| CTRI Number |
CTRI/2026/02/104222 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [LIFESTYLE MODIFICATION] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Mustadi Kashaya Ghanavati and Lifestyle Modification in the management of Prediabetes |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF MUSTADI KASHAYA GHANAVATI AND LIFESTYLE MODIFICATION IN THE MANAGEMENT OF PREDIABETES |
| 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 Mohammed Reehan |
| Designation |
PG Scholar |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital, Bengaluru |
| Address |
Room No: 5 Department of Kayachikitsa, Department of PG studies Division, Sushrutha Ayurvedic Medical College and Hospital Prashanti Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
KARNATAKA
560105
India |
| Phone |
9110830489 |
| Fax |
|
| Email |
mohammedreehan.1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sowmya S B |
| Designation |
Professor |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital, Bengaluru |
| Address |
Room No: 5 Department of Kayachikitsa, Department of PG studies Division, Sushrutha Ayurvedic Medical College and Hospital Prashanti Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
KARNATAKA
560105
India |
| Phone |
9916149850 |
| Fax |
|
| Email |
drsbsowmya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammed Reehan |
| Designation |
PG Scholar |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital, Bengaluru |
| Address |
Room No: 5 Department of Kayachikitsa, Department of PG studies Division, Sushrutha Ayurvedic Medical College and Hospital Prashanti Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
KARNATAKA
560105
India |
| Phone |
9110830489 |
| Fax |
|
| Email |
mohammedreehan.1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa, Department of Pg Studies,Sushrutha Ayurvedic Medical College and Hospital Prashanti Kuteeera Jodi Bingipura , Jigani Hubli, Anekal taluk ,Bengaluru 560105 |
|
|
Primary Sponsor
|
| Name |
Dr Mohammed Reehan |
| Address |
Room No 5 Department of Kayachikitsa, Department of Pg Studies,Sushrutha Ayurvedic Medical College and Hospital Prashanti Kuteeera Jodi Bingipura , Jigani Hubli, Anekal taluk ,Bengaluru 560105 |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sushrutha Ayurvedic Medical College and Hospital Bengaluru |
Prashanti Kuteeera Jodi Bingipura , Jigani Hubli, Anekal taluk ,Bengaluru 560105 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohammed Reehan |
Sushrutha Ayurvedic medical College And Hospital , Bengaluru |
Room No. 5, Department of Kayachikitsa, Sushrutha Ayurvedic medical college and Hospital , Prashanti Kuteeera Jodi Bingipura , Jigani Hubli, Anekal taluk ,Bengaluru 560105
Bangalore
KARNATAKA |
9110830489
mohammedreehan.1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee SAMC and H |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: Exercise Programme (increase in aerobic physical activity), like a moderate brisk walk
for 150 minutes per week or 30 minutes 5 days a week.
, Ritucarya: , Acara Rasayana:Cessation of Smoking.
Avoiding Alcohol Intake., Other:Quality Sleep (WHO recommended 7-8 hours of sleep)[30], Pathya/Apathya:yes, Pathya:-Consuming a Healthy Diet
, Apathya:Avoiding Adhyasana (excessive intake of food),
Vishamashana (Untimely food)
Minimizing the intake of Red Meat and Dairy
products, sweets, and any fresh grains. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MUSTADI KASHAYA GHANAVATI , Reference: Harita Samhita, Prameha Chikitsa Adhikara, Chapter 23, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Warm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects between the ages of 30 and 45 years will be considered.
2. For the selection of subjects, the screening will be done, and patients with impaired fasting blood sugar or presenting with symptoms of Prameha Purvarupa will be subject to further detailed history and laboratory investigation.
3. Patients have a Fasting Blood Sugar level of 100 to 120 mg/dL and an HbA1C of 5.7 to 6.4%
will be considered for the study.
4. Subjects who are willing to participate in the study and who give informed consent will be
considered.
|
|
| ExclusionCriteria |
| Details |
1. Subjects diagnosed with diabetes mellitus or drug-induced diabetes mellitus will be excluded.
2. Subjects with an immune deficiency or chronic major illness such as cancer, rheumatoid arthritis, SLE, or AIDS will be excluded.
3. Subjects who are on corticosteroids or any other medications or therapy that interfere with the study will be excluded.
4. Female subjects who are pregnant and/or lactating will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To evaluate the efficacy of Mustadi Kashaya Ghanavati in managing blood Sugar Levels
•To evaluate the efficacy of lifestyle modification in managing blood sugar levels
|
30th day
60th day
91st day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To compare the efficacy of Mustadi Kashaya Ghanavati and Lifestyle Modification in managing Blood Sugar Levels.
|
30th day
60th day
91st day
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/03/2026 |
| 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="2"
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
|
This study is a randomized, comparative clinical trial to evaluate the efficacy of lifestyle modification in Group A with a minimum of 30 subjects and Mustadi Kashaya Ghnavati 1 gm once daily after food in Group B for a minimum of 30 subjects in the management of prediabetes. The primary outcome is management of prediabetes, and the secondary outcome is to establish a relation between impaired HbA1c and blood sugar levels. |