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CTRI Number  CTRI/2018/03/012365 [Registered on: 06/03/2018] Trial Registered Retrospectively
Last Modified On: 19/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   M D Dissertation 
Study Design  Single Arm Study 
Public Title of Study   An open clinical trail on "MERUGULLI THYLAM"(Internal medicine) in the treatment of Mudakkuvatham. 
Scientific Title of Study   An open clinical trail on "MERUGULLI THYLAM"(Internal medicine) in the treatment of "VALI AZHAL KEELVAYU" (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  DR M Suganthi 
Designation  PG scholar 
Affiliation  National Institute of siddha 
Address  Department of Maruthuvam,National Institute of Siddha, Ayodidoss pandithar hospital Tambaram Sanatorium,Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  8056786753  
Fax    
Email  drsuganthi6@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  DR K Manikavasagam 
Designation  Professor 
Affiliation  National Institute of Siddha Tambaram Sanatorium Chennai 47  
Address  Department of Maruthuvam,National Institute of Siddha, Ayodidoss pandithar hospital Tambaram Sanatorium,Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9444249798  
Fax    
Email  dr.kmvm@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR H Vedha merlin kumari 
Designation  Lecturer 
Affiliation  National Institute of siddha 
Address  Department of Maruthuvam,National Institute of Siddha, Ayodidoss pandithar hospital Tambaram Sanatorium,Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Ayodidoss pandithar hospital Tambaram Sanatorium,Chennai  
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium Chennai 47 
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 M Suganthi  Ayothidoss pandithar hospital  Room no 1 Department of Maruthuvam National institute of siddha Tambaram Sanatorium Chennai 47
Kancheepuram
TAMIL NADU 		 8056786753

drsuganthi6@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Arthritis involving three or more joints,Symmetrical joint involvement Morning stiffness swelling of small joints of hand and foot ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Merugulli thylam  kaal balam-9grams(9ml)-3 days morning only (2 days drug holiday) for 45 days  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age:20-60 years
Sex:Both male and female
Symmetrical joint involvement
Arthritis of three or more joints
Rheumatoid factor positive or negative
Morning stiffness
Deformities like Swan neck deformity and Button hole deformity
Swelling especially in the inter-phalangeal joint
Patients willing for admission in IPD or willing to attend OPD
Patient willing to undergo Radiological investigation and for laboratory investigation
Patients willing to sign the informed consent stating that he/she will consciously stick to the treatment during 45 days but can opt out of the trial of his/her own conscious discretion.
 
 
ExclusionCriteria 
Details  Pregnancy and lactation
Tubercular arthritis
Any other serious systemic illness like cancer, cardiac disease
Osteoarthritis
Psoriatic arthritis
Gouty arthritis
Diabetic mellitus
Hypertension
Thyroidism(Hypo/hyper)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of pain is by Universal pain assessment scale.Other clinical signs and symptoms will be assessed by Gradation methods   before and After treatment (45 days) Assessment of pain is by Universal pain assessment scale.Other clinical signs and symptoms will be assessed by Gradation methods  
 
Secondary Outcome  
Outcome  TimePoints 
Laboratory investigations such as RA factor,CRP,ASO titre will also be done at the end of the study  Before and after treatment(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   N/A 
Date of First Enrollment (India)   01/11/2017 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Its is a single non randomized open label trial to determine the efficacy and safety of "MERUGULLI THYLAM"(Herbal formulation) in the patients with VALI AZHAL KEELVAYU(Rheumatoid arthritis) in this trial 40 patients will be recruited and the trial drug will be administered kaal balam-9gram(9 ml)-3 days morning only(2 days drug holiday) for a period of 45 days, During the trail period if any AE/SAF/SUSAR will be noticed and referred to pharmacovigilance department in NIS and further  management will also be given in NIS OPD/IPD. The entire trail will be monitored by the research monitoring committee of NIS. During this trail all the safety efficacy parameters will be recorded in the CRF after completion of the trail all the safety related data will be analysed statistically, the outcome of this trail will be published in Indian Journal of Medical Research. 
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