| CTRI Number |
CTRI/2026/03/105652 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Dhanyamla Dhara with Erand Bhrishta Haritaki in the Management of Rheumatoid Arthritis |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF DHANYAMLA DHARA WITH ERAND BHRISHTA HARITAKI IN THE MANAGEMENT OF AMAVATA W.S.R TO RHEUMATOID ARTHRITIS
ERAND BHRISHTA HARITAKI IN THE MANAGEMENT OF AMAVATA W S R TO
RHEUMATOID ARTHRITIS |
| 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 DEEPAK SINGH GURJAR |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department of Panchakarma Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan
PG Department of Panchakarma Post Graduate Institute of Ayurved Kadvad Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619086237 |
| Fax |
|
| Email |
deepaksinghgurjar07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Professor & Head of Department Panchakarma |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
Room No 11 PG Department of Panchakarma Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan
Room No 11 PG Department of Panchakarma Post Graduate Institute of Ayurved Kadvad Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Professor & Head of Department Panchakarma |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
Room No 11 PG Department of Panchakarma Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan
Room No 11 PG Department of Panchakarma Post Graduate Institute of Ayurved Kadvad Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 342037 Rajsthan India |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Panchakarma Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan |
| 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 DEEPAK SINGH GURJAR |
Post Graduate Institute of Ayurved |
Room no 11 PG department of panchkarma Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 342037 Rajsthan India
Jodhpur
RAJASTHAN |
8619086237
deepaksinghgurjar07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittee post graduate institute of ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | dravasvedaH, द्रवस्वेदः | (Procedure Reference: shastar yoga, Procedure details: PoorvaKarma Patient should sit lie down on the droni talam should be kept on head Then an
eye pad should be tied around the head & ear should be plugged with cotton
Pradhana Karma Dhanyamla should be heated indirectly & poured in the dhara pot & two
attended standing on both sides of the droni pour the dhanyamla in medium speed from 12 angula
height Everyday fresh Dhanyamla is used
Total duration 16 days (Per day 45 minute)
Pashchat Karma After dhara entire body is cleaned using soft towel Patient is asked to rest for
some time as procedure & then asked to take bath with warm water)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Patients of either sex with age between 20 and 60 years
Willing and able to participate in the study
Patient having signs & symptoms of Amavata w s r Rheumatoid arthritis with fulfilling Diagnostic
criteria
Chronicity less than 10 years
Patients with postchikungunya Rheumatoid arthritis will be included if fulfilling ACR diagnostic
criteria
To be fit&willing for treatment |
|
| ExclusionCriteria |
| Details |
Patients having severe systemic diseases like cardiac disorders and Cancer
Patients below 20 years and above 60 years
Chronicity 10 or more years
Patient not fit for Dhanyamla Dhara in respective group
Patients having Gouty arthritis Osteo arthritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Dhanyamla Dhara with Erand Bhrishta Haritaki in Amavata
To asses changes in symptoms of Amavata
|
16 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To improve the quality of life
|
16 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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="0"
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
|
This study is an open label interventional clinical trial designed to evaluate the efficacy of Dhanyamla Dhara with Erand Bhrishta Haritaki in the management of Amavata with special reference to Rheumatoid Arthritis. A total of 30 patients of either sex aged between 20 to 60 years fulfilling diagnostic criteria of Amavata and Rheumatoid Arthritis will be selected from OPD and IPD The intervention includes Dhanyamla Dhara performed daily for 45 minutes for 16 days along with oral administration of Erand Bhrishta Haritaki 6 grams at bedtime with lukewarm water The study follows a single group pre and post design. Assessment will be done based on subjective Ayurvedic parameters such as joint pain swelling stiffness and associated symptoms and objective parameters including RA factor ESR and CRP before treatment after treatment and after follow up The primary objective is to assess the efficacy of the intervention in reducing symptoms of Amavata while the secondary objective is to improve quality of life The collected data will be statistically analyzed to evaluate the outcome of the therapy |