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CTRI Number  CTRI/2020/04/024429 [Registered on: 01/04/2020] Trial Registered Prospectively
Last Modified On: 31/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Parisheka(Affusion Sudation Therapy) In Atopic Dermatitis. 
Scientific Title of Study   Randomized Controlled Clinical Study To Evaluate The Efficacy Of Pugadi Kseera Seka In Vataja Charmadala w.s.r To Atopic Dermatitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Renija 
Designation  PG Scholar 
Affiliation  Sri Sri College Of Ayurvedic Science And Research 
Address  OPD NO.9 Department of Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research 21ST KM Kanakapura Road, PO-Udayapura
OPD NO.9 Department of Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research 21ST KM Kanakapura Road, PO-Udayapura
Bangalore Rural
KARNATAKA
560082
India 
Phone  8147304810  
Fax    
Email  renija18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Divyasri R A 
Designation  Professor,Department of Kaumarabhritya 
Affiliation  Sri Sri College Of Ayurvedic Science And Research 
Address  Opd No.9 Department Of Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research 21ST KM Kanakapura Road, PO-Udayapura
Opd No.9 Department Of Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research 21ST KM Kanakapura Road, PO-Udayapura
Bangalore
KARNATAKA
560082
India 
Phone  9448939421  
Fax    
Email  divya_mesha@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Renija 
Designation  PG Scholar 
Affiliation  Sri Sri College Of Ayurvedic Science And Research 
Address  Opd No.9 Department Of Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research 21ST KM Kanakapura Road, PO-Udayapura
Opd No.9 Department Of Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research 21ST KM Kanakapura Road, PO-Udayapura
Bangalore
KARNATAKA
560082
India 
Phone  8147304810  
Fax    
Email  renija18@gmail.com  
 
Source of Monetary or Material Support  
Opd No.9 Department Of Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research 21ST KM Kanakapura Road, PO-Udayapura 
 
Primary Sponsor  
Name  SRI SRI COLLEGE OF AYURVEDIC SC Sri Sri College Of Ayurvedic Science And Research 
Address  Opd No.9 Department Of Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research 21ST KM Kanakapura Road, PO-Udayapura 
Type of Sponsor  Private medical college 
 
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 
Dr Divyasri R A  Sri Sri College Of Ayurvedic Science And Research  Opd No.9 Department of Kaumarabhritya Sri Sri College of Ayurvedic Science & Research 21ST KM Kanakapura Road, PO-Udayapura,Bangalore
Bangalore Rural
KARNATAKA 
9448939421

divya_mesha@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L208||Other atopic dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Panchatiktaka Ghrita Lepa  External Application of Panchatiktaka Ghrita Will be done in patients diagnosed With Atopic Dermatitis daily once For 7 daysFollow up will be done on 14th day and 21st days 
Intervention  Pugadi Ksheera Seka  Ksheerapaka(Milk Decoction) Will be Prepared and Seka(Affusion Sudation) will be done in Patients diagnosed With Atopic Dermatitis once daily For 7 days.Follow up will be done on 14th day and 21st day. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1. Subjects of age group 1 year to 5 years will be included irrespective of religion, gender and socio-economic status.
2. Subjects diagnosed with Lakshanas of Vataja charmadala will be included for the study.
3. Subjects having the clinical features of acute & subacute atopic dermatitis will be included.
 
 
ExclusionCriteria 
Details  1. Subjects below the age of 1 year and above the age of 5 years will be excluded.
2. Chronic atopic dermatitis (more than 1 year duration) will be excluded.
3. Atopic dermatitis associated with secondary bacterial infection, lichenification, oozing from the site of lesion will be excluded.
4. Subjects presenting any other associated systemic symptoms like diarrhoea, acute respiratory infections, acute febrile conditions will be excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Seka(Affusion Sudation) Will help in reducing symptoms of Atopic Dermatitis(Vataja Charmadala)  7 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Panchatikta Ghrita Lepa will have less effect than Pugadi Ksheera Seka in Atopic Dermatitis  7 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 2 
Date of First Enrollment (India)   02/04/2020 
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="1"
Months="6"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   UGC Approved Journals 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Children are easily prone for skin diseases as they have thinner and delicate skin than adults and also due to their sensitive immune system. In pediatric practice, one third of the patients come with complaints of skin diseases, Atopic dermatitis being the most common among the dermatological condition of infancy and early childhood. It is a chronic, inflammatory relapsing skin disorder with varying degree of pruritus and inflammation of skin accompanied by cutaneous physiological dysfunction

It affects the estimated 1-5% of world population, more than 10-20% of children less than 14 years of age. The prevalence of Atopic dermatitis has been increasing over the past few decades in industrialized and developing countries including India especially in younger children .The incidence of Atopic dermatitis is more in children residing in Bangalore which is also the allergy capital of the country because of the increased pollution, dry weather, urbanization etc. 


Social stigma of living with a visible skin condition like Atopic dermatitis affects a child’s social and mental well being, in turn affecting his growth in all dimensions. In modern science there is no specific and effective treatment modality for Atopic dermatitis. Topical steroids applications, anti histamines and moisturizers are commonly used, which makes skin sensitive on regular usage and leads to flaring up of symptoms on discontinuation of treatment. So there is a need to find an effective line of management for this condition.

 

Among the different modalities of treatment mentioned for Vataja charmadala like Pradeha, Lepa, Seka, Abhyanga etc, the effect of Lepa in Vataja Charmadala has been analysed through several studies.  But only few studies are carried out to analyse the effect of Seka (affusion sudation), a type of Drava Sweda in this condition. Hence this study is an effort made to assess the efficacy of Pugadi ksheera seka and Pancha tiktaka gritha lepa in Vataja charmadala.

 
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