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CTRI Number  CTRI/2023/06/053786 [Registered on: 12/06/2023] Trial Registered Prospectively
Last Modified On: 07/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical study of enema with Medicated decoction & Modern treatment regime in the management of joint pain. 
Scientific Title of Study   A Comparative Clinical study on Erandathi Kwatha with Vaitarana vasti & Modern treatment regime in the management of Amavata(Rheumatoid arthritis) with special reference to Gut microbiota 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSowmiyaV 
Designation  M.D(Ay)Scholar 
Affiliation  Banaras Hindu University 
Address  Department of Kayachikitsa Faculty of Ayurveda Institute of Medical sciences Banaras Hindu university Varanasi - 221005 Varanasi UTTAR PRADESH 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  8110843244  
Fax    
Email  sowmiya.9796@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof OP Singh 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Department of Kayachikitsa Faculty of Ayurveda Institute of Medical sciences Banaras Hindu university Varanasi - 221005 Varanasi UTTAR PRADESH 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415818732  
Fax    
Email  singhopbhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof OP Singh 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Department of Kayachikitsa Faculty of Ayurveda Institute of Medical sciences Banaras Hindu university Varanasi - 221005 Varanasi UTTAR PRADESH 221005 India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415818732  
Fax    
Email  singhopbhu@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Science Banaras Hindu University 
 
Primary Sponsor  
Name  Department of Kayachikitsa Faculty of Ayurveda IMS BHU 
Address  Department of Kayachikitsa, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University. Varanasi- 221005 
Type of Sponsor  Research institution and hospital 
 
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 
Prof O P Singh  Sir Sunderlal Hospital BHU  OPD No.21,22 Indian Medicine Wing Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences BHU Varanasi
Varanasi
UTTAR PRADESH 		 9415818732

singhopbhu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M200||Deformity of finger(s). Ayurveda Condition: AMAVATAH, (2) ICD-10 Condition:M20-M25||Other joint disorders. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-1.Tab. Rabeprazole , 2.Prednisolone, 3. tab Methotrexate 4. Tab folic acid.Tab. Rabeprazole 20 mg 1 OD Before food for 10 days 2.Tab. Prednisolone 10 mg 1BD after food for 10 days 3.Tab. Methotrexate 15 mg once a week, to be continued 4.Tab. Folic acid 5 mg one tablet once a week( on the next of taking methotrexate) to be continued.
2Intervention ArmProcedure-vaitaraNa-bastiH, वैतरण-बस्तिः (Procedure Reference: chakradutta vastikarma adhikara, Procedure details: Vaitarana Vasti will be done for 7 days in every month )
(1) Medicine Name: Erandathi kwatha, Reference: chakradutta chikitsa sthana 25 chapter, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 3 Months
3Intervention ArmDrugClassical(1) Medicine Name: Erandathi kwatha, Reference: chakradutta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients aged between 16 – 60 years age.
2.Diagnosed cases of Amavata/RA based on symptoms and signs described in Madava Nidana & ACR 2010
3.Patients with H/O more than 1 year with established disease.
4.Sero positive and sero negative both cases are included. 
 
ExclusionCriteria 
Details  1.Patients below the age of 16 and above 60 years of age
2.Patients suffering from systemic disorders (like Diabetes Mellitus, Cardiac diseases, Pulmonary Tuberculosis, Essential Hypertension, SLE, Infectious Arthritis, Hypertrophic Arthropathy)
3.Pregnant & Lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in Sandhisoola
Sandhisotha
Sandhigraha
Sparsahatwa & Jwara 		 Three months with monthly follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of-
1 Laboratory parameters
2 X ray of joints
3 Stool with culture & sensitivity for Gut microbiota 		 Three months with monthly follow up 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   01/07/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Rheumatoid arthritis is the most common chronic, immune -inflammatory systemic disease. In india the prevalence of RA is 0.65% -0.75% according to API. Although the etiology and pathogenesis of RA is not clear but its presumed that autoimmunity plays a significant role in the genesis of disease, Chronicity and progression of RA. The conventional medical management is always challenged by the poor response, adverse effects, invasive complications. in this study, will evaluate the importance of anti-rheumatic drug induced host microbiota modulations and possible probiotics that can generate eubiosis. The present clinical study aim to assess clinically the efficacy of Erandathi Kwatha with Vaitharana vasti and Modern treatment regime in the management of Amavata(RA) with special reference to Gut microbiota. There will be 3 month duration with monthly follow up with medication. Assessment will be done on the basis of prepared proforma for subjective and objective parameters. 
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