| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I838||Varicose veins of lower extremities with other complications. Ayurveda Condition: SIRAJAGRANTHIH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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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. |
|
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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 |
|
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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 vÄta (disorders of vÄta occluded
by rakta~ blood),
Apana Vaigunya (vitiated
apÄnavÄyu),
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. |