| CTRI Number |
CTRI/2026/03/106980 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess the Effect of a Selected Ayurvedic Treatment Protocol in Disease Activity of Rheumatoid Arthritis.(participants satisfying revised ACR/EULAR criteria for Rheumatoid Arthritis) |
|
Scientific Title of Study
|
Effect of a Selected Ayurvedic Treatment Protocol in Disease Activity of 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 |
B Sreerekha Pillai |
| Designation |
Second Year PG Scholar |
| Affiliation |
Government Ayurveda College,Thiruvananthapuram |
| Address |
Department of Kayachikitsa
Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9072082109 |
| Fax |
|
| Email |
pillaisreerekhapillai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravith N K |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department Of Kayachikitsa
Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946431132 |
| Fax |
|
| Email |
drnkpravith@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravith N K |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department Of Kayachikitsa
Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946431132 |
| Fax |
|
| Email |
drnkpravith@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Thiruvananthapuram
695001 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College |
| Address |
Government Ayurveda College Thiruvananthapuram Kerala PIN 695001 |
| Type of Sponsor |
Other [Government Ayurveda 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 |
| B Sreerekha Pillai |
Government Ayurveda College Thiruvananthapuram |
OP No 2
Department of Kayachikitsa Government Ayurveda College Thiruvananthapuram PIN 695001
Thiruvananthapuram
KERALA |
9072082109
pillaisreerekhapillai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Government Ayurveda College Thiruvananthapuram Kerala PIN 695001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M95-M95||Other disorders of the musculoskeletal system and connective tissue. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amruthotharam Kashayam, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -sarkara), Additional Information: -(2) Medicine Name: Shaddharana churna, Reference: Susrutha Samhitha Chikitsasthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -Kashayam), Additional Information: -(3) Medicine Name: Kolakulathadi churna, Reference: Charaka Samhitha Sutrasthana, Route: Topical, Dosage Form: Churna/ Powder, Dose: 300(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (4) Medicine Name: 7 Days, Reference: No, Route: -, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (5) Medicine Name: Indukantha Ghritam, Reference: Sahasrayogam, Route: Oral, Dosage Form: Ghrita, Dose: 15(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Hotwater), Additional Information: -dose will be increased according to agnibala and koshta of patient(6) Medicine Name: Chinchadi Tailam, Reference: Sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (7) Medicine Name: 3 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (8) Medicine Name: , Reference: Gandharva Eranda Tailam, Route: Ashtanga Samgraha,Chikitsasthana, Dosage Form: Taila, Dose: 31(25), Frequency: ml, Bhaishajya Kal: od, Duration: Abhakta, anupAna/sahapAna: No, Additional Information: -Hotwater |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Identified with revised ACR/EULAR criteria for Rheumatoid Arthritis |
|
| ExclusionCriteria |
| Details |
Who are known case of uncontrolled systemic hypertension,cardiovascular diseases,extraarticular complications of RA,pregnant and lactating women,crp greater than 50mg/L |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce disease activity of Rheumatoid Arthritis |
Baseline,end point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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
|
N/A |
|
Date of First Enrollment (India)
|
08/04/2026 |
| 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="6"
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
|
The above study deals with assessing the effect of a selected ayurvedic treatment protocol in disease activity of rheumatoid arthritis . It is a interventional single arm pre post study design .Evaluation is made on the changes in DAS 28 score |