 0, 30 and 60. Chi-square test, Student’s unpaired, and paired t-test will be used for both descriptive and inferential statistics. A significance level of p<0.05 will be applied.

Keywords

Blood glucose, Glucose metabolism disorders, Hyperglycaemia, Insulin resistance

Diabetes mellitus is a chronic metabolic disorder characterised by persistent hyperglycaemia and impairment of carbohydrate, fat, and protein metabolism. Diabetes is a major global health challenge, with an estimated 589 million adults in 2024 living with diabetes, of whom almost one-in-two were undiagnosed. In addition, another 1.1 billion adults worldwide had impaired glucose tolerance or impaired fasting glycaemia, predisposing them to an increased risk of developing T2DM (1). T2DM can be correlated with Madhumeha, a type of Vataja Prameha as per Ayurveda, due to the resemblance of clinical features. Elevated blood sugar levels caused by either insulin resistance or inadequate insulin are its defining feature (2). According to Acharya Charaka, it is mainly caused by the aggravation of Kapha Dos.ha. Aetiological factors include intake of Nava-anna (newly harvested grains less than one year old), excessive consumption of Dadhi Varga (curd and fermented milk preparations), Mamsa-sevana (meat intake) of Anupa, Gramya, and Audaka animals (marshy, domestic, and aquatic species-all Kapha-promoting), along with indulgence in Asya-sukha (sedentary habits such as constant sitting) and Svapna-sukha (excessive sleep). These factors collectively vitiated Kapha Dos.ha and subsequent obstruction (Srotorodha) of metabolic pathways, forming the basis of Prameha Samprapti. Prameha is mainly a Santarpanajanya Vyadhi, marked by predominance of Kapha Dos.ha, vitiation of Meda Dhatu, and involvement of Mutravaha Strotas (Urinary system), resulting in excessive and abnormal urination. It is characterised by profuse, turbid urination, reflecting systemic dysregulation of Medovaha Strotas and Agnimandya (diminished metabolic activity). All three

Dos.has-Vata, Pitta, and Kapha-are involved in its pathophysiology. Three basic therapeutic principles underpin Ayurved treatment of Prameha: Shamana Chikitsa (palliative or internal treatment), Shodhana Chikitsa (purification therapy), and Nidana Parivarjana (elimination or avoidance of causative factors). Within Shamana Chikitsa, classical scriptures describe several single and herbal compositions that help balance Kapha, rectify Medo Dushti, and restore Agni. One such formulation is Salmusta yoga, given by Acharya Yogaratnakara in the context of Prameha Chikitsa (3). It comprises Sal (Shorea robusta Gaertn. f.), Musta (Cyperus rotundus Linn.) , and Kampillaka (Mallotus philippensis (Lam.) Mull. -Arg.) . It demonstrates Kaphamedohara (lipid-reducing), Agnidipana (metabolism-enhancing), and Pramehaghna (antidiabetic) properties. Thus, Salmusta yoga treats the core causes-Agnimandya, Meda dushti, and Kapha Prakopa-and restores metabolic balance through its combined phytotherapeutic effects (4),(5),(6). Tablet metformin is a biguanide antihyperglycaemic agent and is considered the first-line drug for the management of diabetes mellitus (7).

Review of Literature

Prameha is a disease of Medovaha stotasa. It is mentioned in Brihattrayi and in Laghutrayi. It is included in the Ashtoumahagada by Acharya Charak. Hetu (causes), lakshana (symptoms), and samprapti (pathogenesis) of Prameha, including Madhumeha, are described in Sutrasthana and Nidanasthana of Charak Samhita. The 20 types of prameha, involvement of Dosha and Dushya and treatment are described in Chikitsasthana. Acharya Sushrut explains Madhumeha in Nidan sthana, while its treatment is explained in Chikitsa sthana.

Raut NA et al., conducted an animal study to prove the antidiabetic activity of hydro ethanolic extract of Cyperus rotundus in alloxan-induced diabetes in rats. Oral daily administration of 500 mg/kg of the extract (once a day for seven consecutive days) significantly lowered blood glucose level. This antihyperglycaemic activity can be attributed to its antioxidant activity, as its strong DPPH radical scavenging action in-vitro (8).

