| CTRI Number |
CTRI/2025/06/088364 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the Effectiveness of Kala Basti and Karpasasthyadi Pinda Swedana with Nagar Churna in the Management of Rheumatoid Arthritis (Aamvata) |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Kala Basti Along with Karpasasthyadi Pinda Swedan Followed by Nagar Churna in the Management of Aamvata (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 Prem Kumari Choudhary |
| 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
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7073938085 |
| Fax |
|
| Email |
prempramod9887@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate 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
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate 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
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 Rajasthan INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Panchakarma Post Graduate Institute of Ayurved
DSRRAU Jodhpur 342037 Rajasthan INDIA |
| 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 PREM KUMARI CHOUDHARY |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
PG Department of
Panchakarma Post
Graduate Institute of
Ayurved Dr Sarvepalli
Radhakrishnan
Rajasthan Ayurved
University Jodhpur
Nagaur Road Kadvad
Jodhpur
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
7073938085
prempramod9887@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | piNDasvedaH, पिण्डस्वेदः | (Procedure Reference: bhai. ratnavali, Procedure details: Medicated boluses prepared from equal parts of Karpasasthi, Kulathha, Tila, Yava, Eranda, Atasi, Punarnava, and Shana—processed with Kanji—will be steam-heated and applied over affected joints for 7–15 minutes daily. Temperature will be checked prior to application to ensure patient safety)
(1) Medicine Name: Karpasasthi, Reference: bhai. ratnavali, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: od, Duration: 16 Days | | 2 | Intervention Arm | Procedure | - | kAla-bastiH, काल-बस्तिः | (Procedure Reference: chaktadatt, Procedure details: Kala Basti will be administered for 16 days with a schedule of 9 Anuvasana Basti (Eranda Taila 60 ml) and 7 Niruha (Churna Basti 450 ml) in alternate manner as per classical texts. Procedure includes Purva Karma (Abhyanga & Swedana), Pradhana Karma (rectal administration of basti in left lateral position), and Paschat Karma (rest, monitoring, and post-care).)
(1) Medicine Name: churn basti, Reference: chaktadatt, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 450(ml), Frequency: od, Duration: 16 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex aged 18 to 60 years
Willing and able to participate in the study
Diagnosed Amavata patients as per Ayurveda and 1987 ACR criteria for RA
Chronicity less than 5 years
Post chikungunya RA cases included if meeting diagnostic criteria |
|
| ExclusionCriteria |
| Details |
Patients with severe systemic diseases like cardiac disorders or cancer
Patients below 18 years or above 60 years
Pregnant or lactating women
Chronicity more than 5 years
Patients with gouty arthritis or osteoarthritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Kala Basti along with Karpasasthyadi Pinda Sweda followed by Nagar Churna on subjective and objective parameters of Amavata |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome includes observing any
other effects of the drug & procedure, such as
changes in inflammation, patient satisfaction,
reduction in the need for conventional
medications, & overall quality of life
improvements |
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)
|
01/01/2026 |
| 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 clinical study aims to evaluate the efficacy of Kala Basti along with Karpasasthyadi Pinda Sweda followed by Nagar Churna in the management of Amavata Rheumatoid Arthritis A total of 30 patients fulfilling inclusion criteria will be enrolled from OPD IPD of DSRRAU Jodhpur The intervention includes 16 days of Kala Basti and Pinda Sweda followed by oral administration of Nagar Churna for 15 days Assessment will be based on Ayurvedic and modern clinical parameters including DAS28 RA factor ESR and CRP levels The goal is to assess improvement in joint pain swelling stiffness and overall quality of life |