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
|
|
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
|
|
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. |