| CTRI Number |
CTRI/2025/04/085314 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Dietary intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of Ayurveda based personalized diet plans on Diabetes Mellitus |
|
Scientific Title of Study
|
Impact of Ayurveda menu plans along with Ayurveda based intensive personal nutritional counselling program on Diabetes Mellitus Type 2: Two arm parallel design randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma Kumari |
| Designation |
Ph.D Scholar |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
Room No. 603, Sixth Floor, Academic Block, All India Institute of Ayurveda, Gautam Puri, Sarita Vihar, Mathura Road, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
7807254276 |
| Fax |
|
| Email |
sushma0767@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shiva Kumar S Harti |
| Designation |
Additional Professor, Department of Swasthavritta |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
Room No. 602, Sixth Floor, Academic Block, All India Institute of Ayurveda, Gautam Puri, Sarita Vihar, Mathura Road, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9611275434 |
| Fax |
|
| Email |
shivakumarsharti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shiva Kumar S Harti |
| Designation |
Additional Professor, Department of Swasthavritta |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
Room No. 602, Sixth Floor, Academic Block, All India Institute of Ayurveda, Gautam Puri, Sarita Vihar, Mathura Road, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9611275434 |
| Fax |
|
| Email |
shivakumarsharti@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr. Sushma Kumari |
| Address |
Room No. 603, Sixth Floor, Academic Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathuira road, New Delhi 110076 |
| 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 Sushma Kumari |
All India Institute of Ayurveda, New Delhi |
Room No. 603, 6th Floor, Department of Swasthavritta, Academic Block.
New Delhi
DELHI |
07807254276
sushma0767@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:E11||Type 2 diabetes mellitus. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | | Conventional meals with optimization of energy intake and Macronutrients percentage, Motivational Interviewing, Regular health check-up, Visualization of Diabetes risk factors: Blood and Urine biochemical parameters, BMI, Waist Circumference, Regular feedback about implementation of program in day-to-day routine, Feedback about the program, Physical activity: 150 min of Moderate intensity aerobic Exercise a week, Walking, Cycling, etc. (American association of Diabetes). | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Ayurvedic Diet Menu Plans with optimization of energy intake and Macronutrients percentage, Motivational Interviewing, Regular health check-up, Visualization of Diabetes risk factors: Blood and Urine biochemical parameters, BMI, Waist Circumference, Regular feedback about implementation of program in day-to-day routine, Feedback about the program, Physical activity: 150 min of Moderate intensity aerobic Exercise a week, Walking, Cycling, etc. (American association of Diabetes)., Pathya/Apathya:, Pathya:, Apathya: |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
2. For Prediabetic condition: A fasting plasma glucose level of 100 to 125 mg/dL (5.55-6.94 mmol/L), 2-hour postload glucose level of 140 to 199 mg/dL (7.77-11.04 mmol/L), HbA1c level of 5.7% to 6.4%,
3. Diagnosed DM Type 2: A fasting plasma glucose level of 126 mg/dL (6.99 mmol/L) or greater upto 200mg/dL (11.1mmol/L), a 2-hour postload glucose level of 200 mg/dL (11.1 mmol/L) or greater up to 280 mg/dL (15.5mmol/L), HbA1c level of 6.5% or 11%. will be included.
4. Any one of these is high.
|
|
| ExclusionCriteria |
| Details |
1. DM Type 1, DM Type 2 on insulin, Diabetes induced due to endocrinopathies like acromegaly, Cushing syndrome etc.
2. Other diseases like Renal dysfunction, Liver disease, Unmanaged thyroid disease,
3. Chronic alcoholism,
4. Acute or chronic inflammatory diseases.
5. Pregnant, breast feeding women
|
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in FBS by using Ayurveda diet menu plans along with Ayurveda based intensive personal nutritional counselling program. |
The Baseline, 30th Day, 90th day of intervention period and after 30 days post intervention follow up period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in biochemical biomarkers i.e., HbA1C and PPBS.
2. Reduction in other Diabetes Risk factor i.e., S. Insulin, HOMA IR, S. Triglycerides, Tr.G. index.
3. Reduction in CRP, Total Cholesterol.
4. Reduction in BMI, Body weight, Waist Circumference, BP.
5. Reduction in Subjective criteria.
|
The outcome will be assessed at the end of 90 days’ intervention period and at the end of 30 days’ post intervention follow up period. |
|
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Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
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 3 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to sushma0767@gmail.com
- For how long will this data be available start date provided 01-07-2027 and end date provided 30-06-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
Primary objective of this study is Evaluation of the Impact of defined Ayurvedic menu plans along with Ayurveda based intensive personal nutritional programme on Diabetes Mellitus type 2. Secondary objectives: - Identification of variables (e.g. problems, conflicts, possibilities for motivation) influencing nutritional behavior of study participants and reasons for failing to comply.
- Derivation of tailor-made, practicable recommendations for the target group.
- To observe the duration of the effect and/or any adverse effect and/or late effect of the intervention during follow up.
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