CTRI/2025/02/080464 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On:
25/01/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
ayurvedic treatment of amavata (rheumatoid arthritis)
Scientific Title of Study
AN OPEN-LABEL RANDOMISED CONTROL CLINICAL TRIAL TO ASSESS THE EFFICACY OF PANCHASAMA CHURNA ALONG WITH MAHARASNADI KWATHA AND SIMHANADA GUGGULU IN THE MANAGEMENT OF PAIN IN AMAVATA (RHEUMATOID ARTHRITIS) AFTER VIRECHANA AND IN SILICO EVALUATION OF PANCHASAMA CHURNA
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 Anju S Raj
Designation
PhD Scholar
Affiliation
All India Institute of Ayurveda
Address
All India Institute Of Ayurveda Sarita vihar, New Delhi
Department Of Kayachikitsa
C block,6th floor,612
New Delhi DELHI 110076 India
Phone
08593044787
Fax
Email
anjuthyagaraj@gmail.com
Details of Contact Person Scientific Query
Name
Dr Ramakant Yadava
Designation
Additional professor
Affiliation
All India Institute of Ayurveda
Address
All India Institute Ayurveda, GAUTAMPURI, SARITAVIHAR
Department Of Kayachikitsa
C block ,6th floor All India Institute Ayurveda, GAUTAMPURI, SARITAVIHAR
C block ,6th floor New Delhi DELHI 110076 India
Phone
09412148437
Fax
Email
drrky68@gmail.com
Details of Contact Person Public Query
Name
Dr Anju S Raj
Designation
PhD Scholar
Affiliation
All India Institute of Ayurveda
Address
All india institute of ayurveda Sarita vihar
new delhi
Department Of Kayachikitsa
C BLOCK ,6TH FLOOR ,612
New Delhi DELHI 110076 India
Phone
08593044787
Fax
Email
anjuthyagaraj@gmail.com
Source of Monetary or Material Support
All India Institute of Ayurveda
Sarita Vihar, New Delhi, India
110076
Primary Sponsor
Name
Dr Anju S Raj
Address
All india institute of ayurveda Sarita vihar
new delhi ,110076
C BLOCK ,6TH FLOOR ,612
Type of Sponsor
Research institution
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Anju S Raj
All india institute of ayurveda
C block ,kayachikitsa department ,6th floor , 612 ,Gautampuri,sarita vihar ,110076 New Delhi DELHI
08593044787
anjuthyagaraj@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Division of Translational Research and Biostatistics INSTITUTIONAL ETHICS COMMITTEE
(Procedure Reference: ashtangahridaya, Procedure details: Deepana-Pachana with Ajamodadi churna(Ajamodadi churna-0-3 days)
snehapana with shadpala ghrita
Sarvanga Abhyanga and Sweda with Brihat Saindavadi taila and Dashamoola bashpa sveda
virechana with ichabhedi rasa
Samsarjana Krama: Till Prakrita Agni bala is obtained) (1) Medicine Name: ichabhedi rasa, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: od, Duration: 1 Days
7
Comparator Arm
Procedure
-
virecana-karma, विरेचन-कर्म
(Procedure Reference: ashtangahridaya, Procedure details: Deepana-Pachana with Ajamodadi churna(Ajamodadi churna-0-3 days) snehapana with shadpala ghrita Sarvanga Abhyanga and Sweda with Brihat Saindavadi taila and Dashamoola bashpa sveda virechana with ichabhedi rasa Samsarjana Krama: Till Prakrita Agni bala is obtained))
Inclusion Criteria
Age From
21.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Patients aged 21 to 60 years wishing to participate in the trial with a diagnosis of rheumatoid arthritis.
Includes both seropositive and seronegative cases.
Patients having the clinical manifestation of Amavata (RA) according to Ayurvedic classics -Sandhishool (pain), Shotha (swelling), Sparshasahata (tenderness) and Stabdhata (stiffness),Vrishichikadansavata vedana(pain like scorpion sting), Agnimandya (poor digestion) , Aruchi(anorexia), Gaurav(Feeling of heaviness of body),Utsaha Hani(lack of interest),Mukha vairasya(Perverted taste).
ExclusionCriteria
Details
patients unwilling to participate
pregnant and lactating women
Patients with major complications such as extra-articular manifestations are also excluded.
Patients with other systemic complications of RA like RHD, Rheumatic fever, pleural pericardial disease.
Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis, and psoriatic arthritis.
patients with poorly controlled diabetes and hypertension
patients who is taking medicines for modern ailments
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
• Reduction in Universal pain assessment
baseline,after virechana ,4 weeks after virechana
Secondary Outcome
Outcome
TimePoints
Reduction of RA factor, CRP, ESR
Improvement in DAS 28 score
• To provide relief in the cardinal symptoms of Amavata (RA)
• Improvement in the quality of life of Amavata patients by using SF 36
baseline, 4 weeks after virechana
Target Sample Size
Total Sample Size="132" Sample Size from India="132" 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 2/ Phase 3
Date of First Enrollment (India)
12/03/2025
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="2" Months="0" 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 - YES
What data in particular will be shared? Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
What additional supporting information will be shared? Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
Who will be able to view these files? Response - Anyone
For what types of analyses will this data be available? Response - To achieve aims in the approved proposal.
By what mechanism will data be made available? Response (Others) -
For how long will this data be available start date provided 02-04-2025 and end date provided 02-01-2030? Response - Immediately following publication. No end date.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - nil
Brief Summary
the study is a randomised control clinical trial to assesse the efficacy of Panchasama churna along with Maharasnadi kwatha and Simhanadaguggulu
in the management of pain in Amavata (Rheumatoid arthritis) after Virechana .Primary endpoint will be Reduction in Universal pain assessment. Secondary endpoint will be Reduction
of RA factor, CRP, ESR ,Improvement
in DAS 28 scor , To
provide relief in the cardinal symptoms of Amavata (RA) , Improvement
in the quality of life of Amavata patients by using SF 36. Total partcipant for the trial will be 136 .