| CTRI Number |
CTRI/2024/07/071364 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect Of Millet-Based Diet In The Control Of Blood Sugar Level In Type 2 Diabetes Mellitus Cases – A Randomized Controlled Clinical Study |
|
Scientific Title of Study
|
Assessment of the effect Of
KODO and Sorghum based millet diet in the control of blood sugar level in type-II diabetes mellitus cases- a randomized control clinical study |
| 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 Monica Yadav |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal Sharma government ayurvedic college Bhopal |
| Address |
OPD NO 8 , Department of Swasthvritta
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9584097715 |
| Fax |
|
| Email |
monicayadav2995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Charu Bansal |
| Designation |
Professor |
| Affiliation |
Pt. Khushilal Sharma government ayurvedic college Bhopal |
| Address |
Department of Swasthvritta and Yoga,
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425017573 |
| Fax |
|
| Email |
bansalcharu73@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica Yadav |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal Sharma government ayurvedic college Bhopal |
| Address |
OPD NO 8 , Department of Swasthvritta
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9584097715 |
| Fax |
|
| Email |
monicayadav2995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute Bhopal |
|
|
Primary Sponsor
|
| Name |
Dr Monica Yadav |
| Address |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College and Institute Bhopal (M.P) pincode-462003
|
| Type of Sponsor |
Other [self] |
|
|
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 Monica Yadav |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute Bhopal |
OPD NO-8 , Department of Swasthvritta and Yoga
Bhopal
MADHYA PRADESH |
9584097715
monicayadav2995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College and Institute Bhopal (M.P) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: dietary advice of kodo and sorghum millets in both lunch and dinner time. , Ritucarya: nil, Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Kodo millet pulao or Sorghum millet daliya at the evening and sorghum flour-based chapatti along with dal and seasonal vegetables for 45 days, Apathya:restriction of excessive consumption of fat, salt, red meat, refined flour, junk food, late night food consumption | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: placebo of semolina capsule will be given for 45 days, Ritucarya: nil, Acara Rasayana:nil, Other:, Pathya/Apathya:yes, Pathya:no change, Apathya:no change |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Persons between the age group of 30 to 50 years Resident of Bhopal.
Willful to join the study.
Subjects of either sex.
Known case of Diabetic patients but not undergoing medication.
Type 2 diabetes mellitus patients those Plasma glucose level in the range of between Fasting (8 hour):126-200mg/dl or/and Post prandial after 2 hour:200-250mg/dl will be selected.
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Type 2 diabetes mellitus patients suffering from severe systemic illness.
Type 2 diabetes mellitus patients with chronicity of more than 5 years
BMI more than 35.
Thyroid abnormalities and other hormonal disorders
Patients with Type-I Diabetes Mellitus (IDDM).
Mentally retarded and who is unable to give their consent.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study, proposed regimen of millet based diet will reduce blood sugar levels and aids in management of diabetes |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate changes in weight, BMI, abdominal obesity & WHR of type 2 diabetes mellitus patients. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
06/08/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Millets are used in treating many diseases that have aetiology of dietetic error of modern life style. Kodo and Sorghum have been reported with significant hypoglycemic effect hence this clinical study has been proposed to identified the functional effect of millets based food on various clinical and biochemical parameters in Type II Diabetic patients. |