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CTRI Number  CTRI/2016/11/007510 [Registered on: 29/11/2016] Trial Registered Prospectively
Last Modified On: 22/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Ayurvedic management of amavata (Rheumatoid arthritis) 
Scientific Title of Study   A clinical study of vardhamana pippali kalpa in the management of amavata vis-a-vis rheumatoid arthritis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha T Parmar 
Designation  PG scholar 
Affiliation  J S Ayurveda college and P D patel ayurveda hospital Nadiad 
Address  J S Ayurveda college college road Nadiad
J S Ayurveda college college road nadiad 387001
Kheda
GUJARAT
387001
India 
Phone  9714754287  
Fax    
Email  dr.manishaparmar41@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manishkumar V Patel 
Designation  BAMS,MD (Ayu) 
Affiliation  J S Ayurveda college and P D patel ayurveda hospital Nadiad 
Address  J S Ayurveda mahavidhyalaya campus college road Nadiad
J S Ayurveda mahavidhyalaya campus college road Nadiad
Kheda
GUJARAT
387001
India 
Phone  9979589865  
Fax    
Email  manishayu97@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Manisha T Parmar 
Designation  PG scholar 
Affiliation  J S Ayurveda college and P D patel ayurveda hospital Nadiad 
Address  J S Ayurveda college college road Nadiad
J S Ayurveda college college road Nadiad
Kheda
GUJARAT
387001
India 
Phone  9714754287  
Fax    
Email  dr.manishaparmar41@gmail.com  
 
Source of Monetary or Material Support  
J S Ayurveda college and P D Patel Ayurvedic hospital 
 
Primary Sponsor  
Name  J S ayurveda college 
Address  J S Ayurveda college college road Nadiad 
Type of Sponsor  Private medical college 
 
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 
Manisha T Parmar  P D Patel Ayurveda Hospital   kaychikitsha department room no 204
Kheda
GUJARAT 		 9714754287

dr.manishaparmar41@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
J S ayurveda hospital and P D patel ayurveda hospital Nadiad Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  amavata (rheumatoid arthritis),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayurvedic classical herbal formulation  Pippali churna in vardhmana krama,i.e. starting the dose from 1 gm on the first day, twice a day with hot water will given. It will be increased by 1 gm daily up to a maximum dose of 5 gm twice a day. The maximum dose, i.e.5 gm will be given for 5 days and then it will be tapered by 1 gm daily to a dose of 1 gm twice a day.  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Presence of sandhiÅ›ula (pain in joints), sandhijādyatā (stiffness in joints), sandhisotha (swelling in joints), restriction of movement.
2.Presence of any six out of the following ten classification criteria and European league against rheumatism (EULAR).
 
 
ExclusionCriteria 
Details  1.Patients who have developed complications of rheumatoid arthritis e.g. Severe deformity of jointsones, pleura-pericardial disease, or else.
2.Association of a joint disease of other origin.
3.Patients having HbA1c above 7.5 of diabetes mellitus.
4.Patients on prolonged medication with immunosuppressive e.g. corticosteroids any other drugs within last 6 months that may have an influence on the outcome of the study.
5.Pregnant/lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
effect of the vardhamana pippali kalpa in the patients of amavata  Grade score of signs and symptoms 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  Not Applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/01/2017 
Date of Study Completion (India) 16/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable this thesis work will yet to be submit 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Clinical evaluation of the effectiveness of vardhaman pippali kalpa in the management of amavata is the main object of the study. Patients will be selected from the P D Patel ayurveda hospital, Nadiad, after the confirmation of the diagnosis of amavata with the help of classical signs and symptoms. they will be treated with Powder of pippali (Piper longum Linn.) in vardhmana krama,i.e. starting the dose from 1 gm on the first day, twice a day with hot water will given. It will be increased by 1 gm daily up to a maximum dose of 5 gm twice a day. The maximum dose, i.e.5 gm will be given for 5 days and then it will be tapered by 1 gm daily to a dose of 1 gm twice a day. Patients will be kept on mudgayuá¹£a. Total duration of the treatment will be of 13 days. Assessment will be done with the help of changes in gradation of the signs and symptoms of amavata, ESR, DAS-28 scale, disability  index (the indian health assessment questionnaire). Result will be analysed with student t test.  
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