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CTRI Number  CTRI/2023/06/053840 [Registered on: 14/06/2023] Trial Registered Prospectively
Last Modified On: 28/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Does exposure of limb to sudden temperature alteration will cause chronic venous disease? 
Scientific Title of Study   Exploring the association between sudden limb exposure to temperature alteration following an exertion with varicose vein & chronic venous disease - A case control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma, Cheruthuruthy 
Address  Dept of Ayurveda, Room no.621, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur

Thrissur
KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma, Cheruthuruthy 
Address  Dept. of Ayurveda, Room No. 621, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
Thrissur
KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pratap Shankar K M 
Designation  Research Officer (Ay.) 
Affiliation  National Ayurveda Research Institute for Panchakarma 
Address  Dept. of Ayurveda, Room No. 621, National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
Thrissur
KERALA
679531
India 
Phone  9744824014  
Fax    
Email  kmpvarma@gmail.com  
 
Source of Monetary or Material Support  
National Ayurveda Research Institute for Panchakarma 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  AYUSH Bhawan, Janakpuri, New Delhi 
Type of Sponsor  Research institution 
 
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 
Pratap Shankar K M  National Ayurveda Research Institute for Panchakarma  National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur
Thrissur
KERALA 
9744824014

kmpvarma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I838||Varicose veins of lower extremities with other complications. Ayurveda Condition: SIRAJAGRANTHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Inclusion Criteria for Case:
1. Patients over 18 years with diagnosed chronic venous disease for a duration of less than or equal to 5 years.
2. Patient who are able to recollect and tell the details of exposure and other questions asked by the investigators.
Inclusion Criteria for Control:
1. Patients or healthy volunteers (attenders) satisfying all eligibility criteria defined for cases without chronic venous disease.
2. Patients with different musculoskeletal or neurological diseases diagnosed in a time period less than or equal to 5 years.
 
 
ExclusionCriteria 
Details  Patients with arterial disease, pregnant women, lactating mothers, terminally ill patients, patients with memory impairment and those unwilling to participate were excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association between sudden limb exposure to temperature alteration following an exertion with varicose vein
and chronic venous disease. 
Base line 
 
Secondary Outcome  
Outcome  TimePoints 
association of various characteristics & risk factors with varicose vein and chronic venous disease.  base line 
 
Target Sample Size   Total Sample Size="394"
Sample Size from India="394" 
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)   21/06/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The pathological stages of Chronic venous disease have been evaluated with a range of pathological conditions in Ayurveda such as Siragranthi (venous abnormalities), Raktavarita vāta (disorders of vāta occluded by rakta~ blood), Apana Vaigunya (vitiated apānavāyu), Arsha (hemorrhoids), Vata Rakta (rheumatism due to rakta), Kushtha (integumentary disease), and Dushta Vrana (putrified wound) depending upon the presentations of the patient.

Siragranthi mentioned in ayurvedic texts ideally explains the various venous abnormalities and specifically varicose veins. There are various risk factors hypothesised for the development of varicose veins such as obesity, prolonged standing & sitting, constipation and pregnancy1. But no theory has been proposed as the causative factor for its structural modification of veins and its complications. Astanga Hrdaya has specifically mentioned that a person after any type of exertion like walking or exercise when suddenly washes or dips his legs in water will affect the sira which further undergoes structural changes and results in siragranthi (cyst like venous abnormalities  ~ varicose veins)2. It can be understood that when the veins are dilated during exertion will get contracted by sudden exposure of cold water. Continuous practice of this will lead to loss of elasticity of venous walls which results in venous wall collapse. This cause can be extrapolated to current scenario as a sudden limb exposure to temperature alteration following an exertion. This case control study is aimed to study this association with the development of varicose vein and subsequently chronic venous disease.

 
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