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CTRI Number  CTRI/2024/07/070705 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain management of varicose vein by cold leg pack 
Scientific Title of Study   To Evaluate the Effect of Cold Leg Pack on Pain Management in Adults among Varicose Vein Patients - A Randomized Controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J Busrath Sabeena 
Designation  PG Scholar 
Affiliation  International Institute of yoga and Naturopathy Medical Sciences 
Address  184/4, International Institute of yoga and Naturopathy Medical Sciences, Faculty block (Ground floor), Department of Naturopathy, Kamarajar nagar, Ammanambakkam , Chengalpattu - 603001

Kancheepuram
TAMIL NADU
603001
India 
Phone  6382355733  
Fax    
Email  busrasabi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Pandiaraja 
Designation  Assistant Medical Officer / Grade II lecturer 
Affiliation  International Institute of yoga and Naturopathy Medical Sciences 
Address  184/4, International Institute of yoga and Naturopathy Medical Sciences, Faculty block (Ground floor), Department of Naturopathy, Kamarajar nagar, Ammanambakkam , Chengalpattu - 603001

Kancheepuram
TAMIL NADU
603001
India 
Phone  9952448729  
Fax    
Email  drpandiarajamuthupandimd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Pandiaraja 
Designation  Assistant Medical Officer / Grade II lecturer 
Affiliation  International Institute of yoga and Naturopathy Medical Sciences 
Address  184/4, International Institute of yoga and Naturopathy Medical Sciences, Faculty block (Ground floor), Department of Naturopathy, Kamarajar nagar, Ammanambakkam , Chengalpattu - 603001


TAMIL NADU
603001
India 
Phone  9952448729  
Fax    
Email  drpandiarajamuthupandimd@gmail.com  
 
Source of Monetary or Material Support  
184/4, International Institute of yoga and Naturopathy Medical Sciences, Faculty block (Ground floor), Department of Naturopathy, Kamarajar nagar, Ammanambakkam , Chengalpattu - 603001 
 
Primary Sponsor  
Name  Dr J Busrath Sabeena 
Address  184/4, International Institute of yoga and Naturopathy Medical Sciences, Faculty block (Ground floor), Department of Naturopathy, Kamarajar nagar, Ammanambakkam , Chengalpattu - 603001 
Type of Sponsor  Other [Self] 
 
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 J Busrath Sabeena  International Institute of yoga and Naturopathy Medical Sciences  184/4, International Institute of yoga and Naturopathy Medical Sciences, Faculty block (Ground floor), Department of Naturopathy, Kamarajar nagar, Ammanambakkam , Chengalpattu - 603001
Kancheepuram
TAMIL NADU 		 6382355733

busrasabi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
International Institute of yoga and Naturopathy Medical Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I831||Varicose veins of lower extremities with inflammation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cold Leg Pack  Patients will undergo Yoga and Naturopathic Treatments along with Cold Leg pack for 20 minutes a day for 4 days in a week for 5 weeks. 
Comparator Agent  Yoga and Naturopathic interventions  Patient will undergo Yoga and Naturopathic Treatments other than Cold Leg Pack 4 days in a week for 5 weeks 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients positive for manual perforator incompetence test with dilated veins larger than four millimeter under one to fourth stage and willing to give consent are included 
 
ExclusionCriteria 
Details  Patients with Sciatica, Leg Fracture , varicose vein of severe stages, Superficial and deep vein thrombosis, deep Valvular incompetence are excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Analog Scale  Baseline and 5th week 
 
Secondary Outcome  
Outcome  TimePoints 
Venous Clinical Severity Score and Manual perforator Incompetence Test  Baseline and 5th week 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) 31/07/2025 
Date of First Enrollment (Global)  01/08/2024 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  ONLINE

  6. For how long will this data be available start date provided 17-07-2024 and end date provided 16-07-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Varicose veins is that in which lower leg subcutaneous veins that have become convoluted, enlarged, and strained. Western and developed nations have a higher prevalence of this illness. Blood reflux in the lower leg veins is caused by inadequate valves. Varicose veins are currently reported to impact 2%–73% of the world’s population. One of the important hydrotherapy treatment for varicose vein is the cold leg pack. It is a simple, affordable, and effective way to treat and manage a variety of chronic conditions. the application of cold water to the afflicted region improve circulation and reduce swelling and inflammation. A randomized controlled trial design will be adopted for this study. All the eligible subjects  of sample size 80 will be divided into two groups, study group and control group by simple randomization. The study group will have  Yoga and naturopathic treatments along with cold leg pack for 20 minutes a day for 4 days in a week for 5 weeks and control group with Yoga and Naturopathy treatments other than cold leg pack intervention for a period of 4 days in a week for 5 weeks. Assessments will be done before the intervention after the intervention on day one and 5 weeks respectively. As a primary outcome the Visual Analog Scale will be assessed on the baseline and at the end of 5th week. The pain VAS is a unidimensional way to evaluate how much pain a patient is experiencing. It may also be used to compare how much pain individuals with comparable diseases are experiencing. As a secondary outcome the Venous Clinical Severity Score and Manual Perforator  Incompetence test  will be assessed  on baseline and at end of 5th week. Venous clinical severity score (VCSS) calculator is used to track changes in the severity of venous illness. Aching, heaviness, and varicose veins that are larger than 4 millimeters are the items graded in the VCSS. Perform the Manual compression test by having the patient stand and placing the right hand over the distal lower part of the suspected vein and left hand over the proximal vein. Hands will be about 15-20 cm apart, compress the proximal portion of the vein, feels a pulse in distal hand, test is positive. 
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