| CTRI Number |
CTRI/2019/05/019287 [Registered on: 23/05/2019] Trial Registered Prospectively |
| Last Modified On: |
02/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Psych-physiological effects of yoga in lymphodema patients |
|
Scientific Title of Study
|
Effect of yoga on body composition, autonomic function and psychological variables in patients with lymphodema |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shirley Telles |
| Designation |
Director |
| Affiliation |
Patanjali Research Foundation |
| Address |
Department of yoga research, Patanjali Research Foundation, IInd floor,
Patanjali Yogpeeth Phase 1
Haridwar
Department of yoga research, Patanjali Research Foundation, IInd floor,
Patanjali Yogpeeth Phase 1
Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
01334-240008 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shirley Telles |
| Designation |
Director |
| Affiliation |
Patanjali Research Foundation |
| Address |
Department of yoga research, Patanjali Research Foundation, IInd floor,
Patanjali Yogpeeth Phase 1
Haridwar
Department of yoga research, Patanjali Research Foundation, IInd floor,
Patanjali Yogpeeth Phase 1
Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
01334-240008 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shirley Telles |
| Designation |
Director |
| Affiliation |
Patanjali Research Foundation |
| Address |
Department of yoga research, Patanjali Research Foundation, IInd floor,
Patanjali Yogpeeth Phase 1
Haridwar
Department of yoga research, Patanjali Research Foundation, IInd floor,
Patanjali Yogpeeth Phase 1
Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
01334-240008 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation,
Patanjali Yogpeeth Phase 1
Haridwar-249405, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation Trust |
| Address |
Patanjali Yogpeeth, Haridwar-249405 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institute of Applied Dermatology |
Institute of Applied Dermatology
#MP XVI/575(A),
IAD junction, Uliyathadka,
Madhur Road, Kasaragod 671124
Kerala, South India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shirley Telles |
Institute of Applied Dermatology |
MP XVI/575(A), Uliyathadka, IAD junction, Madhur Road, Kerala, Kasargod, Kerala 671124
Kasaragod
KERALA |
01334240008
shirleytelles@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Patanjali Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I890||Lymphedema, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Yoga |
Yoga breathing techniques, Yoga postures and guided relaxation for 45 minutes for 10 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
primary and secondary lymphodema |
|
| ExclusionCriteria |
| Details |
specific swelling of the skin, for example cellulitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Body composition
2. Heart rate variability
3. Limb girth measures
4. Perception of illness
|
Before and after 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. State anxiety
2. Quality of life
|
Before and after 10 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/05/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is planned to see the effect of 10 days of yoga practice on body composition and psychological parameters in patients with lymphodema. This study will help to design a proper yoga module to enhance their quality of life. |