Zhang W et al., conducted an in-vivo study to evaluate the hypoglycaemic effect of the methanolic extract of Shorea roxburghii leaves in rats with streptozotocin-induced T2DM, developed using a high-fat diet and fructose solution. The results demonstrated significant improvements, including lowered fasting blood glucose levels, reduced body weight, and decreased food and water intake in treated diabetic rats. These findings suggest the promising antidiabetic potential of Shorea roxburghii leaf extract and support its possible use in future management of T2DM (9).

The study conducted by Tanmane CS et al., on Mustadikwath versus phalatrikadikwath for diabetes mellitus type 2 demonstrated statistically significant improvements in clinical symptoms of Madhumeha in both groups, along with reductions in fasting blood glucose, postprandial blood glucose, and HbA1c levels over the treatment period (10).

Singh P et al., conducted animal study and found that the ethanolic extract (250 and 500 mg/kg body weight) of Cyperus rotundus showed a significant reduction in blood glucose levels, as well as reduction in the elevated level of SGPT, SGOT, serum cholesterol, and triglycerides with Body Mass Index (BMI) in STZ diabetic mice, comparable to that of standard drug glibenclamide at the 21st day of the study. Thus, the extract exhibited antidiabetic activity in STZ induced diabetic mice, as evident from blood glucose levels (11).

Roy VK et al., conducted an animal study on the methanolic leaf extract of M. roxburghianus (MRME), which has shown a significant role of it in protecting animals from alloxan-induced diabetic oxidative stress in the pancreas and exhibited promising antihyperglycaemic and antioxidant activities along with significant reversal of disturbed antioxidant status and lipid peroxidative (12).

Similarly, Sumithira G et al., conducted an animal study to evaluate the antidiabetic activity of the Mallotus philippensis. They reported that alcoholic fruit extract of Mallotus philippensis decreased blood glucose, glycosylated haemoglobin and increased plasma insulin when administered orally for 21 days to STZ-induced diabetic rats with dose of 200 and 400 mg/kg. They demonstrated that rats treated with Mallotus philippensis alone showed a statistically significant antidiabetic effect compared to diabetic rats (13). However, limited clinical evidence exists on Salmusta yoga efficiency, highlighting the need to evaluate its efficacy in managing Madhumeha.

Therefore, present study aims to evaluate and compare the efficacy of Salmusta yoga versus tablet metformin in the management of diabetes mellitus type 2 (Madhumeha).

Objectives

Primary objective:
To evaluate the efficacy of • Salmusta yoga on FBS and PPBS levels in T2DM.
To evaluate the efficacy of tablet metformin on FBS and PPBS • levels in T2DM.

Secondary objective:
To compare the efficacy of • Salmusta yoga and tablet metformin on FBS and PPBS levels in T2DM.

Null hypothesis (H0): There is no significant difference in the efficacy of Salmusta yoga and tablet metformin in the management of T2DM (Madhumeha).

Alternative hypothesis (H1): There is a significant difference in the efficacy of Salmusta yoga and tablet metformin in the management of T2DM (Madhumeha).

Material and Methods

A single-blind, parallel randomised controlled clinical trial will be conducted at the Mahatma Gandhi Ayurveda College Hospital and Research Centre, Salod (H), Wardha, Maharashtra, from September 2025 to June 2027. Before enrollment, written informed consent will be obtained from all participants after the nature, purpose, and procedures of the study are explained. Ethical approval for the trial has been granted by the Institutional Ethics Committee (IEC) vide approval number MGACHRC/IEC/July-2025/953. The trial has been registered with the Clinical Trials Registry of India (CTRI) under registration number CTRI/2025/08/093684.

Inclusion criteria:

• Patients are ready to give written consent;
• Age between-31 years- 60 years of either gender.
• Criteria for diagnosis of DM by the American Diabetes Association (ADA) (14).
FBS ≥126 mg/dL up to 375 mg/dL and/or
• PPBS ≥200 mg/dL up to 500 mg/dL
• Newly diagnosed cases.

Exclusion criteria:

Known cases of-
• IDDM-Insulin dependent diabetes mellitus and patients taking Insulin therapy;
• Patients having chronic diabetes problems like retinopathy, neuropathy and nephropathy;
• Patients with juvenile diabetes;
• Pregnant and lactating women.

