| CTRI Number |
CTRI/2024/08/072714 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Indravaruni Yog and Aabhaadi Churna in Osteoarthritis |
|
Scientific Title of Study
|
An Etiopathological Study of Sandhigata Vata w.s.r.to Osteoarthritis and Comparative Therapeutical Trial of Indravaruni Yog and Aabhaadi 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 Keshav Asiwal |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
PG Department of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College,near Radaji
circle, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7976891870 |
| Fax |
|
| Email |
Keshavkumawat432@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Man Mohan Sharma |
| Designation |
Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved COllege |
| Address |
PG Department of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College,near Radaji
circle, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8426050055 |
| Fax |
|
| Email |
drmmsharma72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Man Mohan Sharma |
| Designation |
Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved COllege |
| Address |
PG Department of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College,near Radaji
circle, Udaipur
RAJASTHAN
313001
India |
| Phone |
8426050055 |
| Fax |
|
| Email |
drmmsharma72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madn Mohan Malviya Government Ayurved College, Radaji Circle Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College |
| Address |
Madan Mohan Malviya Government Ayurved College Radaji Circle
,Udaipur 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 Keshav Asiwal |
Madan Mohan Malviya Government Ayurved College |
OPD No. 4 PG Department Of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College Radaji Circle
,Udaipur Pin Code- 313001
Udaipur
RAJASTHAN |
7976891870
Keshavkumawat432@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee madan mohan malviya govt. ayurved college udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M190||Primary osteoarthritis of other joints. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Indravaruni yog, Reference: Ras Ratna Samuchchay 21/166, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: 5 gm Guda), Additional Information: Nil(2) Medicine Name: Aabhaadi Churna, Reference: Yog ratnakar Vatvyadhi , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: Nil |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The Patients having Clinical Sign and Symptoms of Osteoarthritis |
|
| ExclusionCriteria |
| Details |
Other Disease such as Paralysis, Parkinsan Disease, Anaemia And Cancer patients |
|
|
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 |
| Improvement of Sign And Symptoms of (Sandhigata Bata )Osteoarthritis |
2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of Sign And Symptoms of (Sandhigata vata )Osteoarthritis |
4 Weeks |
|
|
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)
|
19/11/2024 |
| 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="0"
Days="30" |
|
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 trail to evaluate the Therapeutic effect of Indravaruni Yog and Aabhaadi Churna in Sandhigata bata(Osteoarthritis). It is a Parallels Comparative study 40 Patients will be administered with 2 Gm of Indravaruni Yog Churna with 5 gm Guda and 6gm of Aabhaadi Churna with Lukewarm water Twice a day. |