| CTRI Number |
CTRI/2022/09/046025 [Registered on: 29/09/2022] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the efficacy of Pramehhara Kwatha in the management of Madhumeha w.s.r. to Type II Diabetes Mellitus |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Pramehhara Kwatha in the management of Madhumeha w.s.r. to Type II Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Vijay Chaudhary |
| Designation |
Principal-cum-Dean |
| Affiliation |
Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital Paprola (H.P) |
| Address |
Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital Paprola (H.P)
Principal office Ground Floor of Administrative Block of Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital Paprola (H.P)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manik Soni |
| Designation |
lecturer |
| Affiliation |
Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital Paprola (H.P) |
| Address |
Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital Paprola (H.P)
room no. 205 Kayachikitsa deptt. 1st floor of Anatomy Block of Rajiv Gandhi Govt. Ayurvedic Post Graduate College and Hospital Paprola H.P
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816842425 |
| Fax |
|
| Email |
drmsony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anant Bhardwaj |
| Designation |
P.G. Scholar |
| Affiliation |
Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital Paprola (H.P) |
| Address |
Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital Paprola (H.P)
Room no. 317 2nd floor of Hospital Building (Kayachikitsa Deptt.) of Rajiv Gandhi Govt. Ayu. Post Graduate College and Hospital Paprola (H.P)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816842425 |
| Fax |
|
| Email |
abhimachali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy, Paprola Distt. Kangra H.P. Self Charak Pharmacy RGGPG Ayu. College and Hospital ,Paprola |
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
R.G.P.G.Ayu. College and Hospital Paprola (H.P) |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Prof Vijay Chaudhary |
RAJIV GANDHI GOVERNMENT POST GRADUATE AYURVEDIC COLLEGE & HOSPITAL PAPROLA – DISTT. KANGRA (H.P.) |
RAJIV GANDHI GOVERNMENT POST GRADUATE AYURVEDIC COLLEGE & HOSPITAL PAPROLA – DISTT. KANGRA (H.P.) OPD no. 207 and 220 and IPD room no 317 of hospital building in Kayachikitsa Department
Kangra
HIMACHAL PRADESH |
9418130228
drvijaychaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionaEthicalCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E110||Type 2 diabetes mellitus with hyperosmolarity. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | tab. Metformin 1g | tab. Metformin 1g twice a day for 12 weeks | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pramehhar Kwatha , Reference: à¤à¥ˆo रo पà¥à¤°à¤®à¥‡à¤¹à¤°à¥‹à¤—ाधिकार 37/6, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: 50 gm raw drug in 800ml water reduced it to 100 ml liquid i.e.divided into 2 equal doses |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of type 2 diabetes mellitus having
a. Fasting Plasma Glucose -126 to 200 mg/dl
b. PPBS(2-hour Plasma Glucose Level) – 200 to 400 mg/dl
c. HbA1C between - 6.5% to 9%
|
|
| ExclusionCriteria |
| Details |
Subjects suffering from the complications of diabetes mellitus i.e. Diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc. which require an urgent treatment.
Patients having major medical illness like cancer, concurrent infection like tuberculosis.
Patients with uncontrolled hypertension.
Patients with established diagnosis of CAD or any other clinically significant cardiovascular disease.
Renal dysfunction (defined by eGFR< 60ml/min calculated by MDRD calculator).
Subjects who have completed participation in any other clinical trial during the past 3 months.
Subjects with haemoglobin percentage < 9 gm% for males and < 8gm% for females.
Subjects with concurrent hepatic dysfunction (defined as AST and/or ALT >3 times of the upper normal limit)
Uncontrolled acute pulmonary dysfunction requiring inhalational or systemic steroids.
Pregnant/ lactating women.
Subjects on systemic or oral steroids, oral contraceptives pills or estrogen replacement therapy.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of an Ayurvedic formulation Pramehhara Kwatha independently and also as add on therapy to Metformin for glycemic control in management of Madhumeha.
|
Patient will be assessed after 2 weeks, 4 weeks, 8 weeks and at the end of trial (i.e 12 weeks).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the clinical safety of Pramehhara Kwatha in management of Madhumeha w.s.r. to Type II Diabetes Mellitus.
|
At the 8th week and 12th week and remain connected with patients telephonically to know the A.D.Rs if there is any after completion of trial.
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2022 |
| Date of Study Completion (India) |
21/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published in International journal of medical research and health sciences 2025-14(1):1-22 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
I would like to publish my trial after completion of the trial as soon as possible. Patients will be selected from OPD/IPD of RGGPG Ayurvedic College & Hospital Paprola. A sample of 30 diabetic patients will be registered. Patients will be divided randomly into three groups. Patients will be assessed to evaluate the effect of Pramehhara Kwatha in the management of Madhumeha w.s.r to Type II Diabetes Mellitus. |