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CTRI Number  CTRI/2020/07/026639 [Registered on: 17/07/2020] Trial Registered Prospectively
Last Modified On: 07/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha
Other (Specify) [EXTERNAL PATTRU THERAPY]  
Study Design  Other 
Public Title of Study   A clinical study on Azhal keel vayu with Punnai vithai pattru (External therapy) and Ammaiyaar Koonthal Chooranam (Internal Medicine) 
Scientific Title of Study   An open labelled double arm non randomized phase II clinical trial, to evaluate the therapeutic efficacy of punnai vithai pattru (External therapy) Ammaiyaar Koonthal Chooranam (Internal medicine) in the management of Azhal keel vayu (Osteoarthritis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  G Sagaya Shemina Joice 
Designation  PG Scholar 
Affiliation  Govt Siddha Medical College and Hospital 
Address  OP no 4 Department of Pura Maruthuvam Government Siddha Medical College and Hospital Palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone  8760264504  
Fax    
Email  gssjoice@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Ahamed Mohideen 
Designation  Associate Professor 
Affiliation  Government Siddha Medical College and Hospital 
Address  Department of Pura Maruthuvam Government Siddha Medical College and Hospital Palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone  9442542282  
Fax    
Email  dr.ahmed63@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Ahamed Mohideen 
Designation  Associate Professor 
Affiliation  Government Siddha Medical College and Hospital 
Address  Department of Pura Maruthuvam Government Siddha Medical College and Hospital Palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone  9442542282  
Fax    
Email  dr.ahmed63@gmail.com  
 
Source of Monetary or Material Support  
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  Government siddha medical college and hospital 
Address  Government Siddha Medical College and Hospital Palayamkottai Tirunelveli 627002 
Type of Sponsor  Other [Govt Siddha Medical college 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 
G SAGAYA SHEMINA JOICE  Government Siddha Medical College and Hospital  OP no 4 Department of Pura Maruthuvam Government Siddha Medical College and Hospital Palayamkottai Tirunelveli 627002
Tirunelveli
TAMIL NADU 		 8760264504

gssjoice@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Govt Siddha Medical College Palayamkottai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  PATTRU EXTERNAL THERAPY  PATTRU EXTERNAL THERAPY FOR 48 DAYS 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients having symptoms of pain in single or both knee joints, swelling, tenderness, stiffness, crepitation and restricted movements
Patients who are willing to give blood samples for laboratory investigation
Patients who are willing to take x ray before and after treatment
Willing for admission in IPD for 48 days or wiling to attend OPD regularly
Patients who are willing to participate in this study with knowledge of potential risks and who are willing to sign the informed consent 
 
ExclusionCriteria 
Details  Cardiac disease
Rheumatoid and other types of arthritis
Pregnant women and lactating mothers
Trauma, fracture and ligament injury
Patients with any other serious illness
Benign and malignant neoplasm
Immuno compromised patients
Dermatological issues 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of changes from baseline in universal pain assessment scale score at day 48 between Group I (Pattru External therapy) and Group II (Medicine and Pattru external therapy)
Comparison of efficacy in patient Group I and Group II 		 48 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of quality of life by universal pain score scale
Assessment of safety parameters 		 48 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   23/07/2020 
Date of Study Completion (India) 01/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Osteo arthritis is a form of arthritis that features the breakdown and eventual loss of the cartilage of one or more joints. Eventually, cartilage begins to degenerate by flaking or forming tiny crevases. Osteoarthritis usually affects the weight bearing joint(i.e.knee joint, hip joint).The most common symptoms of Osteo arthritis in pain in the joint after repetitive use along with loss of range of motion and function.
 A pattru (Poultice) is a form of herbal paste is obtained from plant extracts or grinding raw drugs with or without processing them. Normallt the medicine to be applied is made into a thick paste and applied over the affected region.
 
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