| CTRI Number |
CTRI/2025/08/093059 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of the effectiveness to two ayurvedic medicines in managing diabetes. |
|
Scientific Title of Study
|
A clinico comparative study of pramehahar kashaya ghanavati and katak khadiradi kashaya ghanavati in the management of madhumeha with special reference to diabetes mellitus DM type 2 |
| 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 Pooja Maida |
| Designation |
Post Graduation Resident |
| Affiliation |
pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
| Address |
pt khushilal sharma govt(auto) ayurveda college and institue bhopal madhya pradesh
Room No 221 department of kayachikitsa pt khushilal sharma govt(auto) ayurveda college and institue bhopal madhya pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9752137807 |
| Fax |
|
| Email |
pooja.maida7807@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shraddha Sharma |
| Designation |
Lecturer |
| Affiliation |
pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
| Address |
pt khushilal sharma govt(auto) ayurveda college and institue bhopal madhya pradesh
Room No 221 department of kayachikitsa pt khushilal sharma govt(auto) ayurveda college and institue bhopal madhya pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8109352936 |
| Fax |
|
| Email |
drshraddha.sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Maida |
| Designation |
Post Graduation Resident |
| Affiliation |
pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
| Address |
pt khushilal sharma govt(auto) ayurveda college and institue bhopal madhya pradesh
Room No 221 department of kayachikitsa pt khushilal sharma govt(auto) ayurveda college and institue bhopal madhya pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9752137807 |
| Fax |
|
| Email |
pooja.maida7807@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt khushilal sharma govt autonomous ayurveda college and institue bhopal madhya pradesh |
|
|
Primary Sponsor
|
| Name |
Pt khushilal sharma govt autonomous ayurveda college and institue bhopal |
| Address |
pg department of kayachikitsa Pt khushilal sharma govt autonomous ayurveda college and institue bhopal madhya pradesh |
| Type of Sponsor |
Government funding agency |
|
|
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 Pooja Maida |
pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
Room No 221 department of kayachikitsa pt khushilal sharma govt(auto) ayurveda college and institue bhopal madhya pradesh
Bhopal
MADHYA PRADESH |
9752137807
pooja.maida7807@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt Khushilal Sharma Government Autonomous Ayurveda College and Institution Bhopal Madhyapradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pramehahar Kashaya Ghanavati, Reference: Sidhayoga sangraha prameha rogadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Katak Khadiradi Kashaya Ghanavati, Reference: Sahastrayoga , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
31.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Fasting plasma glucose more than 126 mg per dl and less than or equal to 200mg per dl.
Or post load plasma glucose more than 200 mg per dl and less than or equal to 350 mg per dl.
Or HbA1c more than 6.5 percent and less than or eual to 10 percent.
Recently diagnosed cases of DM2.
Patient who will give written consent to participate. |
|
| ExclusionCriteria |
| Details |
Malignant and accelerated hypertension
CVS disorder (CAD)
Pregnant women and lactating mother
CNS disorder e.g., encephalopathy etc
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study we will be able to evaluate the efficacy of pramehahar kashaya ghanavati and katak khadiradi kashaya ghanavati in madhumeha with special reference to Diabetes Melitus Type 2. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
It is expected that at the end of the study we will be able to evaluate the efficacy of pramehahar kashaya ghanavati and katak khadiradi kashaya ghanavati in madhumeha with special reference to diabetes melitus type 2 |