| CTRI Number |
CTRI/2025/03/082086 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of NISHA-AMALAKI TAB & VACHAHARIDRADI GANA TAB in the management of MADHUMEHA w.s.r. DIABETES MELLITUS. |
|
Scientific Title of Study
|
Randomised comparative clinical study to evaluate the efficacy of nisha-amalaki tab and vachaharidradi gana tab in the management of madhumeha w.s.r. to diabetes mellitus |
| 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 Maneesh Kumar |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Kaya Chikitsa Department Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9785811004 |
| Fax |
|
| Email |
maneeshsalodia007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indumati Sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Kaya Chikitsa Department Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India |
| Phone |
7976972310 |
| Fax |
|
| Email |
drindusharma4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indumati Sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Kaya Chikitsa Department Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 India
Udaipur
RAJASTHAN
313001
India |
| Phone |
7976972310 |
| Fax |
|
| Email |
drindusharma4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan mohan malviya govt ayurved college, udaipur, rajasthan pin 313001
|
|
|
Primary Sponsor
|
| Name |
Madan mohan malviya government ayurved college udaipur |
| Address |
Madan mohan malviya govt ayurveda college udaipur rajasthan pin code 313001
|
| 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 |
| Dr Maneesh Kumar |
Madan mohan malviya govt ayurveda college udaipur |
Opd no 3,kaya chikitsa department,Madan mohan malviya govt ayurveda college udaipur rajasthan pin code 313001
Udaipur
RAJASTHAN
Udaipur
RAJASTHAN |
9785811004
maneeshsalodia007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutinal ethics committee mmm govt ayurved college ambamata udaipur raj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: VACHAHARIDRADI GANA , Reference: A.H. Sutrasthan 15/35-36 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NISHAAMALAKI TAB , Reference: A.H. Chikitsasthan 12/5 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed & confirmed cases of Diabetes Mellitus Type 2
2. Age 18 – 70 years
3. Patients having Fasting Blood Sugar below 300mg/dl
4. Patients who agree for the trial and fill the consent form |
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 18 years and above 70 years
2. Severely Uncontrolled Blood Sugar Level
3. Patients having Fasting Blood Sugar above 300mg/dl
4. Pregnant and lactating females
5. Life threatening conditions
6. Type-1 Diabetic mellitus
7. Pancreatitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief in sign and symptoms |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Find changes in HbA1C
Find changes in average RBS
Find changes in average FBS
Find changes in Urine-RE, ME |
90 Days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="0"
Months="11"
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
|
RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF NISHA
AMALAKI TAB AND VACHAHARIDRADI GANA TAB IN THE MANAGEMENT OF MADHUMEHA
W.S.R. TO DIABETES MELLITUS
There will be two group in the study. in Group A randamly selected and clinically diagnosed 30 patient of Madhumeha will be given NISHA AMALAKI TAB twice a day after meal, Group B 30 patient of Madhumeha will be given VACHAHARIDRADI GANA TAB twice a day after meal. both, trial will be conduct for a period of 3 months. Follow up of the case will be after 15 days that is six time during treatment. Final assesment will be done after completion of one month course on the basis of subjective and laborateral assesment. |