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CTRI Number  CTRI/2018/08/015558 [Registered on: 31/08/2018] Trial Registered Prospectively
Last Modified On: 22/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFECT OF YOGA THERAPY IN SKIN DISORDER(PSORIASIS) 
Scientific Title of Study   EFFECT OF YOGA THERAPY IN MODIFYING STRESS IN PATIENTS WITH PSORIASIS: A RANDOMIZED CONTROL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dayanidy G 
Designation  Lecturer 
Affiliation  Sri Balaji Vidyapeeth 
Address  CYTER of Sri Balaji Vidyapeeth MGMCRI Campus Pillayarkuppam, Pondicherry-607403

Pondicherry
PONDICHERRY
607403
India 
Phone  9789210593  
Fax    
Email  dayanidy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ananda Balayogi Bhavanani 
Designation  Director 
Affiliation  Sri Balaji Vidyapeeth 
Address  CYTER of Sri Balaji Vidyapeeth MGMCRI Campus Pillayarkuppam, Pondicherry-607403

Pondicherry
PONDICHERRY
607403
India 
Phone  9842311433  
Fax    
Email  yoga@mgmcri.ac.in  
 
Details of Contact Person
Public Query  
Name  Ananda Balayogi Bhavanani 
Designation  Director 
Affiliation  Sri Balaji Vidyapeeth 
Address  CYTER of Sri Balaji Vidyapeeth MGMCRI Campus Pillayarkuppam, Pondicherry-607403

Pondicherry
PONDICHERRY
607403
India 
Phone  9842311433  
Fax    
Email  yoga@mgmcri.ac.in  
 
Source of Monetary or Material Support  
CYTER of Sri Balaji Vidyapeeth, SBV Campus, Pillaiyurkuppam, Pondicherry- 607403 
 
Primary Sponsor  
Name  Sri Balaji Vidyapeeth 
Address  MGMCRI campus, Pillaiyurkuppam, Pondicherry- 607403. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dayanidy G  CYTER of Sri Balaji Vidyapeeth  1st Floor, I Block,MGMCRI Pillayarkuppam, Pondicherry-607403
Pondicherry
PONDICHERRY 		 9789210593

yoga@mgmcri.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Patients with psoriasis on medical management, (1) ICD-10 Condition: L400||Psoriasis vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Yoga Therapy  Validated Yoga Therapy protocol will be given to subjects in the experimental group. (Total duration: 50 min) Participants will be motivated to practice at home and maintain a diary that will be used to evaluate compliance and for correlation analysis if possible at the end of the study. Post-test analyses of all parameters will be done again at end of 3-month study period to assess effects of yoga therapy.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with Chronic psoriasis (Illness for more than 3 months) on medical management.
Able to perform the techniques in the protocol.
Willing to participate in yoga therapy
 
 
ExclusionCriteria 
Details  Patients having salivary gland tumour.
Patients having hormone replacement therapies, contraceptives, oral and injectable steroid.
Medical condition affecting Hypothalamic–Pituitary–Adrenal (HPA) Axis(Cushing’s& Addison’s syndrome)
Already participating in yoga on regular basis
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a. To evaluate the effect of adjuvant yoga therapy and compare with standard medical management alone on
i. Anthropometric parameters (weight and Body Mass Index).
ii. Physiological parameters (blood pressure and heart rate).
iii. Psychological parameters (PSS, DQOL).
iv. Biochemical parameter (Salivary cortisol).
b. To evaluate clinical changes of adjuvant yoga therapy through Psoriasis Area and Severity Index (PASI) scale and compare with standard medical management alone. 		 Evaluation will be done before and after 3 months for each patient. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  NA 
 
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)   27/09/2018 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Introduction:

Psoriasis is an immune-mediated disease that causes raised, red, scaly patches to appear on the skin. Stress appears to be an important precipitating factor in the development and exacerbation of psoriasis. The proportion of psoriasis patients who believe stress affects their skin condition (i.e., "stress responders") is considerably high, ranging from 37% to 78%. Stress, weaken the immune system and increase vulnerability to infection and other health-related problems. Stress may worsen psoriasis severity and may even lengthen the time to disease clearance. Yoga is a mind-body practice that combines physical poses, controlled breathing, and meditation or relaxation. Several studies shows that yoga helps reduce stress, lower blood pressure, normalize your heart rate and improve quality of life. However, the effect of yoga therapy in modifying stress in patients with psoriasis has not been reported so far. To the best of our knowledge, the present study may be the first of its kind to be reported in the literature.

 

Aims and Objectives:

Aim: To study the effect of yoga as adjuvant therapy and compare with standard medical management alone in modifying stress in patients with psoriasis.

Objectives:

1.      To evaluate the effect of adjuvant yoga therapy and compare with standard medical management alone on

a.       Anthropometric parameters (weight and Body Mass Index).

b.      Physiological parameters (blood pressure and heart rate).

c.       Psychological parameters (PSS, DQOL).

d.      Biochemical parameter (Salivary cortisol).

2.      To evaluate clinical changes of adjuvant yoga therapy through Psoriasis Area and Severity Index (PASI) scale and compare with standard medical management alone.

 

Subjects and Methods:

The present study will be conducted among patients admitted in the dermatology ward of the Mahatma Gandhi Medical College and Research Institute who have been clinically diagnosed with psoriasis. The patients will be prospectively interviewed and enrolled for the study after fulfilling the inclusion and exclusion criteria. Subjects will be informed about the study and their consent will be taken.

Using Sample Size Calculator Application, Sample size was calculated with confidence level of 95%, power 80%, effect size is 0.6, and ratio is 1, altogether minimum total sample size needed is 90. Adding 10% dropout, we get sample size of 100 for the present study. 

Using Block randomization subjects (n=100) will be divided into two groups. Group A - Bi weekly yoga therapy for 3 months with standard medical management (n=50). Group B – Controls - standard medical management (n=50) and by using zelen’s design subject group change will be done.

Work Plan:

·         100 patients of chronic psoriasis (Illness for more than 3 months) on standard medical management will be recruited after obtaining informed consent.

·         Randomization of subjects will be done into

o   Group A of 50 subjects (yoga therapy for 3 months with standard medical management) and

o   Group B of 50 subjects (controls receiving only standard medical management).

·         Pre study evaluation of

o   Anthropometry: height, weight, BMI.

o   Physiological parameter: BP, HR

o   Psychological parameter: (PSS), (DQoL)

o   Biochemical parameters: Salivary Cortisol

o   Clinical Parameter: Psoriasis Area and Severity Index (PASI) scale.

·         Yoga Therapy as per the CYTER protocol will be given to subjects in the experimental group. (Total duration: 50 min)

·         Participants will be motivated to practice at home and maintain a diary that will be used to evaluate compliance and for correlation analysis if possible at the end of the study.

·         Post-test analyses of all parameters will be done again at end of 3-month study period to assess effects of yoga therapy.

·         Data analyses will be done.

·         Changes in all parameters will be correlated with compliance to Yoga Therapy will be assessed.

·         Preparation of final report for publication.

·         After the study period, Yoga therapy will be offered to control subjects who are interested.

 

Statistical Methods:

·         Student’s paired t test will be used for intra group comparisons for data passing normality testing and Wilcoxon matched-pairs signed-ranks test for others.

·         Students unpaired t test will be used for inter group comparison for data passing normality testing and ManWhitney U test otherwise.

·         P value <0.05 will be considered as significant.

 
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