| CTRI Number |
CTRI/2024/06/068374 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the Effects of Twelve Weeks of Yoga Therapy on Cardiovascular Functions in People with Psoriasis |
|
Scientific Title of Study
|
Effects of Twelve Weeks of Adjuvant Yoga Therapy on Cardiovascular Autonomic Functions in People with Psoriasis -A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidyavarrdhini R |
| Designation |
Postgraduate student (First year) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Physiology First floor JIPMER Academic Centre, Jawaharlal Institute of Postgraduate Medical Education and Research,Puducherry-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
6380078571 |
| Fax |
|
| Email |
vidyavarrdhini24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pravati Pal |
| Designation |
Professor (Level 15) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Physiology,
First floor JIPMER Academic Centre , Jawaharlal Institute of Postgraduate Medical Education and Research,Puducherry-65006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9360682406 |
| Fax |
|
| Email |
drpravatipal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidyavarrdhini R |
| Designation |
Postgraduate student (First year) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Physiology First floor JIPMER Academic Centre , Jawaharlal Institute of Postgraduate Medical Education and Research,Puducherry-65006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
6380078571 |
| Fax |
|
| Email |
vidyavarrdhini24@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Intramural Research Funding, Admin block , Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry 605006
India |
|
|
Primary Sponsor
|
| Name |
JIPMER Intramural Research Fund |
| Address |
JIPMER Intramural Research Funding, Admin block,Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006 India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Vidyavarrdhini |
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry |
Dermatology outpatient clinic,Department of Dermatology,Hospital block.
Pondicherry
PONDICHERRY |
6380078571
vidyavarrdhini24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Psoriasis patients receiving their routine Dermatological treatment alone.They will be tested pretest and post test parameters before and after 12 weeks respectively. |
| Intervention |
Yoga Group |
The yoga group individuals are the psoriatic patients who receive yoga therapy for 12 weeks along with their routine Dermatological treatment.
12 weeks of structured yoga therapy is given to them in form of asanas and pranayamas.
The psoriatic subjects in yoga group will be recorded pretest and posttest parameters before and after 12 weeks of yoga therapy. |
| Intervention |
Yoga therapy |
12 weeks of structured yoga therapy is given to the participants in yoga group in the form of asanas, parayamas.
The yoga therapy is given for 45 mins under three supervised sessions in first week and remaining 12 weeks participants are advised to practice in home.Periodic phone calls are made to check whether participants are practicing yoga therapy and the caregiver is motivated to monitor and maintain a compliance diary to make an entry of participants daily practice of yoga. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
People diagnosed with any type of Psoriasis who are stable with routine Dermatological treatment having PASI score less than 10 (mild to moderate severity cases), Duration of treatment more than one year |
|
| ExclusionCriteria |
| Details |
Known case of Diabetes, hypertension, cardiovascular disease, pulmonary,hepatic or renal disease or connective tissue disorders,malignancies, pre-existing endocrine disorders,Pregnant and lactating women,Chronic alcoholics or usage of srugs causing autonomic dysfunction,Individuls ofKnown case of autonomic dysfunction,or psoriatic arthritis or people with severw psoriasis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Heart rate, Blood pressure, Autonomic Function test and Baroreceptor reflex sensitivity parameters |
The parameters are recorded at the baseline and at the end of 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Biochemical markers of stress and inflammation (Cortisol,Interleukin 23, ICAM-1,TNF alpha levels)
Stress score
Sleep score
Quality of life score
Disease severity PASI score |
Improvement in Biochemical markers of stress and inflammation (Cortisol,Interleukin 23, ICAM-1,TNF alpha levels)
Stress score
Sleep score
Quality of life score
Disease severity PASI score after 3 months of yoga therapy |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
Final Enrollment numbers achieved (Total)= "162"
Final Enrollment numbers achieved (India)="162" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
31/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Registered patients from Dermatology OPD JIPMER aged between 18 to 40yrs will be recruited as per inclusion and exclusion criteria.After obtaining written consent they are randomized into yoga group and control group.Pretest parameters are recorded.Yoga group participants will be obtaining yoga therapy in additional to routine Dermatological treatment.Control group will be receiving only their routine Dermatological treatment. After 12 weeks post test parameters are recorded among both groups and compared. |