| CTRI Number |
CTRI/2025/05/086492 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| 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
|
Integrated Yoga for Psoriasis |
|
Scientific Title of Study
|
Designing, Validation and feasibility of an integrated Yoga Therapy Module for Psoriasis. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jolly Thomas |
| Designation |
MSc Yoga Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Div. of Yoga, CIMR, MAHE, Manipal
Opp to Artificial Limb Centre
Udupi
KARNATAKA
576104
India |
| Phone |
8129424614 |
| Fax |
|
| Email |
jollythomas79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEETINAKUMAR PATIL |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Div. of Yoga, CIMR, MAHE, Manipal
Opp to Artificial Limb Centre
Udupi
KARNATAKA
576104
India |
| Phone |
9886211008 |
| Fax |
|
| Email |
ayushnitin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NEETINAKUMAR PATIL |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Div. of Yoga, CIMR, MAHE, Manipal
Opp to Artificial Limb Centre
KARNATAKA
576104
India |
| Phone |
9886211008 |
| Fax |
|
| Email |
ayushnitin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Madhav Nagar Manipal, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education Manipal |
| Address |
Division of Yoga CIMR, MAHE Manipal, India - 576104 |
| Type of Sponsor |
Other [Deemed to be University] |
|
|
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 |
| DR NEETINAKUMAR PATIL |
Kasturba Hospital |
Room No1, 1st Floor, Dormitory building (Opp. Artificial Limb
Center) Division of Yoga Centre for Integrative Medicine and
Research, Manipal, India [CIMR] Udupi
Udupi
KARNATAKA |
9886211008
ayushnitin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care (conventional Medicine) |
Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) Guidelines for the Management of Psoriasis |
| Intervention |
Standard Care and Integrated Yoga |
- Consists of Asanas, Pranyama and Relaxation techniues for 1 hour per day/ 5 days a week for 30days (Validated Yoga Module for Psoriasis) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Men and women with a clinical diagnosis of psoriasis.
2.Those who are willing to participate in yoga program.
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe other comorbidities.
2. Patients who did recent skin treatments, or other conditions that could interfere with yoga practice.
3. Patients who are practicing Yoga for the last 3 month
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Psoriasis Area and Severity Index (PASI)
Dermatology Life Quality Index (DLQI)
Perceived Stress Scale (PSS)
|
At Baseline - Day 0
Post - Day 30th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability |
Baseline - Day 0
Post - Day 30th |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
20/05/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Psoriasis is a chronic inflammatory skin disease that significantly affects both physical and psychological health. While conventional treatments manage symptoms, they often overlook the psychosocial burden, particularly stress, which can worsen the condition. Yoga, as an integrative therapy, offers potential benefits through postures, breathing, and meditation, promoting stress reduction and improved well-being. However, despite some case reports, a validated yoga module for psoriasis and its clinical feasibility/ pilot remains underexplored and warrants further research. |