| CTRI Number |
CTRI/2026/01/101688 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ayurvedic medicine in early stage of Diabetes. |
|
Scientific Title of Study
|
A Controlled Clinical Study of Mustadi Kashaya and Metformin in Prameha Purvarupavastha with special reference to 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 Sneha Sudhakar Kamre |
| Designation |
Phd scholar |
| Affiliation |
Shri Saptashrungi Ayurved Mahavidyalaya, Nashik |
| Address |
OPD of kaychikitsa, Shri Saptashrungi Ayurved Mahavidyalaya, Nashik
Kamal nagar,Hirawadi, Panchavati, Nashik-422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9284804848 |
| Fax |
|
| Email |
sneha0506kamre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha Sudhakar Kamre |
| Designation |
Phd scholar |
| Affiliation |
Shri Saptashrungi Ayurved Mahavidyalaya, Nashik |
| Address |
Shri Saptashrungi Ayurved Mahavidyalaya, Nashik
Kamal nagar,Hirawadi, Panchavati, Nashik-422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9284804848 |
| Fax |
|
| Email |
sneha0506kamre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Somdatta Bhaskarrao Kulkarni |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved college, Nashik |
| Address |
OPD of Kaychikitsa, Shree Saptashrungi Ayurved college, Kamal nagar,Hirawadi, Panchavati, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9860268117 |
| Fax |
|
| Email |
somdattak85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaychikitsa, Siddhakala Ayurved College, Sangamner |
|
|
Primary Sponsor
|
| Name |
Sneha Sudhakar kamre |
| Address |
Shree Saptashrungi Ayurved College, Kamal Nagar, Hirawadi, Nashik 422003 |
| 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 |
| Sneha Sudhakar Kamre |
Siddhakala Ayurved College, Sangamner |
Department of kaychikitsa, Opd no 01
Ahmadnagar
MAHARASHTRA |
09284804848
sneha0506kamre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Shree Saptashrungi nayurved, mahavidyalay, nashik |
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, (2) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mustadi Kashaya, Reference: Bharat Bhaishajya Ratnakar (Vol. 4), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet Metformin | Tablet Metformin 500mg
Frequency- OD
Duration- 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Signs and symptoms of Prediabetes and that of Prameha Purvarupavastha.
2. Newly diagnosed with Prediabetes (IFG between 100-125 and PPBS 140- 199)
3. Not suffering from any other chronic infections including HIV.
4. Having HbA1c between 5.7 to 6.4%.
|
|
| ExclusionCriteria |
| Details |
1. Age below 18years & above 65 years
2. Pregnant & lactating mothers.
3. Prior use of medication to treat diabetes except gestational diabetes
4. Have been diagnosed with diabetes by result of IFG more than or equal to 126mg/dl.
5. Patients having complications such as vasculopathy, nephropathy, retinopathy and neuropathy.
6. Patients having other systemic complications like hepatic, renal and cardiac problems.
7. Patients having poorly controlled blood pressure.
8. Pregnant and lactating females not included in this study.
9. Patients who are currently participating in any other clinical trials since last 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decreases the blood sugar level fasting and post prandial and HbA1c in Prediabetes After oral administration of Mustadi Kashaya for 90 days. |
0 day (1st visit), 30th day (2nd visit). 91st day ( Last follow up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To decreases the symptoms of Prameha Purvarupavastha with special reference to Prediabetes. |
0 day (1st visit), 30th day (2nd visit). 91st day ( Last follow up) |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
02/02/2026 |
| 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)
|
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 - NO
|
|
Brief Summary
|
Prediabetes, also called as intermediate
hyperglycemia, is a stage which is characterized by blood glucose levels which
are above normal but below the threshold defined for diabetes or having
impaired glucose tolerance. Prediabetes
were more frequent in urban than rural areas. In many states with a lower human
development index, the ratio of diabetes to prediabetes was less than 1. Diagnosis of Prameha
is confirmed with the help of criteria for diagnosis of DM. Therefore criteria
for diagnosis of Pre-diabetes can be beneficial to diagnosis of Prameha Purvarupavastha and help to specify the diagnostic criteria of Prameha Purvarupavastha. Prediabetes being in co-relation with Prameha purvarupavastha. This kalpa
can be successfully used in treating this condition of Prediabetes.
So
considering these points, the study will be undertaken to evaluate the role of Mustadi Kashaya in the management of
patients of Prameha purvarupavasatha. The efficacy of Mustadi Kashaya will be examined by
comparing it with the effect of metformin. Hence, a controlled clinical study
would be undertaken.
|