FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/082419 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 09/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical trial to study the effect of Erandbeejadi vati in Rheumatoid Arhtritis(Amavata) 
Scientific Title of Study   A Single Arm Clinical Study To Evalute The Efficacy Of Erandbeejadi Vati In The Management of Amavata With Special Reference To Rheumatoid Arthritis.  
Trial Acronym  RA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anilkumar 
Designation  pg scholar 
Affiliation  Kunwar shekhar vijendra ayurved medical college and research centre gangoh 
Address  Department of kayachikitsa kunwar shekhar vijendra ayurved medical college and research centre, Adarsh institutional area babu vijendra marg gangoh.

Saharanpur
UTTAR PRADESH
247341
India 
Phone  09406668409  
Fax    
Email  anilkumar011m@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bandana dhall 
Designation  professor 
Affiliation  Kunwar shekhar vijendra ayurved medical college and research centre gangoh 
Address  Department of kayachikitsa kunwar shekhar vijendra ayurved medical college and research centre, Adarsh institutional area babu vijendra marg gangoh.

Saharanpur
UTTAR PRADESH
247341
India 
Phone  9348061460  
Fax    
Email  bandanadhall1981@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bandana dhall 
Designation  professor 
Affiliation  Kunwar shekhar vijendra ayurved medical college and research centre gangoh 
Address  Department of kayachikitsa kunwar shekhar vijendra ayurved medical college and research centre, Adarsh institutional area babu vijendra marg gangoh.

Saharanpur
UTTAR PRADESH
247341
India 
Phone  9348061460  
Fax    
Email  bandanadhall1981@gmail.com  
 
Source of Monetary or Material Support  
Department of kayachikitsa Kunwar shekhar vijendra ayurved medical college and research centre,babu vijendra marg,Gangoh,distt-Saharanpur,pincode-247341 Uttar Pradesh,India 
 
Primary Sponsor  
Name  self 
Address  Adarsh Institutional Area,Babu Vijendra marg Gangoh,Distt-Saharanpur,Pincode-247341(UP)India. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nill   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anil kumar  Department of kayachikitsa First floor K.S.V.A.Medical college And Research Centre   Adarsh Institutional Area Babu Vijendra marg Gangoh Distt-Saharanpur,Pincode-247341(UP)India.
Saharanpur
UTTAR PRADESH 		 09406668409

anilkumar011m@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KSVAMC-IEC/SUIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Erandbeejadi vati, Reference: Yogratnakar 28/64, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshnajal), Additional Information: -The assessment of the patient was done at the interval of 15days 30 days 45 days and the followup was done two month after completion of treatment.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1-Subjects willing to sign the consent forms. 2-Subjects in the age group between 20-70 year. 3-Either sex. 4-New cases of RA. 5-Subjects having sandhishool,sandhishoth,sandhistsbdhata,sparshaasahatva and associated lakshnas of amavata. 6-Chronicity should be less than 3 year. 
 
ExclusionCriteria 
Details  1-Subject on standard treatment. 2-Subjects in the age group of less than 20 years and more than70 year will not be included for the present study.
3-Subjects having major illness and prediagnosed of Hypertension,HIV,Diabetes mellitus,Rheumatic fever were excluded from the study. 4-Deformity like swan neck,Boutonniere,Hitchhiker. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in sign and symptoms of Rheumatoid arthritis.  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
1-Cost effective treatment. 2-To observe if there any side effect.  45 days 
 
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 3 
Date of First Enrollment (India)   24/03/2025 
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="1"
Months="6"
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   1-The  volunteer will be informed about the study protocol.                                                                                                                                                                                                                                                                                    2- Willing participant will be randomly selected as per computer generated table.                                                                                                                                                                                                                                                3- The clinical research format will be validated.                                                                                                                                                                                                                                                                                                      4-Single  centre,open labelled,Randomized,Interventional study.                                                                                                                                                                                                                                                                            5-comparing the safety and efficacy of Erandbeejadi vati in amavata.                                                                                                                                                                                                                                                                    6-Subjects are selected randomly computerised method on the basis of inclusion criteria.                                                                                                                                                                                                                                    7-Drugs are given to subjects in parallel group of40 patients. 
Close