Evaluation of the Comparative Efficacy of an Ayurvedic Formulation (Nimba-Amalakyadi Powder) vs Metformin in the Management of Type 2 Diabetes Mellitus: Protocol for a Pilot Study
Bibliographic record
Abstract
Background: In Ayurveda, Prameha (diabetes mellitus) is considered Ashtamahagada Vyadhi (one among eight diseases difficult to treat and cure). Tridosha (three bio-humor in Ayurveda) with certain metabolic factors are involved in its pathogenesis. Frequent urination is a common symptom of this disease. Diabetes mellitus can be confused with type 2 diabetes mellitus in conventional science due to the resemblance in cardinal features. Objective: The primary objectives of this pilot study are to assess feasibility through recruitment, retention, adherence, data completeness, and participant acceptability. It also aims to estimate variability in outcome measures like fasting blood sugar and glycated hemoglobin (HbA1c). The secondary, exploratory objective is to observe trends in these clinical indicators to inform effect size assumptions for future trials. Methods: In this pilot study 36 individuals with type 2 diabetes mellitus will be recruited and split into two equal groups at random. In Group A (Control), metformin tablets (500 mg) will be prescribed daily once before lunch with plain water for 45 consecutive days. In Group B (Interventional group), the Nimba-Amalakyadi formulation will be prescribed 5 grams twice daily with an empty stomach (ie, 7 AM-5 PM) with lukewarm water for 45 consecutive days. Follow-up will be taken on days 45 and 90 to study the sustained effect of the drug. Results: The preliminary analysis of participant responses began in January 2025. Final results from this phase are expected to be available by June 2025. Recruitment rate (number recruited/month), eligibility rate (number eligible/number screened), retention rate at 45 days, compliance with intervention (percentage of prescribed doses taken), adherence to follow-up investigations, acceptability of intervention (based on participant-reported feedback), and data completeness rates are variables. Moreover, changes in the objective parameters, ie, reductions in blood sugar level (fasting and postprandial) and HbA1c values of patients will be also observed and recorded. Conclusions: A conclusion will be drawn according to the clinical findings obtained at baseline and follow-up visits with biochemical reports of the patients. The trial will prove the feasibility and comparative efficacy of Nimba Amalakyadi formulation versus metformin tablets for the management of type 2 diabetes mellitus.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".