| CTRI Number |
CTRI/2025/09/094780 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to See if a Millet-Based Food Helps Control Blood Sugar and Improve Nutrition in People with Type 2 Diabetes |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial Evaluating the Efficacy of a Millet-Based Formulation on Glycemic Regulation and Nutritional Status in Patients with Type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Hareendran Nair |
| Designation |
Managing Director and Founder |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Room No 1 Department of Research and Development, Pankajakasthuri Herbal Research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447096201 |
| Fax |
|
| Email |
hareendrannair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya R |
| Designation |
Professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and PG Centre |
| Address |
Principal investigator
Room No 1
Dravyaguna department
Pankajakasthuri Ayurveda Medical College and PG Centre
Thiruvananthapuram
KERALA
695572
India |
| Phone |
6238651628 |
| Fax |
|
| Email |
vijivijayan5225@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaya R |
| Designation |
Professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and PG Centre |
| Address |
Principal investigator
Room No 1
Dravyaguna department
Pankajakasthuri Ayurveda Medical College and PG Centre
Thiruvananthapuram
KERALA
695572
India |
| Phone |
6238651628 |
| Fax |
|
| Email |
vijivijayan5225@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri herbals India Pvt Ltd
Poovachal, Trivandrum, Kerala-695575 |
|
|
Primary Sponsor
|
| Name |
DST-SHRI |
| Address |
technology Bhavan, New Mehrauli Road, Qutab Institutional Area, New Delhi-110016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijaya R |
Pankajakasthuri Ayurveda Medical College and PG Centre |
Room no: 1
Dravyaguna department
Pankajakasthuri Ayurveda Medical College & PG Centre, Killy, Kattakada
Thiruvananthapuram
KERALA
Thiruvananthapuram
KERALA |
6238651628
vijivijayan5225@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group for treatment |
The control group will not receive the millet-based ready-to-eat formulation. Instead, participants in this arm will continue with their standard of care dietary and medical management as prescribed by their treating physician for the study duration. No additional food supplement or placebo product will be provided. Participants will be advised to maintain their usual dietary practices and lifestyle, while their clinical parameters, dietary intake, and safety outcomes will be monitored at the same intervals as the intervention group. |
| Intervention |
Millet-Based Formulation |
The intervention consists of a ready-to-eat Little Millet Upma Mix, developed as a nutritional/food product in the form of a packed, rehydratable functional food. Each serving is provided as a pre-measured 40 g dry sachet, containing the complete formulation, which is to be rehydrated before consumption. Participants will consume one sachet (40 g) once daily with breakfast for a duration of 90 days (or as per the trial protocol). The route of administration is oral, as food. For preparation, the contents of a single sachet are emptied into a bowl or pan, to which approximately 100 ml of boiling water is added. The mixture is stirred briefly, covered, and allowed to rehydrate for 3–4 minutes, or alternatively heated gently for 1–2 minutes until water is absorbed. Participants may add warm milk or ghee as per personal preference, and the product should be consumed immediately after preparation. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 30–70 years
Diagnosed with Type 2 Diabetes Mellitus (as per ADA 2023 guidelines)
HbA1c between 6.5% and 9.0%
On stable oral hypoglycemic agents for at least 3 months
Willing to replace dinner with study formulation
Provided written informed consent
|
|
| ExclusionCriteria |
| Details |
Insulin-dependent diabetics
Chronic liver, kidney, thyroid dysfunction or cardiac diseases
History of gastrointestinal disorders
Allergy to millets or cereal grains
Pregnant or lactating women
Participation in other clinical trials in the last 3 months
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in HbA1c, FBS, PPBS, and OGTT response
Change in vitamins (A, B2, B6, B12, D3) and microminerals (Magnesium, Calcium, Zinc, Phosphorus, Manganese, Copper, Selenium) |
Baseline (0th day) and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Liver Function Tests (LFT), Renal Function Tests (RFT), and Lipid profile (TC, LDL, HDL, TG)
Change in hematological profile (CBC) and Quality of Life (QOL) using a validated diabetes-specific QOL scale |
Baseline (oth day) and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/09/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder marked by insulin resistance and hyperglycemia, often leading to vascular and metabolic complications. Dietary modification plays a critical role in its management. Millets, particularly Panicum sumatrense, are rich in fibre, slowly digestible starches, micronutrients, and antioxidants, with a low glycemic index. However, robust clinical evidence on their effect in T2DM is limited. Objective: To evaluate the efficacy of a millet-based formulation as a dietary adjunct on glycemic control and nutritional status in patients with T2DM. Methods: This is a 90-day, randomized, open-label, two-arm, parallel-group controlled clinical trial conducted at a dedicated clinical research unit. Ninety-four participants with T2DM (HbA1c 6.5–9.0%, aged 30–70 years) will be randomized (1:1) into intervention (n=47) and control (n=47) groups. The intervention group will receive 150 g of a millet-based formulation at night, replacing regular dinner, along with standard diabetic care; the control group will receive standard care only. Assessments will be performed at baseline, Day 45, and Day 90. Primary Endpoints: Changes in glycemic parameters (HbA1c, Fasting Blood Sugar, Postprandial Blood Sugar, Oral Glucose Tolerance Test) and nutritional biomarkers (Vitamins A, B2, B6, B12, D3; microminerals: Mg, Ca, Zn, P, Mn, Cu, Se). Secondary Endpoints: Changes in liver and renal function tests, lipid and hematological profiles, and quality of life (QOL) using a validated diabetes-specific scale. Analysis: Between-group differences will be evaluated using independent t-tests/Mann-Whitney U tests, with repeated measures ANOVA or mixed models for longitudinal analysis. Both intention-to-treat and per-protocol analyses will be performed. Expected Outcomes: The millet-based formulation is anticipated to improve glycemic control, enhance vitamin and mineral bioavailability, positively modulate biochemical parameters, and improve QOL in T2DM patients. Conclusion: This trial will provide scientific evidence on the role of millet-based formulations as a sustainable, low-cost dietary intervention for glycemic regulation and nutritional improvement in T2DM management. |