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CTRI Number  CTRI/2024/05/067150 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
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   Effect of Ayurveda Treatment Protocol on Rheumatoid Arthritis 
Scientific Title of Study   Efficacy of Ayurveda Protocol on Rheumatoid Arthritis - A Randomized Controlled Clinical trial 
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 Himanshu Joshi 
Designation  PG Scholar 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003 
Address  Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 India
Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 India
Belgaum
KARNATAKA
590003
India 
Phone  9108699043  
Fax    
Email  joshihimanshu1906@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Basavaraj R Tubaki 
Designation  Professor and HOD 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 
Address  Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 India
Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 India
Belgaum
KARNATAKA
590003
India 
Phone  9448634660  
Fax    
Email  ayurbasavaraj@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR BASAVARAJ R TUBAKI 
Designation  PROFESSOR AND HOD 
Affiliation  KAHERs SHRI BMK AYURVEDA MAHAVIDHYALAYA SHAHPUR BELGAVI KARNATAKA 
Address  KLE SHRI BMK AYURVEDA MAHAVIDYALAYA SHAHPUR BELAGAVI KARNATAKA
KLE SHRI BMK AYURVEDA MAHAVIDYALAYA SHAHPUR BELAGAVI KARNATAKA
Belgaum
KARNATAKA
590003
India 
Phone  08447119161  
Fax    
Email  ayurbasavaraj@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahpur Belgavi 
 
Primary Sponsor  
Name  Dr Himanshu Joshi 
Address  KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahpur Belgavi Karnataka India 
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 Himanshu Joshi  KLE Shri BMK Ayurveda Hospital and Research centre Shahapur Belagavi Karnataka 590003 India  KLE Shri BMK Ayurveda Hospital and Research centre Shahapur Belagavi Karnataka 590003 India Dept of Kayachikitsa OPD no 6 OPD no 7 OPD no 13
Belgaum
KARNATAKA 		 9108699043

joshihimanshu1906@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects Shri BMK Ayurveda Mahavidyalaya and Hospital Shahapur Belagavi 590003  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
1Intervention ArmProcedure-vaitaraNa-bastiH, वैतरण-बस्तिः (Procedure Reference: CHAKRADATTA NIRUHA ADHIKARA 32, Procedure details: SAINDHAVA LAVANA- 1 KARSHA-10gm GUDA- 1 SHUKTI-25gm AMLIKA- 1 PALA-50 gm GOMUTRA-1 KUDAWA-200ml TILATAILA- EESHATMATRA-70 ml.Route-Rectal Dosage form- Kshara, dose-360 ml, Frequency-OD empty stomach Duration- 6 Days Followed by VALUKA SVEDAH for seven days OD after VAITARANA BASTI ANUVASANA BASTI Duration-10 days Medicine- BRIHATSAINDHAVADI TAILAM Reference-Chakradutta 25/48, Route-Rectal, Dosage Form-Taila, Dose-50 ml, Frequency: OD, Duration:10 Days Type-Kala Basti )
(1) Medicine Name: SIMHANADA GUGGULU, Reference: BHAISAJYA RATNAVALI AMAVATA ADHIKARA 130/131, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: tds, Duration: 60 Days
(2) Medicine Name: RASANASAPTAKA KWATH, Reference: BHAISAJYA RATNAVALI 25/8, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: tds, Duration: 60 Days
2Comparator Arm (Non Ayurveda)-METHOTRAXATE SULFASALAZINE HYDROXYCHLOROQUINEMETHOTRAXATE- Dose-7.5mg, Frequency-weekly once ,Route- Oral, Duration-60 Days SULFASALAZINE- Dose-500mg, Frequency-BD, Route- Oral, Duration-60 Days HYDROXYCHLOROQUINE- Dose-200mg, Frequency-BD, Route- Oral, Duration-60 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed as per American college of rheumatoid criteria
Patient fit for basti procedure
Patient fit for valuka sweda procedure 
 
ExclusionCriteria 
Details  Cronicity of more than 10 years
Having severe crippling deformalitypatient with Uncontrolled systemic illness like hypertension diabeties
Pragnent and lactating women
Intra articular corticosteroid injection within 2 month
patient who have participated in any research or on medication for rheumatoid arthritis since 4 months



 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
evaluate the ayurvedic approach to treating rheumatoid arthritis assesed through the DAS 28 scale  baseline and 60th days 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment through American College of Rheumatology Remission & Response criteria 20 50 70
Health Assessment Questionnaire Y Disability Index HAQ DI
CBC ESR CRP RA titre
Quality of Life Short Form Health Survey SF 36
Inflammatory Marker IL 6 		 Assessment through American College of Rheumatology Remission & Response criteria 20 50 70 Baseline 9th 15th 30th 45th 60th day
Health Assessment Questionnaire Y Disability Index HAQ DI Baseline 9th 15th 30th 45th 60th day
CBC ESR CRP RA titre Baseline & 60th day
Quality of Life Short Form Health Survey SF 36 Baseline 9th 15th 30th 45th 60th day
Inflammatory Marker IL 6 Baseline & 60th day
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/06/2024 
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="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 - NO
Brief Summary   Rheumatoid arthritis is a chronic progressive immune inflammatory systemic disease that effect mainly the synovial joint , with a possibility of extra articular manifestations. Rheumatoid is a chronic multisystem disease of unknown cause. It typically starts in small peripheral joints, is usually symetric and progresses to involve proximal joints if left untreated. Untreated rheumatoid arthritis can cause severe damage to the joints and their surrounding tissue. It can lead to heart , lung and nervous system problems. In 2019 , 18 million people worldwide were living with rheumatoid arthritis with female male ratio of 3:1 projected to the whole population this would give a total of about seven million patients in India . The current therapy used to treat rheumatoid arthritis include non steroidal anti inflammatory drugs disease modifyng antirheumatic drugs DMARDS used for a first line therapy for all newly diagnosed cases of rheumatoid arthritis and biological response modifiers, target agents that selectively inhibit specific molecules of the immune system . These medication are similar in their adverse effect so , early and continuous use of DMARDs is necessary to slow joint damage and improve long term outcome .Unfortunately , long term treatment with these drugs is frequently limited the loss of response and/or onset of serious adverse events .
the classical clinical feature of amavata are closely mimic to the features of rheumatoid arthritis .Ama is a the condition in which various ailments in system create toxic effect . The ama when combines with vata dosha and occupies sheleshmasthana (asthisandhi) results in painful disease called amavata . In the management of amavata sequential employment of dipana ,amapachana, shodhan and shaman therapies have been mentioned . various treatment protocol like vaitarana basti , anuvasana basti , valuka sweda with shamana medicines like simhanada guggulu , rasana saptaka kashaya etc. have been mentioned in the classics which are being used to treat the condition. As proved in recent studies bio marker IL-6 was found to be elevated in serum as well as synovial fluid of patients with rheumatoid arthritis hence to know the efficacy of ayurveda treatment on rheumatoid arthritis . This idea as a whole , plan for furthur study is made for the better outcome in patients health .

 
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