| CTRI Number |
CTRI/2025/07/091463 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| 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 how well Panchsam Churna and Vaishvanar Churna work when used with Maharasnadi Kwath in Amvata |
|
Scientific Title of Study
|
A comparative clinical study of
Panchsam Churna and Vaishvanar Churna with Maharasnadi Kwath in Amavata
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranika Singh |
| Designation |
Post Graduate Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan delhi Haridwar Highway 58 Haridwar uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8864846748 |
| Fax |
|
| Email |
singhpranika2805@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubham Sadh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan delhi Haridwar Highway 58 Haridwar uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8792429267 |
| Fax |
|
| Email |
shubhamsadh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Sadh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan delhi Haridwar Highway 58 Haridwar uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8792429267 |
| Fax |
|
| Email |
shubhamsadh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Maharshi Dayanand Gram Delhi-Haridwar National Highway
Uttarakhand 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Maharshi Dayanand Gram Delhi-Haridwar National Highway Uttarakhand 249405 |
| Type of Sponsor |
Private 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 Shubham Sadh |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
OPD NO. 13 and 14 Department of Kayachikitsa Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan delhi Haridwar Highway 58 Haridwar uttarakhand
Hardwar
UTTARANCHAL |
08792429267
shubhamsadh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar (Uttarakhand) |
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 | Drug | Classical | | (1) Medicine Name: Panchsam Churna, Reference: Sharangdhar Samhita Madhyam Khand 6/95-96, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Maharasnadi Kwath), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vaishvanar Churna, Reference: Bhaishajya Ratnawali 29/46-49, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Maharasnadi Kwath), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients with classical features of Amavata like Angmard, Aruchi, Trishna, Aalasya, Gaurava, Jwar, Shotha, Stabdhta.
b. Patients who fullfill the EULAR Classification Criteria for RA with less than 5 years of chronicity.
c. Patients of either sex and socio-economic status with age between 20 and 65 years.
d. Willing and able to participate in the study and ready to sign informed consent form.
|
|
| ExclusionCriteria |
| Details |
1 Patients with uncontrolled Hypertension (more than 160/100 mm of Hg) and diabetes mellitus
2 Patients diagnosed with other types of arthritis like gouty arthritis, tuberculous arthritis etc.
3 Patients with bone deformities like Swan neck deformity, Boutonniere deformity and rheumatic nodules
4 Patients on prolonged medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
5 Patients who have a past history of any major systemic disorder like CA, CRF, Liver cirrhosis, CAD etc.
6 Pregnant and lactating mother.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in Clinical presentation of Amavata assessed through-
1. Change in DAS 28 Score
2. Change in RAPID 3 Score
3. Improvement in Objective Parameters like RA Factor and CRP
4. Change in Subjective Parameters like- Sparshasahyata, Sandhishoth, Gauravata, Aruchi, Jwar, Sandhi shool
|
base line assessment ( day 0)
mid treatment assessment (day 15)
post treatment assessment (day 30)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in quality of life assessed through patient reported feedbackregarding daily activities and overall wellbeing |
base line assessment ( day 0)
mid treatment assessment (day 15)
post treatment assessment (day 30)
|
|
|
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)
|
23/07/2025 |
| 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="1"
Months="6"
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 an open-label, double-arm comparative clinical trial to evaluate the efficacy of Panchsama Churna and Vaishvanar Churna with Maharasnadi Kwath in the management of Amavata (rheumatoid arthritis). A total of 60 patients fulfilling the EULAR criteria for RA will be randomly divided into two groups of 30 each. One group will receive Panchsama Churna with Maharasnadi Kwath, and the other will receive Vaishvanar Churna with Maharasnadi Kwath for 30 days. The efficacy will be assessed based on subjective symptoms like sandhi shool, sandhi jadyata, jwar, sparshasahtya, DAS-28, RAPID-3, RA factor, CRP, grip strength, and foot pressure. Follow-ups will be done on Day 15 and Day 30. The aim is to compare both regimens and provide a cost-effective, safe, and efficient Ayurvedic intervention for Amavata. |