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CTRI Number  CTRI/2024/05/067141 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Curative]  
Study Design  Single Arm Study 
Public Title of Study   Effect of virechana karma with Gandharvahastadi kwath in the management of Aamvat w.s.r. to rheumatoid arthritis  
Scientific Title of Study   A clinical study on the effect of virechana karma with Gandharvahastadi kwath in the management of Aamvat w.s.r. to 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.Suman Lata 
Designation  Md (AY.) scholar, Panchakarma  
Affiliation  Government Ayurvedic College and hospital  
Address  Government Ayurvedic College and Hospital, Kadamkuan,Patna.
Government Ayurvedic College and Hospital, Kadamkuan, Patna 800003,Bihar
Patna
BIHAR
800003
India 
Phone  7635044262  
Fax  -  
Email  slatasuman159@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akhilesh Prasad Singh 
Designation  H.O.D & Associate Professor  
Affiliation  Government Ayurvedic College and Hospital  
Address  Department of Panchakarma Government Ayurvedic College and Hospital, Kadamkuan, Patna
Department of Panchakarma Government Ayurvedic College and Hospital, Kadamkuan ,Patna 800003,Bihar
Patna
BIHAR
800003
India 
Phone  8002680973  
Fax  -  
Email  drapsinghpatna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akhilesh Prasad Singh 
Designation  H.O.D & Associate Professor  
Affiliation  Government Ayurvedic College and Hospital  
Address  Department of Panchakarma Government Ayurvedic College and Hospital, Kadamkuan, Patna.
Department of Panchakarma Government Ayurvedic College and Hospital, Kadamkuan, Patna 800003,Bihar
Patna
BIHAR
800003
India 
Phone  8002680973  
Fax  -  
Email  drapsinghpatna@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College and Hospital, Patna, Bihar 
 
Primary Sponsor  
Name  Government Ayurvedic College and Hospital Kadamkuan Patna 
Address  Department of Panchakarma Government Ayurvedic College and Hospital, Kadamkuan, Patna 800003,Bihar 
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 
Dr Suman Lata  Government Ayurvedic College and Hospital  Government Ayurvedic College and Hospital, Kadamkuan, Patna- 800003 Bihar
Patna
BIHAR 		 7635044262
-
slatasuman159@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee(IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virechana-karma, विरेचन-कर्म (Procedure Reference: chakradatta samhita amavat chikitsa 25/1-2, Procedure details: Patient will be given nitya virechana for 15 days by Gandharvahastadi kashaya along with anupana of saindhav lavan and gud.)
(1) Medicine Name: Gandharvahastadi Kashaya, Reference: Sahashra Yogam Pratham Prakaran Kashaya yog 105, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient having sign and symptom of amavata as mentioned in madhav nidan.
Both seropositive and seronegative cases of amavata.
Age above 20 years and below 70 years.
Chronicity greater than 3 month and less than 10 year 
 
ExclusionCriteria 
Details  Patients in Gouty arthritis, septic arthritis, osteoarthritis & ankylosis spondylitis.
Patients having severe degree of deformity & complications, as per updravas described in ayurvedic texts like Madhav Nidan.
Pregnancy & lactation.
Patients with Hepatitis B (HBsAg) positive, Hepatitis C positive and HIV Positive Patients with COVID 19 Positive.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The subjective assessment will be done on the basis of improvement in the sign & symptom i.e Sandhi Shoola (joint pain),Sandhi shotha (joint swelling),Sandhi stabdata (joint stifness)of Amavat describe in the ayurvedic classics before, during & at the end of the trail  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in RA factor, C reactive protein, Anti-ccp, Esr ,Serum uric acid  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 2 
Date of First Enrollment (India)   22/05/2024 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [slatasuman159@gmail.com].

  6. For how long will this data be available start date provided 25-03-2025 and end date provided 25-03-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study is randomised open interventional prospective trail to study the clinical effect of virechana karma by gandharvahastadi kashaya in the management of amavata w.s.r to rheumatoid arthritis in a group of 40 patients. this study will be conducted in Government AY. College and hospital,patna,Bihar in the department of panchakarma. After 15 days of interventin to follow up will be done in every 15 days , for total duration of the study i.e of 45 days. 
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