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CTRI Number  CTRI/2024/10/075831 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy
Other (Specify) [ Nursing intervention based on structured education and relaxation techniques]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of education program and yoga therapy in quality of life of Psoriasis Patients with Ayurvedic Treatment 
Scientific Title of Study   A randomised control trial to assess add- on effect of nurse – led intervention programs of structured education and relaxation techniques in QOL of Psoriasis patients managed through Ayurveda at a tertiary level Ayurveda hospital in New Delhi 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sindhu Rajesh 
Designation  Nursing Superintendent  
Affiliation  College of Nursing Amity University 
Address  Nursing department , Room No. 4 , First floor, Hospital block,All India Institute of Ayurveda Gautam Puri Sarita Vihar New Delhi
PhD (Nursing) Scholar Amity University Gurugram Haryana 1224126
South
DELHI
110076
India 
Phone  9560960379  
Fax    
Email  sindhurajesh2012@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof. Dr. Anu Gauba 
Designation  Professor cum Principal  
Affiliation  Amity University 
Address  Room No. 01, A-Block , Third floor , College of Nursing , Amity University , Manesar, Panchgaon

Gurgaon
HARYANA
1224126
India 
Phone  9810245092  
Fax    
Email  agauba@ggn.amity.edu  
 
Details of Contact Person
Public Query
 
Name  Sindhu Rajesh 
Designation  Nursing Superintendent 
Affiliation  All India Institute of Ayurveda  
Address  Department of Nursing Room No. 4 First floor,Hospital Block,All India Institute of Ayurveda Gautam Puri, Sarita Vihar Sarita Vihar New Delhi

South
DELHI
110076
India 
Phone  9560960379  
Fax    
Email  sindhurajesh2012@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Gautam Puri , Sarita Vihar, New Delhi, India . Pin code 110076  
 
Primary Sponsor  
Name  All India Institute of Ayurveda  
Address  Gautam Puri Sarita Vihar New Delhi 
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 
Sindhu Rajesh  All India Institute of Ayurveda  Room No. 4, First floor , Hospital Block,All india institute of ayurveda,sarita vihar
South
DELHI 
9560960379

sindhurajesh2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committtee All India Institute of Ayurveda   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L40||Psoriasis. Ayurveda Condition: KUSHTHAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Ashtangahridayam sutrasthanam Chapter 18, Procedure details: The control group will receive therapy based on the standard treatment, with treatments tailored at each stage as per the physician protocol. The appropriate Shodhana therapy (purification) will be carried out, which may involve either Vamana (therapeutic emesis), Virechana (therapeutic purgation), or both, as determined by the treating physician. )
2Intervention ArmLifestyle--Dinacarya: Yoga relaxation techniques , Ritucarya: NA, Acara Rasayana:NA, Other:Structured education on Hygiene Skin care Prevention of infection Nutrition Diet Pathya Apathya Sleep Rest exercise Sukshma Vyayam Different asana Suryanamaskar Pranayama for 15 20 minutes daily for 15 days A checklist will be maintained on Nurse led interventions which include frequent visit to the patient Minimum 2 times a day & update on treatment process Examine for signs of infection like red swollen skin oozing pus etc Monitor pain two times a day & ensure compliance to d, Pathya/Apathya:yes, Pathya:Old stored rice barley wheat grain Millets Legumes adequate warm water A glass of water or milk infused with two pinch of turmeric More vegetables in the diet, Apathya:Avoid Excessive sweet salty oily spicy & sour food Acidic food stuffs junk sticky packaged preserved food food heated in oven Maida products like bread Consume fermented food items like Dosa or Idli batter on the same day Tea or coffee Soft drinks & alcoholic drinks Curd especially in night excess milk Paneer Jaggery sesame seeds Pappad Black gram
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Male & Female patients with more than two years chronicity and PASI score more than 10 
 
ExclusionCriteria 
Details  Chronicity of less than 2 years
Patients with Severe Systemic disorders
Patients with Psoriatic Arthritis
Patients unfit for relaxation techniques
Patients unwilling to do OM chanting
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)PASI score -Symptomatic Relief in signs and symptoms(itching ,scaling ,discoloration,discharge) of Psoriasis.

2)Improvement in DLQI quality of life
 
Before treatment 0 day,15th,30th and 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Psoriasis Area and Severity Index (PASI) Score.  Before treatment 0 day and after treatment 60th day 
 
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)   01/11/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Psoriasis is a chronic skin condition characterized by thick, raised red patches that are often covered with flaking, silvery scales. Psoriasis  can have substantial physical , psychological and social impact on patient’s life. Psoriasis has been shown to affect health-related Quality of Life to an extent similar to the effects of other chronic diseases such as depression, myocardial infarction, hypertension, cancer etc. The modern treatment options not only provide temporary relief but also have serious side effects. Thus, the chronic and recurring nature of the disease hampers the Quality of Life to a great extent. Information from Quality of Life surveys suggest that 78% of psoriatic indicate the negative impact on their life quality.  

