| CTRI Number |
CTRI/2023/05/052849 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Kiratatikta Churna in the management of Amavata(Rheumatoid Arthritis) |
|
Scientific Title of Study
|
A Clinico-Etiopathological Study to evaluate the efficacy of Kiratatikta Churna in the management of Amavata - A Single arm clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Sharma |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh , New Delhi-110073 |
| Address |
PG Department of Rog Nidan Evum Vikruti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar
South West
DELHI
110073
India |
| Phone |
|
| Fax |
|
| Email |
aku.sharma1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vidula Gujjarwar |
| Designation |
Professor and HOD |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh , New Delhi-110073 |
| Address |
PG Department of Rog Nidan Evum Vikruti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar
South West
DELHI
110073
India |
| Phone |
|
| Fax |
|
| Email |
Shreemahalaxmi1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Vidula Gujjarwar |
| Designation |
Professor and HOD |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh , New Delhi-110073 |
| Address |
PG Department of Rog Nidan Evum Vikruti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar
South West
DELHI
110073
India |
| Phone |
|
| Fax |
|
| Email |
Shreemahalaxmi1969@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan |
|
|
Primary Sponsor
|
| Name |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi - 110073 |
| 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 Akanksha Sharma |
Ch. Brahm Prakash Ayurved Charak Sansthan |
Rog Nidan Evum Vikruti Vigyan Department, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, South West Delhi, New Delhi 110073
South West
DELHI |
9717496469
aku.sharma1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - CBPACS |
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 | Other than Classical | | (1) Medicine Name: Kiratatikta , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed Patients Of Rheumatoid Arthritis as per 2010 ACR/ EULAR Criteria
Patients having Samanyalakshana and Pravridhhalakshana of Amavata as per Madhavnidana
Patients willing to give consent for the study |
|
| ExclusionCriteria |
| Details |
Pregnant women and Lactating mothers
All other forms of Arthritis
Patients having co morbidities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in VAS score and DAS28 Score is expected and will be assessed on 0, 15th, 30th and 45th day. |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will provide cost effective, safe drug with lesser side effects |
6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/06/2023 |
| Date of Study Completion (India) |
20/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/12/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Amavata has been described as the disease having highest incurable tendency among all the disease as acharaya madhavkar says ( sa kashtah sarva roganaam yada prakupito bhaveta).
Amavata is a systemic disease where along with articular symptoms, manifestation of Gastrointestinal, cardiac and renal disturbances are also evident.Gastrointestinal changes are primary pathological factor for the development of this disease.
Rheumatoid arthritis is a autoimmune musculo-skeletal disorder, which leads to irreversible joint damage and systemic complication as explained in modern medicine
Ama is only responsible for the production of multiple symptoms and due to this ama the disease is considered difficult to treat as mentioned by acharaya madhavkar ( vyadhinam ashryo hi eshaam amasangyoatidarunaah).
The present study is aimed to find out the efficacy of Kiratatikta churna in the management of Amavata.
Study type is interventional and the study design is single arm clinical trial with sample size of 50 patients.
Kiratatikta churna will be given in the dose of 3gm with Ushnodaka , twice daily , after meal for 45 days.
This study is expected to be beneficial in the management of Amavata.
|