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CTRI Number  CTRI/2024/05/068191 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 25/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   suttigai for kuthikaal vaatham 
Scientific Title of Study   An Open Single Arm Clinical Trial to determine the therapeutic effectiveness of uloga suttigai (Metal Cauterization) in the management of kuthikaal vaatham (Achilles Tendon Bursitis) 
Trial Acronym  kkv 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MLavanya 
Designation  PG scholar 
Affiliation  National institute of siddha 
Address  Department of Pura maruthuvam National Institute Of Siddha Ayotidoss padithar hospital Tambaram sanatorium

Kancheepuram
TAMIL NADU
600047
India 
Phone  9384544961  
Fax    
Email  lavanyamanu98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrDPeriyasami 
Designation  Associate Professor 
Affiliation  National institute of siddha 
Address  Department of Pura maruthuvam National Institute Of Siddha Ayotidoss padithar hospital Tambaram sanatorium

Kancheepuram
TAMIL NADU
600047
India 
Phone  7358481734  
Fax    
Email  sami2011nis@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrDPeriyasami 
Designation  Associate Professor 
Affiliation  National institute of siddha 
Address  Department of Pura maruthuvam National Institute Of Siddha Ayotidoss padithar hospital Tambaram sanatorium

Kancheepuram
TAMIL NADU
600047
India 
Phone  7358481734  
Fax    
Email  sami2011nis@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha and Ayothidoss Pandithar Hospital Tambaram sanatorium kachipuram 600047 Tamilnadu India  
 
Primary Sponsor  
Name  M Lavanya 
Address  Room no 14 Puramaruthuvam OPD National Institute of Siddha Tambaram Sanatorium Kanchipuram 600047 Tamilnadu India 
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 
DrM lavanya  Ayotidoss pandithar hospital  Room no 14 Department of pura maruthuvam National institute of siddha Tambaram sanatorium
Kancheepuram
TAMIL NADU 		 9384544961

lavanyamanu98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M715||Other bursitis, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Suttigai therapy  7 days once suttigai therapy will be done maximum 5 sittings will be needed  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with the signs and symptoms of
Pain
Swelling
Soft inflamed nodule
Patients who are willing to give routine blood investigations
Patients who are willing to participate in the study by signing the consent by fulfilling the conditions of proforma. 
 
ExclusionCriteria 
Details  K/C/O Uncontrolled diabetes and hypertension
K/C/O Rheumatoid arthritis
Fracture of ankle joint
K/C/O Septic arthritis
Completely ruptured tendon and ligaments of ankle joints
K/C/O gouty arthritis
K/C/O Psoriatic arthritis
K/C/O Keloid
Patients who are not willing to undergo suttigai therapy
Patients who are not willing to give blood samples for routine investigations
Pregnant & lactating women and psychiatric patients 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the improvement in the clinical symptoms like pain, swelling, tenderness, soft inflamed nodule, difficulty in walking using Subjective parameter (VAS Scale), Objective parameter (Swelling, Tenderness) and foot -ankle disability scale  48 days 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   10/06/2024 
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="1"
Months="6"
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 - NO
Brief Summary   This study is conducted To assess the improvement in the clinical symptoms like pain, swelling, tenderness, soft inflamed nodule, difficulty in walking using Subjective parameter (VAS Scale), Objective parameter (Swelling, Tenderness) and foot -ankle disability scale
Study design: An open single arm clinical trial
Patients reporting with symptoms will be subjected to screening test and documented. The patients who were enrolled will be informed about the procedure. All the enrolled patients were given researchers phone number for easily contact the researcher for clearing their doubts and any complaints arises during the trial. Complete clinical history, complaints and duration, examination findings and laboratory investigations—will be recorded in the prescribed proforma. The patient will be followed up for the treatment duration.
 
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