Sample size calculation:

n1=(σ12+σ2 2) (Z1-α/2+Z1-β)2/Δ2
? =difference between the group means
κ ratio of n2/n1
Z1-α/2=two-sided Z value (e.g., Z=1.96 for a 95% confidence interval)
Z1-β=statistical power.
Mean fasting blood glucose at day 75 in Vidangadi yoga Group=6.449 (15)
Mean fasting blood glucose at day 75 in metformin Group=7.820
σ1=SD of fasting blood glucose at day 75 in Vidangadi yoga Group=2.033
σ2=SD of fasting blood glucose at day 75 in metformin Group=1.678
For detecting mean difference of 1.370 i.e., Δ=7.820-6.449=1.370
K=1
N=(2.033×2.033+1.678×1.678) (1.96+0.84) 2
1.370×1.370
=28.98=29 patients needed in each group
Considering 10% dropout 29+3=32 in each group


A total sample size of 64 patients, comprising 32 patients in each group, will be selected using a simple randomisation technique employing a computerised random number table to ensure unbiased allocation and enhance internal validity (Table/Fig 1).

Randomisation 1:1 ratio using a computer-generated random number will be carried out by principal investigator. Block randomisation with variable block sizes will be applied to maintain group balance. Allocation concealment will be ensured by Sequentially Numbered, Opaque, Sealed, Envelopes (SNOSE). Group 1 will receive Salmusta yoga, while Group 2 will receive tablet metformin twice a day for two months (Table/Fig 2) (16),(17).

Withdrawal criteria: Patients who experience any negative effects or worsening of their symptoms will be excluded from the research.

Study Procedure

Preparation of the drug: Metformin 500 will be procured from a local pharmacy near Mahatma Gandhi Ayurveda College.

The raw drugs will be procured from the local authorised Ayurved market. The Department of Dravyagun.a, Wardha, will be responsible for the proper identification and authentication of the crude drugs. The formulation Salmusta yoga will be prepared in the GMP-certified Rasa Shala (Vedapoorna Unit) of MGACH & RC, under the supervision and guidance of qualified subject matter experts in Rasa Shastra and Dravyagun.a.

Authenticated raw materials

Sala Tvak, Musta and Sodhita Kampillaka will be taken in equal proportions

Each ingredient will be pulverised separately into fine powder (Churn.a)

Powders will be mixed thoroughly to obtain a homogeneous blend

Three sequential Bhavanas (triturations) will be done using fresh Amla Swarasa (Emblica officinalis juice) to enhance bioavailability and potency

Granules (Gola) will be prepared from the Bhavita Churn.a

Granules will be compressed to formulate Vati (tablets) following SOP from Sharngadhara Samhita, Madhyama Khanda, Vati Kalpana Adhyaya.


Outcomes

Primary outcomes: Reduction of Fasting Blood Sugar level (FBS);
Post Prandial Blood Sugar level (PPBS).
Secondary outcome: Comparison of both groups on FBS and PPBS;
Outcomes will be measured on days 0, 30, and 60 days.
Data management: The principal investigator will handle data coding.
Dissemination policy: Information will be disseminated through publication of articles, following established standards for authorship and appropriate use of professional writers. The Gantt chart of the present study is shown in (Table/Fig 3).

STATISTICAL ANALYSIS

Data will be analysed using Statistical Package for Social Sciences (SPSS) 27.0 software, and the Chi-square test, Student’s unpaired and paired t-test, will be used for both descriptive and inferential statistical analysis. A significance level of p<0.05 will be considered.

References

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Sastry JLN. Illustrated Dravyaguna Vijnana: Study of the Essential Medicinal Plants in Ayurveda. Vol. 2. Varanasi: Chaukhambha Orientalia; 2010. p. 78.
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DOI and Others

DOI: 10.7860/JCDR/2026/85697.24286

Date of Submission: Dec 06, 2025
Date of Peer Review: Jan 13, 2026
Date of Acceptance: May 16, 2026
Date of Publishing: Sep 01, 2026

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. Yes

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Jan 02, 2026
• Manual Googling: May 12, 2026
• iThenticate Software: May 14, 2026 (8%)

ETYMOLOGY: Author Origin

EMENDATIONS: 6

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