| CTRI Number |
CTRI/2023/05/052928 [Registered on: 19/05/2023] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Yoga Therapy in the management of Varicose Veins |
|
Scientific Title of Study
|
Impact of Yoga Therapy on D-Dimer Test Among Middle Aged Men Diagnosed with Varicose Veins |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K BADRI |
| Designation |
SCHOLAR |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai-600078
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai-600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9444625259 |
| Fax |
|
| Email |
gccbadri12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subbulakshmi V |
| Designation |
Associate Professor |
| Affiliation |
Meenakshi Academy of Higher Education and Research (Deemed to be University) |
| Address |
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai-600078
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai-600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9176794264 |
| Fax |
|
| Email |
vslakshmi321@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
K BADRI |
| Designation |
SCHOLAR |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai-600078
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai-600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9444625259 |
| Fax |
|
| Email |
gccbadri12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Academy of Higher Education and Research, (Deemed to be University), West. K.K Nagar, Chennai |
|
|
Primary Sponsor
|
| Name |
K. BADRI |
| Address |
NO 17 BHARATHI NAGAR 1ST STREET VILLIVAKKAM CHENNAI 600049 |
| Type of Sponsor |
Other [Scholar] |
|
|
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 |
| K Badri |
Meenakshi Academy of Higher Education and Research |
Department: Faculty of Yoga Science and Therapy
Division: 3rd floor
Room No: 303
No. 12, Vembuliamman Koil Street, West K K Nagar, Chennai-600078
Chennai
TAMIL NADU |
9444625259
gccbadri12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I839||Asymptomatic varicose veins of lower extremities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Yoga Therapy |
Asana, pranayama, meditation, mudras, chanting would be used and modified according to the needs.
Frequency : 3 times a Week
Total Duration : 3 Months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Those diagnosed with varicose veins based on CEAP classification, symptoms C2.
2. Assessed suitable for practicing yoga therapy based on physical exam.
3. No history of practicing yoga or other exercises. |
|
| ExclusionCriteria |
| Details |
1. Blood clotting disorders.
2. Patients on prolonged anti-coagulant drugs.
3. Active clinical surgery or other major clinically Significant disorder/ disease.
4. Presence of any tumor.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
What: D-Dimer Test
When: Pre Test and Post Test |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. 6 Minutes Walk Test
2. Heart Rate
3. Ankle Brakeal Index
4. Job Satisfaction Questionnaire |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/06/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study would
be conducted for the partial fulfilment of the Ph.D study at Meenakshi Academy of Higher Education
and Research (Deemed to be University), Chennai.
Prolonged standing
at work has been an important risk factor for varicose veins. Varicose veins
(VV) are abnormally swollen, tortuous, and prominent veins caused by
insufficient venous valves leading to venous congestion and elevated venous
pressure. (Busbaih Z et. al., 2022)
Impact
of yoga therapy on D-Dimer test among middle aged men diagnosed with varicose veins
is a randomized, parallel group, active controlled trial. Anyone of the following
randomization method will be used coin toss/lottery/toss of dice or shuffling
cards. According to the National Clinical Guideline Centre and CEAP (Clinical,
Etiological, Anatomical and Pathophysiological) Classification of lower limb
varicose veins (2004): skin with varicose vein visible (C2) will be selected
for the study. The subjects will be middle aged men. The total number of sample
size is determined to be 60 statistically.
Based on the information obtained, subjects will be divided into two
groups: yoga therapy group (30) and control group (30). The duration of the
study is planned to be three months. The
primary outcome variable of the study is D-Dimer Test. The secondary outcome variables are 6 Minutes’
Walk test, Heart Rate, Ankle Brikeal Index, Job Satisfaction Questionnaire. Pre-test
and Post-test will be conducted for all the selected samples on all the outcome
measures. Subjects will receive yoga therapy training for 3 months. In the
Control Group, they will engage in active rest.
Paired t test would be used to find out the effectiveness of the study. |