| CTRI Number |
CTRI/2020/11/029324 [Registered on: 24/11/2020] Trial Registered Prospectively |
| Last Modified On: |
20/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Rheumatoid Arthritis and its management through Ayurveda |
|
Scientific Title of Study
|
A clinical study of the role of Ashwagandhadi Guggulu and Rasnadwadashak Kwath in the
management of Aamvata W.S.R. to Rheumatoid Arthritis |
| Trial Acronym |
RA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinod Gandharva |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P.G.Department of Kayachikitsa, University
College of Ayurved, Dr Sarvepalli Radhakrishanan Rajasthan
Ayurved University, Karwar, Nagaur Road, Jodhpur
P.G.Department of Kayachikitsa, University
College of Ayurved, Dr Sarvepalli Radhakrishanan Rajasthan
Ayurved University, Karwar, Nagaur Road, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9461199453 |
| Fax |
|
| Email |
vinod.gandharva86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Kumar Mishra |
| Designation |
Associate Professor & HOD |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P.G.Department of Kayachikitsa, University
College of Ayurved, Dr Sarvepalli Radhakrishanan Rajasthan
Ayurved University, Karwar, Nagaur Road, Jodhpur
P.G.Department of Kayachikitsa, University
College of Ayurved, Dr Sarvepalli Radhakrishanan Rajasthan
Ayurved University, Karwar, Nagaur Road, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001009793 |
| Fax |
|
| Email |
drpramodmishra4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Gandharva |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P.G.Department of Kayachikitsa, University
College of Ayurved, Dr Sarvepalli Radhakrishanan Rajasthan
Ayurved University, Karwar, Nagaur Road, Jodhpur
P.G.Department of Kayachikitsa, University
College of Ayurved, Dr Sarvepalli Radhakrishanan Rajasthan
Ayurved University, Karwar, Nagaur Road, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9461199453 |
| Fax |
|
| Email |
vinod.gandharva86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrisanan Rajasthan Ayurved University Jodhpur |
| Address |
P.G.Department of Kayachikitsa, University
College of Ayurved, Dr Sarvepalli Radhakrishanan Rajasthan
Ayurved University, Karwar, Nagaur Road, Jodhpur |
| 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 Pramod Kumar Mishra |
Dr. Sarvepaali Radhakrishanan Rajasthan Ayurved University, University Hospital of Ayurveda |
OPD
No.-3,P.G.Department
of Kaya Chikitsa
DSRRAU Karwar
Nagaur road jodhpur
Jodhpur
RAJASTHAN |
9001009793
drpramodmishra4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwgandhadi Guggulu and Rasnadwadashak Kwath |
Group-A Ashwgandhadi
Guggulu, 3 Vati (Each of 250mg) twice a day orally with lukewarm water for 45 days.
Group-B Rasnadwadashak
Kwath, 40 ml twice a day orally for 45 days.
Group-C Ashwgandhadi
Guggulu, 3 Vati (Each of 250mg) twice a day orally with lukewarm water and Rasnadwadashak Kwath, 40 ml
twice a day orally for 45 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The Patients between the age group of 16 to 60 years in either sex presenting with clinical features of
Aamvata.
2. Pre-diagnosed and confirmed patients of Aamvata (Chronicity <6 years).
3. Patients willing to sign the consent form. |
|
| ExclusionCriteria |
| Details |
1. Patients of age below 16 years and above 60 years of either sex.
2. Chronicity of Aamvata more than 6 years
3. Patients having Neoplasm of spine, Gout, Enclosing spondylitis, Traumatic arthritis and Pyogenic
Osteomyelitis, etc.
4. Patients having any severe disease like Cardiac disease, Pulmonary tuberculosis, Diabetes mellitus,
Renal function impairment, Hypertension etc.
5. Patients with extremely reduced joint space and having bone deformity.
6. Pregnant women and lactating mother. |
|
|
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 in subjective and objective
parameters |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the comparative efficacy of the
treatment in the all groups
|
45 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 |
|
Date of First Enrollment (India)
|
30/11/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aamvata ( Rheumatoid Arthritis) affects about 24.5% million people age of 2015. modern medical science achieved symptomatic relief but consequence is hazardous side effects to reverse or break the pathogenesis of the disease Aamvata. Therefor Ayurveda science may achieve a permanent treatment and root cause of this dangerous disease. The present study is a humble effort to treat the patients of Aamvata (Rheumatoid Arthritis) with Ashwagandhadi Guggulu and Rasnadwadashak Kawth. |