| CTRI Number |
CTRI/2025/03/082741 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Diet] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Millet Supplementation On Anthropometric Indices, Biochemical, Inflammatory and Body Composition Indices in Patients with Prediabetes and Type 2 Diabetes Mellitus. |
|
Scientific Title of Study
|
Effect of Millet Supplementation On Anthropometric Indices, Biochemical, Inflammatory and Body Composition Indices in Patients with Prediabetes and 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 |
Asia Sultana |
| Designation |
Principal Investigator |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Ilaj-bit-Tadbeer Faculty of Unani Medicine Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8755199034 |
| Fax |
|
| Email |
aasia.sultana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asia Sultana |
| Designation |
Principal Investigator |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Ilaj-bit-Tadbeer Faculty of Unani Medicine Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8755199034 |
| Fax |
|
| Email |
aasia.sultana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asia Sultana |
| Designation |
Principal Investigator |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Ilaj-bit-Tadbeer Faculty of Unani Medicine Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8755199034 |
| Fax |
|
| Email |
aasia.sultana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aligarh Muslim University |
|
|
Primary Sponsor
|
| Name |
Higher Education Financing Agency |
| Address |
Corporate Social Responsibility
(CSR), Ministry of Education, Government of India |
| 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 Shamama Usmani |
RAJIV GANDHI CENTER FOR DIABETES & ENDOCRINOLOGY JNMCH AND AJMAL KHAN TIBBIYA CCOLLEGE & HOSPITAL |
ALIGARH MUSLIM UNIVERSITY ALIGARH
Aligarh
UTTAR PRADESH |
08630643779
usmanishamama27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP 2 - Type 2 Diabetes Mellitus (Newly diagnosed) |
Two Finger Millet Tortilla/Chapattis twice a day |
| Intervention |
GROUP 4 – Type 2 Diabetes Mellitus (conventional diet) |
Two Finger Millet Tortilla/Chapattis twice a day |
| Intervention |
GROUP-1- Pre-Diabetes |
Two Finger millet Tortilla/ Chapattis twice a day |
| Intervention |
GROUP-3- Type 2 Diabetes Mellitus (on treatment) |
Two Finger Millet Tortilla/Chapattis twice a day |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
o Diagnosed patients of prediabetes and Diabetes.
o Age 18-65 years, both Genders.
o HbA1c: 5.7 % and above.
o Fasting BSL: 100 mg/dl and above.
o PP BSL/ Impaired Glucose Intolerance: 140 mg/dl and above.
o Patients who agree to sign informed consent and follow the protocol.
|
|
| ExclusionCriteria |
| Details |
o Pregnancy and lactation.
o Patients below the age of 18 and above the age of 65 years.
o Blood sugar level beyond the inclusion limits.
o Patients with systemic disorders like chronic renal failure and coronary artery disease.
o Patients who refuse to sign written consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOMES MEASURES-
• FBS
• PPBS
• HBA1C
• BMI
• Body Weight
• Body composition
• HOMA-Insulin Resistance Test
• Lipid profile
• USG Abdomen
|
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OUTCOMES MEASURES-
• Serum Calcium
• Leptin
• Adiponectin
• Haemoglobin
• TNF Alfa, IL-6, IL-10
|
6 Months |
SUBJECTIVE PARAMETERS-
1-Polydipsia
2-Burning sensations in hand & feet
3-Unexplained weight loss or weight gain
4- Unexplained fatigue
5- Sleep irregularity
6- Polyuria
7- Changes in Appetite
8- Darkening of Skin of certain parts of body |
6 months |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
Modification(s)
|
This project will evaluate the effect of finger millet in pre-diabetics, newly diagnosed diabetics and diabetic already on treatment. Apart from providing nutrition, Finger Millet is low in carbohydrate having low glycaemic index, it counters insulin resistance, and also helpful in dyslipidaemia, fatty liver and cardiovascular manifestations which are the late sequel of diabetes mellitus. The study is Randomized, Single Blind, Multi- Arm Intervention Study. The participants will be taken from OPD and IPD patients of the department of Ilaj-bit-Tadbeer of Ajmal Khan Tibbiya College and Hospital and Rajiv Gandhi Centre for Diabetes and Endocrinology, JNMCH, AMU, Aligarh will be included in the study on the basis of inclusion and exclusion criteria and diagnosed by subjective and objective parameters as mentioned in the protocol. The diagnosed patients will be divided into four groups with 100 patients in each group- GROUP 1 –Pre diabetes GROUP 2 - Type 2 Diabetes Mellitus (Newly diagnosed) GROUP 3 – Type 2 Diabetes Mellitus (on treatment) GROUP 4 – Type 2 Diabetes Mellitus (conventional diet) All the four groups will be given same intervention. Finger millet flour will be provided to the patients in the quantity of 100 gm divided in two doses of 50 gm each in the form of chapatti/tortilla to be taken twice (lunch & dinner) a day for 6 months and follow-up after twice in 3 months. All results will be analyzed statistically & will be discussed in detail. |