| CTRI Number |
CTRI/2023/07/054915 [Registered on: 06/07/2023] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of some Ayurvedic drugs on Diabetes/Sugar |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATHADI KWATHA IN MANAGEMENT OF MADHUMEHA W.S.R.TO DIABETES MELLITUS 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 |
Pushpa Dagdu Gawale |
| Designation |
Professor |
| Affiliation |
Dhanwantari Ayurved college Udgir dist Latur |
| Address |
Dept.of Kayachikitsa, Dhanwantari Ayurved college Udgir dist Latur.
Dhanwantari Ayurved college Udgir dist Latur
Latur
MAHARASHTRA
413517
India |
| Phone |
09420211572 |
| Fax |
|
| Email |
gawalepushpa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Nimbalkar Naresh |
| Designation |
Asso.Professor |
| Affiliation |
CSMSS Ayurved college Aurangabad |
| Address |
Dept.of Kayachikitsa,CSMSS Ayurved college Aurangabad/Sambhajinagar
Dept.of Kayachikitsa,CSMSS Ayurved college Aurangabad/Sambhajinagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9422711098 |
| Fax |
|
| Email |
ayushakti009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Nimbalkar Naresh |
| Designation |
Asso.Professor |
| Affiliation |
CSMSS Ayurved college Aurangabad/ Sambhajinagar |
| Address |
Dept. Of Kayachikitsa CSMSS Ayurved college Aurangabad/Sambhajinagar
Dept.of Kayachikitsa CSMSS Ayurved college Aurangabad/Sambhajinagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9422711098 |
| Fax |
|
| Email |
ayushakti009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhanwantari Ayurved college Udgir dist.latur |
|
|
Primary Sponsor
|
| Name |
Pushpa Dagdu Gawale |
| Address |
Om nagar degloor road Udgir dist Latur |
| Type of Sponsor |
Private 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 |
| Pushpa Gawale |
Dhanwantari Ayurved college Udgir dist Latur |
Dept.of Kayachikitsa
Latur
MAHARASHTRA |
09420211572
gawalepushpa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
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, (2) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathadi kwatha, Reference: Ashtang Hridyam, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: -kwatha will made by bhaishjya vidhi | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Phaltrikadi kwatha, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Frequent micturation,Avil mutrata,Atikshudha,Pipasa,Dourbalyata,Hastoaddah,BSL level-126 -280mg/dl, receiving oral hypoglycemic drugs,Hba1c more than 6.5 |
|
| ExclusionCriteria |
| Details |
Patients having BSLmore than 280mg/dl, receiving Insulin,pts having hepatic and renal diseases, contagious diseases, Juvenile Diabetes mellitus, complications like retinopathy, neuropathy and gangrene,Diabetic ketoacidosis, pregnant and lactating women,pts below 20years and more than 60 years |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequent micturation after treatment% before treatment |
At three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood sugar level before & after treatment |
At three months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
14/07/2023 |
| 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="2"
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
|
In Astang Samhita there is a reference that Pathadi Qwatha is effective in Madhumeha.This Qwatha is a decoction of very less drugs which are easily available in market.So the purpose of study is to give the effective treatment at low economic costs. |