| CTRI Number |
CTRI/2024/10/074653 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Yoga in Atopic Dermatitis |
|
Scientific Title of Study
|
Effectiveness of add-on Yoga therapy compared to standard care on Severity of disease and Quality of Life in individuals with Atopic Dermatitis at tertiary care hospital in Rishikesh, Uttarakhand: A Pilot 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 Vartika Saxena |
| Designation |
Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of Community & Family Medicine, Veerbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
vartika.cfm@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vartika Saxena |
| Designation |
Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
HOD, Department of Community & Family Medicine, AIIMS, Veerbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000294 |
| Fax |
|
| Email |
vartika.cfm@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vartika Saxena |
| Designation |
Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
HOD, Department of Community & Family Medicine, AIIMS, Veerbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000294 |
| Fax |
|
| Email |
vartika.cfm@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| CCRYN, Institutional Area, D block, Janakpuri, New Delhi- 110058 |
|
|
Primary Sponsor
|
| Name |
CCRYN |
| Address |
Institutional Area, D Block, Janakpuri, New Delhi- 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Vartika Saxena |
AIIMS, Rishikesh |
Department of Dermatology & Collaborative Centre of Mind Body Interventions through Yoga
Dehradun
UTTARANCHAL |
8475000294
vartika.cfm@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard care |
Standard care includes liberal emollients, topical steroids, anti-histamines. |
| Intervention |
Yoga therapy & Standard care |
1. Laghu Sankha Prakshalana (LSP)
2. Cyclic meditation
with Standard care which includes liberal emollients, topical steroids, anti-histamines.
Schedule:
1. LSP - once a week for 4 weeks
2. Cyclic meditation - 6 days a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly Diagnosed cases of Atopic dermatitis
Age: ≥18-60 years
Residence: Uttarakhand
Individuals who are willing to provide informed consent.
Individuals with access to smartphones with internet connection. |
|
| ExclusionCriteria |
| Details |
Individuals with other skin conditions that could confound the assessment of eczema, such as psoriasis or infections
Individuals with co-morbidities e.g. diabetes, autoimmune diseases, cardiovascular disorders, joint disorders, deformities, hypertension, hernia, peptic ulcers, coronary artery disease, chronic renal failure, Anal fissures
Pregnant women
Females during menstruation as it is contraindicated during yoga intervention.
Weak and debilitated patients
Individuals with significant cognitive impairments that may hinder their ability to follow instructions during yoga sessions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EASI scores |
Day 0, Day 30/Termination of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
DLQI scores
|
Day 0, Day 30/Termination of trial |
Serum cytokines - CCL17/TARC, IL31
|
Day 0, Day 30/ Termination of trial |
| Serum IgE |
Day 0, day 30/Termination of trial |
| C-reactive protein |
Day 0, Day 30/Termination of trial |
| Neutrophil Lymphocyte ratio |
Day 0, Day 30/Termination of trial |
| Blood eosinophils |
Day 0, Day 30/Termination of trial |
| NFĸB |
Day 0, Day 30/Termination of trial |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/10/2024 |
| 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="2"
Months="0"
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
|
N/A |