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CTRI Number  CTRI/2020/07/026778 [Registered on: 24/07/2020] Trial Registered Prospectively
Last Modified On: 09/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha
Other (Specify) [VARMA MANIPULATION]  
Study Design  Other 
Public Title of Study   A clinical study on kuthikaal vatha kudineer and Nochi ilai kattu for kuthikaal vatham(Calcaneal spur) 
Scientific Title of Study   An open labelled double arm non randomised phase II clinical trial to compare the efficacy of VARMA MANIPULATION with KUTHIKAAL VATHA KUDINEER (internal)and NOCHI ILAI KATTU(external)in the treatment of KUTHIKAAL VATHAM 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  A SATHIYA 
Designation  PG SCHOLAR 
Affiliation  GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI 
Address  DEPARTMENT OF VARMA MARUTHUVAM OP NO 4 GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
DEPARTMENT OF VARMA MARUTHUVAM OP NO 4 GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India 
Phone  6382719113  
Fax    
Email  dr.sathyaraman15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S SUJATHA 
Designation  LECTURER 
Affiliation  GOVT SIDDHA MEDICAL COLLEGE  
Address  DEPARTMENT OF VARMA MARUTHUVAM OP NO 4 GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
DEPARTMENT OF VARMA MARUTHUVAM OP NO 4 GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India 
Phone  9445816706  
Fax    
Email  sujatharajasekar66@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S SUJATHA 
Designation  LECTURER 
Affiliation  GOVT SIDDHA MEDICAL COLLEGE  
Address  DEPARTMENT OF VARMA MARUTHUVAM OP NO 4 GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
DEPARTMENT OF VARMA MARUTHUVAM OP NO 4 GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India 
Phone  9445816706  
Fax    
Email  sujatharajasekar66@gmail.com  
 
Source of Monetary or Material Support  
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI 
 
Primary Sponsor  
Name  Government siddha medical college and hospital 
Address  DEPARTMENT OF VARMA MARUTHUVAM GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI TAMILNADU 627002 
Type of Sponsor  Government 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 
SATHIYA  GOVT SIDDHA MEDICAL COLLEGE  DEPARTMENT OF VAMA MARUTHUVAM OP NO 4 GOVT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI TIRUNILVELI
Tirunelveli
TAMIL NADU 		 6382719113

dr.sathyaraman15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M216||Other acquired deformities of foot,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Varma manipulation for 48 days intermittently with internal medicine and external medicine  Varma manipulation intermittently for 48 days with kuthikaal vatha kudineer internal dose 90ml bd(before food) duration 12 days and Nochi ilai kattu (external) duration 48 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patient having symptoms of sharp pain like knife in the heel when standing up in the morning ,a dull ache in the heel throughout the rest of the day patient who are willing to give radiological investigation and provide blood for lap invetigation patient willing to sign the informed consent stating that he/she will conscientiously sick to the treatment during 48 days but can option out of the trial of his/her own conscious giscretion 
 
ExclusionCriteria 
Details  fracture of the foot ,pagets disease affecting the calcanium,rupture of Achilles tendon,systemic disorder like TB,DM,HIV,Leukaemia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of change from baseline in Universal Pain Assessment scale at day 48 between GroupI(Varma therapy)and GropII(Medicine and Varma therapy) comparison of efficacy in patient GroupI and GroupII  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)   24/07/2020 
Date of Study Completion (India) 18/03/2021 
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   calcneal spurl -the spike of bone at the anterior edge of the calcanum on the medial aspect is otherwise calcaneal spur.According to siddha text  the sgn and symptoms of kuthikaal vatham is correlated with calcaneal spur. This study is evaluate the efficacy of varma manipulation and cilnical efficacy of kuthikaal vatha kudineerinternal)nohi ilai kattu (external). The manipulation of varma points for treating disease called varma therapy.  
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