| CTRI Number |
CTRI/2025/04/084198 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of different type of exercises on pain in females with varicose veins. |
|
Scientific Title of Study
|
To evaluate the effects of Onshore exercises vs Buergers exercises in varicose veins among women: An experimental study |
| 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 Nency Pandya |
| Designation |
Assistant professor |
| Affiliation |
K.M.Patel Institute of Physiotherapy |
| Address |
K.M.Patel Institute of Physiotherapy, Shree Krishna hospital, Gokalnagar, Karamsad, Anand
Anand
GUJARAT
388325
India |
| Phone |
9723501302 |
| Fax |
|
| Email |
ncypandya_11@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Unnati Mehta |
| Designation |
First Year PG student |
| Affiliation |
K.M.Patel Institute of Physiotherapy |
| Address |
K.M.Patel Institute of Physiotherapy, Shree Krishna hospital, Gokalnagar, Karamsad, Anand, Gujarat
K.M.Patel Institute of Physiotherapy, Shree Krishna hospital, Gokalnagar, Karamsad, Anand, Gujarat
Anand
GUJARAT
388325
India |
| Phone |
7016114296 |
| Fax |
|
| Email |
unnatimehta31036@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nency Pandya |
| Designation |
Assistant professor |
| Affiliation |
K.M.Patel Institute of Physiotherapy |
| Address |
K.M.Patel Institute of Physiotherapy, Shree Krishna hospital, Gokalnagar, Karamsad, Anand
Anand
GUJARAT
388325
India |
| Phone |
9723501302 |
| Fax |
|
| Email |
ncypandya_11@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Electrotherapy OPD, department number - 152, K.M.Patel Institute of Physiotherapy, Shree Krishna hospital, Karamsad, Anand, Gujarat, India, 388325 |
|
|
Primary Sponsor
|
| Name |
Dr Nency Pandya |
| Address |
K.M.Patel Institute of Physiotherapy, Shree Krishna hospital, Gokalnagar, Karamsad, Anand, Gujarat,India 388325 |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Unnati Mehta |
K.M.Patel Institute of Physiotherapy, Shree Krishna hospital, Gokalnagar, Karamsad, Anand, Gujarat 388325 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNency Pandya |
K.M.Patel Institute of Physiotherapy |
Electrotherapy OPD, department no. 152, ground floor, Shree Krishna hospital, Karamsad
Anand
GUJARAT |
9723501302
ncypandya_11@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-2 Bhaikaka University, Karamsad, Anand, Gujarat-388325 [DHR Reg. No. EC/NEW/INST/2021/592][OHRP Reg. No. IRB00014178] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I83||Varicose veins of lower extremities, (2) ICD-10 Condition: I831||Varicose veins of lower extremities with inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buergers exercises |
Buergers exercises will be demonstrated on first day and then online session will be conducted for 4 days a week for 4 weeks. pre and post outcome measures will be taken |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Onshore exercise |
Onshore exercises will be demonstrated on first day and then online session will be conducted for 4 days a week for 4 weeks. pre and post outcome measures will be taken |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Referred and diagnosed cases of varicose veins at C1-C5 stages by a vascular surgeon.
Women at any age with or without surgery for the same. |
|
| ExclusionCriteria |
| Details |
Pregnant females.
Women who have other peripheral arterial or venous disease.
Women who have knee pain and low back pain. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS (Visual Analogue Scale) |
At baseline after enrollment of participants and at the end of intervention after 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 6MWT (6-Minute Walk Test) |
At baseline after enrollment of participants & at the end of intervention after 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/04/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is randomised controlled trial on females with varicose veins diagnosed by vascular surgeon. All the participants will be randomised through computer generated randomisation method. one group will receive buerger’s exercises and other group will receive onshore exercises for 4 weeks comprising 4 sessions per week. Pre and post outcome measures will be VAS and 6-minute walk test. Analysis will be done using appropriate statistical tests between two groups and also in each group before and after the intervention. |