It is necessary to elaborate and implement a program of health education for every patient with psoriasis in order to equip them with the knowledge essential to    enable them to undertake self-care and achieve long-lasting remission of the disease. Health education is an important aspect of psoriatic treatment.

 

Also it has long been acknowledged that the clients affected with psoriasis may benefit greatly from psychotherapeutic interventions. It is possible that stress management through relaxation may result in improvement in these patients. Stress may worsen psoriasis severity and may even lengthen the time to disease clearance.

Significance of this research

Assessing the add- on effect of structured education and relaxation techniques   in QOL of  Psoriasis patients managed through Ayurveda will help to  develop a nursing care protocol based on selected education programs  and relaxation techniques   for management of Psoriasis patients which can be followed , so that their quality of life can be improved . This nursing care protocol can be utilized as a guideline for nursing management of patients with Psoriasis in Ayurveda system.

METHODOLOGY

Research Approach: RCT

Design:     Prospective two arm clinical study (Pretest – Posttest)

Sample size – 50 for each group

INCLUSION CRITERIA

a. Age - 25 -55 yrs

b. PASI > 10

c. Chronicity – 2 Years and more    

EXCLUSION CRITERIA:

a.     Chronicity of less than 2 years

b.     Patients with Severe Systemic disorders

c.     Patients with Psoriatic  Arthritis

d.     Patients unfit for relaxation techniques

e.     Patients unwilling to do OM chanting

Intervention – Structured education program, Nursing intervention  and selected relaxation techniques

  • Randomization will be used for both experimental and control group.
  • Experimental group –After baseline assessment of patient,  structured education, and relaxation techniques will be taught and Nursing intervention based on structured education  will be given.   Nursing intervention checklist, care taker checklist  , material  of structured education  and relaxation techniques will be prepared and validation will  be  done by following standard methods before  starting the data collection.

 

¢  Structured  education  will be given on the first or second day of admission  on the following topics. Repeat session will be taken if necessary or on patient demand  :

ü  Hygiene

ü  Skin care

ü   Prevention of infection

ü  Nutrition & Diet (Pathya & Apathya)

ü  Sleep

ü  Rest & exercise

ü  Productivity of life

ü  Pain management

¢  Nurse -led intervention for Management of Psoriasis

1.     Specific nursing interventions bases on structured education  & maintaining the checklist

2.     Dietary management 

3.     Practice of relaxation techniques

4.     Follow up of home care through a close family member (care taker )

 

 

¢  Relaxation techniques will include selected yoga techniques which will  be taught  for fourteen days for 15-20 minutes daily at yoga hall of AIIA from second day of admission. The  techniques will be:

§  Prayer...OM chanting (30 sec)

§  Sukshma vyayam (warm up) (5min)

§  Asana-Tadasana (1min)

§  Suryanamaskar (4 min)

§  Sukhasana , Paschimottansana,  Savasana (3 min : 1 min each)

§  Pranayama-Nadi Shodhana, Bhramari. (6 min : 3 min each)

§  OM chanting (30 sec)

Investigator had  undergone  short term yoga therapy course (one-month certificate course) and will also seek guidance and help from department of Swastavritta & Yoga of AIIA. 

The practice of relaxation techniques will be suspended if any such condition occurs during the course of Ayurveda treatment and will restart as per instruction from the treating consultant.   

  • Control group – Routine Ayurveda management  will be given to these group.  

 

Data will be collected in following manner :

—  Assessment period

1.      

Baseline assessment

1st / 2nd day of IP admission

2.      

First assessment after structured education , Nursing intervention and relaxation techniques  (F1)

14th / 15th  day during hospitalization period

3.      

Second assessment after structured education and relaxation techniques (F2)

 After 15 days of F1

4.      

Third assessment after structured education and relaxation techniques (F3)

After 30 days of F2

 

Follow up of home care (After discharge) :

a.     Will assign one family member (care taker )  for care of the patient  & treatment compliance  after discharge . Consent will be taken from the family member  (care taker ).

b.     Checklist based on nursing intervention checklist will be given to family member (care taker ) for monitoring the patient at home.

c.     Family member  (care taker ) will maintain a diary  record of different activities and collect pictures of the patient daily activities and will share with the investigator

d.     Researcher Will maintain the contact with the patient and family member (care taker ) over telephone

Primary outcome

Symptomatic Relief in signs and symptoms of Psoriasis

Reduction in Psoriasis Area and Severity Index (PASI) Score.

Improvement in DLQI quality of life      

 

Secondary outcome 

Development of Nursing care protocol and guideline based on Structured  education and relaxation techniques. (Nursing intervention)

 
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