| CTRI Number |
CTRI/2025/11/097250 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study on the Effect of Punarnavadi Churna Aabhadhya Churna and Shatpushpadi Lepa in Rheumatoid Arthritis |
|
Scientific Title of Study
|
A Comparative Clinical study to evaluate the efficacy of Punarnavadi Churna Aabhadhya Churna & Shatpushpadi Lepa In The Management of Amavata With Refernce 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 Varsha Paikra |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur C.G. |
| Address |
Department of Kayachikitsa OPD No 2 and 20 Shri Khudadad Dungaji Goverment Ayurved Hospital Raipur Chhattisgarh 492010 India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9111849706 |
| Fax |
|
| Email |
paikravarsha69@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Ojha |
| Designation |
Professor and HOD Department of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh |
| Address |
Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9424401858 |
| Fax |
|
| Email |
arunaojha90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aradhana Kande |
| Designation |
Assistant Professor |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh |
| Address |
Department of Roga Nidan Evum Vikriti Vigyan Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010 India
Raipur
CHHATTISGARH
492010
India |
| Phone |
7999482523 |
| Fax |
|
| Email |
draradhanasharmakande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurved College Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurved College Raipur chhattisgarh |
| Address |
Shri Narayan Prasad Awasthi Govt Ayurved College Raipur chhattisgarh 492010 |
| 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 Varsha Paikra |
Shri Khudadad Dunga ji Government Ayurved Hospital Raipur Chhattisgarh 492010 |
OPD NO.2 & 20 Department Of Kayachikitsa Shri Khudadad Dunga ji Government Ayurved Hospital Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH |
9111849706
paikravarsha69@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVED COLLEGE RAIPUR |
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: Punarnavadi Churna, Reference: Bhavprakash Madhyam Khand 26/46-47, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Ushna Jal), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aabhadhya Churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Ushna jal), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatpushapadi Lepa, Reference: Bhaishajya Ratnavali 29/9-10, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Kanji), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with symptoms of Aamvata as mentioned in ayurvedic text
Patients suffering from rheumatism as modern standard
Male and female patients irrespective of gender caste and religion |
|
| ExclusionCriteria |
| Details |
Blood disorders
Serious heart diseases
Cancer patients
Chronic stage of diabetes
Pregnant and lactating women
Chronic kideny diseases
7.patients takind DMARD and steroid
8.Incase of gout, arthritis and any kind of infection in the joints |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the symptoms of Aamvata |
Intervention treatment will be given for 2 months at every 15th days interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve the quality of life |
Intervention treatment will be given for 2 months at every 15th days interval |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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="2"
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
|
Amavata is a significant disease described in ayurveda This disease is usually caused by agni dusti which results in the production of Ama Amavata is a chronic painful disorder caused by the vitiation of Vata dosha and accumulation of Ama closely resembling Rheumatoid Arthritis in modern medicine It manifests with symptoms such as joint pain swelling stiffness fever and reduced mobility
This comparative clinical study aims to assess and compare the therapeutic efficacy of three Ayurvedic formulations Punarnavadi Churna Aabhadhya Churna and Shatpushapadi Lepa in the management of Amavata Punarnavadi Churna is known for its Amapachana Shothahara and Vata-kapha hara properties Aabhadhya Churna possesses Deepana Pachana and Vatanulomana actions helping in digestive correction and toxin elimination Shatpushapadi Lepa, an external application, aids in local relief by reducing inflammation swelling and pain The study involves patients diagnosed with Amavata/ Rheumatoid Arthritis divided into three groups. Assessment criteria include Sandhi Shula Sandhi Shotha Sandhi Stambha along with relevant laboratory parameters All three formulations are expected to show significant improvement in signs and symptoms of Amavata but the comparative analysis will help determine which combination provides the most effective relief in symptoms, functional recovery The study aims to establish a safe, natural, and holistic Ayurvedic approach for managing Rheumatoid Arthritis |