| CTRI Number |
CTRI/2024/10/074698 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare effect of TRIPHALA-NIMBADI Churna and NISHAMALAKI Churna in diabetes. |
|
Scientific Title of Study
|
An etiopathological study of madhumeha w.s.r. to diabetes mellitus type 2 and evaluation of comparative therapeutical effect of TRIPHALA-NIMBADI Churna(KALPIT) and NISHAMALAKI Churna. |
| 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 Gopal Singh Bithu |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Govt Ayurved College |
| Address |
OPD no.4 PG Department of Rog Nidan evum Vikriti Vigyan Madan Mohan Malviya Govt Ayurved College, near radaji circle Udaipur.Rajasthan
PIN 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
8949849430 |
| Fax |
|
| Email |
gopalsinghbithu000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Man Mohan Sharma |
| Designation |
Professor & HOD |
| Affiliation |
Madan Mohan Malviya Govt Ayurved College |
| Address |
OPD no.4 PG Department of Rog Nidan evum Vikriti Vigyan Madan Mohan Malviya Govt Ayurved College, near radaji circle Udaipur.Rajasthan
PIN 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9887364809 |
| Fax |
|
| Email |
drmmsharma72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Man Mohan Sharma |
| Designation |
Professor & HOD |
| Affiliation |
Madan Mohan Malviya Govt Ayurved College |
| Address |
OPD no.4 PG Department of Rog Nidan evum Vikriti Vigyan Madan Mohan Malviya Govt Ayurved College, near radaji circle Udaipur.Rajasthan
PIN 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9887364809 |
| Fax |
|
| Email |
drmmsharma72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Govt Ayurved College Udaipur Rajasthan PIN 313001 |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Govt Ayurved College Udaipur |
| Address |
Madan Mohan Malviya Govt Ayurved College, near radaji circle Udaipur.Rajasthan
PIN 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 Gopal Singh Bithu |
Madan Mohan Malviya Govt. Ayurved College Hospital Udaipur |
OPD no.4 PG Department of Rog Nidan evum Vikriti Vigyan Madan Mohan Malviya Govt Ayurved College, near radaji circle Udaipur.Rajasthan
PIN 313001
Udaipur
RAJASTHAN |
8949849430
gopalsinghbithu000@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE M.M.M. GOVT. AYURVED COLLEGE AMBAMATA UDAIPUR (RAJ) |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE M.M.M. GOVT.AYURVED COLLEGE UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E118||Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Triphala-Nimbadi Churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: NIL | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nishamalaki Churna, Reference: Ashtang Hriday Uttar Tantra 40/48 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: Nil |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having clinical signs and symtoms of diabetes mellitus type 2.
2.Patient having fasting blood sugar level between 126-300 mg/dl and post prandial blood sugar level 200-400 mg/dl. |
|
| ExclusionCriteria |
| Details |
1.Patient of type 1 diabetes.
2.Patient with gestational and drug induced diabetes mellitus.
3.Patient with severe systemic diseases and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in signs and symptoms of Madhumeha(Diabetes Mellitus)
2. Lower down of blood sugar level to healthy range. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in signs and symptoms of Madhumeha(Diabetes Mellitus)
2. Lower down of blood sugar level to healthy range. |
20th day , 40th day ,60th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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="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
|
This is a clinical trial to evaluate the comparative therapeutical effect of TRIPHALA-NIMBADI Churna (KALPIT) and NISHAMALAKI Churna in madhumeha (Diabetes mellitus type 2).In this study 20 patient will be administered with TRIPHALA-NIMBADI Churna and other 20 patients will be administered with NISHAMALAKI Churna.Dose of both drug will be 3gm twice a day with lukewarm water after meal. |