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CTRI Number  CTRI/2024/11/076777 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management Of Multiple Joint Pain, stiffness, swelling By Chaturbhadra Kalpa Basti And Yoga Basti.  
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Efficacy Of Chaturbhadra Kalpa Basti And Yoga Basti In The Management Of Amavata (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 Naitik Tanmay Gopiani 
Designation  PG Scholar 
Affiliation  G. J. Patel Institute Of Ayurvedic Studies And Research 
Address  Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120.

Anand
GUJARAT
388120
India 
Phone  7984788098  
Fax    
Email  naitikgopiani1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suma K J 
Designation  Associate Professor 
Affiliation  G. J. Patel Institute Of Ayurvedic Studies And Research 
Address  Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120.

Anand
GUJARAT
388120
India 
Phone  9742786607  
Fax    
Email  sumakumble@outlook.com  
 
Details of Contact Person
Public Query  
Name  Dr Suma K J 
Designation  Associate Professor 
Affiliation  G. J. Patel Institute Of Ayurvedic Studies And Research 
Address  Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120.

Anand
GUJARAT
388120
India 
Phone  9742786607  
Fax    
Email  sumakumble@outlook.com  
 
Source of Monetary or Material Support  
S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120 
 
Primary Sponsor  
Name  Dr. Naitik Tanmay Gopiani 
Address  Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120. 
Type of Sponsor  Other [Self] 
 
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 Naitik Tanmay Gopiani  S. G. Patel Ayurveda Hospital And Maternity Home  Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120.
Anand
GUJARAT 		 7984788098

naitikgopiani1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
G.J.Patel Institute Of Ayurvedic Studies And Research & S.G.Patel Ayurveda Hospital & Maternity Home Institutional (Human) Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-yoga-bastiH, योग-बस्तिः (Procedure Reference: Kashyapa Samhita, Procedure details: (Procedure Reference: Kashyapa Samhita , Procedure details: Yoga Basti for 8 days. For first 6 days Anuvasana Basti & Niruha Basti on alternative days starting with Anuvasana Basti. On last 2 days continuous Anuvasana basti. Anuvasana Basti with Brihat Saindhavadi Taila 120 ml immediately after food. Vaitarana Basti as Niruha Basti 320 ml before food. Vaitarna Basti Ingredients- Amlika - 48 gm, Guda - 24 gm, Saindhava Lavana - 12 gm, Gomutra - 192 ml, Brihat Saindhavadi Taila - 44 ml.))
(1) Medicine Name: Brihat Saindhavadi Taila, Reference: Chakradatta, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 08 Days
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Kashyapa Samhita, Procedure details: (Procedure Reference: Kashyapa Samhita, Procedure details: Chaturbhadra Kalpa Basti for 12 days. First four days continuous Anuvasana Basti, then four days continuous Niruha Basti & then four days continuous Anuvasana Basti. Anuvasana Basti with Brihat Saindhavadi Taila 120 ml Immediately after food. Vaitarana Basti as Niruha Basti 320 ml before food. Vaitarana Basti ingredients- Amlika (48 gm), Guda (24 gm), Saindhava Lavana (12 gm), Gomutra (192 ml), Brihat Saindhavadi Taila (44 ml) )
(1) Medicine Name: Brihat Saindhavadi Taila, Reference: Chakradatta, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 12 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Participants fulfilling diagnostic criteria.
2) Participants fulfilling 2010 ACR EULAR classification criteria for Rheumatoid Arthritis.
3) Participants of either Gender and age between 30 to 60 years.
4) Participants fit for Anuvasana and Niruha Basti karma. 
 
ExclusionCriteria 
Details  1) Participants are not fit for Anuvasana and/or Niruha Basti as per Ayurvedic classics.
2) Participants with major systemic illnesses.
3) Those who have undergone surgical treatment in affected joints.
4) Participants who report any untoward symptoms during the period of study.
5) Participants on steroids or were on steroid before 6 months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
VAS scale, ROM by Goniometer, Anthropometric measurement of big joints by measuring tape & Jeweler’s ring sizer measurement for small joints.
ESR, CRP (Quantitative).
 		 For Group A 0th, 12th, 19th and 26th days.
For Group B 0th, 8th, 15th and 22nd days. 
 
Secondary Outcome  
Outcome  TimePoints 
Sandhishula (pain in joints), Sandhistabdhata (stiffness in joints), Sandhisotha (swelling in joints), Restriction of movements, Angamarda (body ache), Aruci (tastelessness), Trsna (polydipsia), Alasya (malaise), Gaurava (feeling of heaviness), Jwara (fever), Apaka (indigestion), Sunata-anganam (swelling).
 		 For Group A 0th, 12th, 19th and 26th days.
For Group B 0th, 8th, 15th and 22nd 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)   12/12/2024 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

“Amena sahita vata Amavata”.

The virulent ama circulates in the whole body propelled by the vitiated Vata dosha producing blockage in the body channels (srotorodha) that takes ashraya in the Sandhi giving rise to Amavata. Amavata is a disease of Rasavaha Srotas affecting abhyantara and madhyama roga marga, as it involves Marma, Asthi and Sandhi.

Rheumatoid Arthritis is an inflammatory autoimmune disease which causes swelling, pain, stiffness in multiple joints but most commonly in small joinys of hands and feet, knee, elbow, wrists etc.

The typical onset of the disease occurs in adult in their sixties. Women are two to three times more often affected than men. In 2019, 18 million people worldwide were living with Rheumatoid Arthritis. About 70% of people living with Rheumatoid Arthritis are women and 55% are older than 55 years. 13 million people with Rheumatoid Arthritis experience severity of moderate or severe level that could be benefitted from rehabilitation. RA affects about 0.24 to 1 percent of the global population while in India its about 0.75 percent of the population.

Early diagnosis and management can reduce symptoms, slow the disease and prevent disability. Contemporary medicine includes NSAIDS, DMARD’s, Immunosuppressants, steroids and some surgical procedures etc. Despite of all that chances of recurrence is more. But with Ayurveda treatment recurrence can be decrease as it effects the root causes not just symptoms and specially Basti chikitsa is labelled as Ardha Chikitsa for Vata vyadhi. With the Basti along with other oral treatment and pathya ahara-vihara, deformities can be prevented, so person can improve their quality of life by performing daily routine activities easily.

Acharya Kashyapa has explained a different krama of four continuous Anuvasana (unctuous) Basti in the beginning and at the end, four continuous Niruha Basti (cleansing) in between, is known as Chaturbhadra Kalpa Basti and it is free from complications. Yoga Basti is used when Vata does not have good strength and is associated with Kapha. In Yoga Basti, 3 Niruha Basti and 5 Anuvasana Basti by most of the Acharya.

For Group A- Chaturbhadra Kalpa Basti for 12 days

For Group B- Yoga Basti for 8 days

Anuvasana-  Brihat Saindhavadi Taila- 120 ml- Immediately after food

Niruha Basti – Vaitarana Basti- 320 ml- before food

After completion of treatment and follow up as a result expecting decrease in joint pain, stiffness, swelling, etc. and increase range of movement as well.

 
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