CTRI Number |
CTRI/2020/02/023491 [Registered on: 21/02/2020] Trial Registered Prospectively |
Last Modified On: |
20/02/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Preventive |
Study Design |
Single Arm Study |
Public Title of Study
|
Effect of Panchatikta Ghrita and Gandhakadya Malahara on Tvakavikara |
Scientific Title of Study
|
Clinical Evaluation of Panchatikta Ghrita and Gandhakadya Malahara in the management of Vicharchika (Eczema) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Anil Avhad |
Designation |
Research Officer (Ayurveda) |
Affiliation |
Regional Ayurveda Research Institute for Skin Disorders |
Address |
Regional Ayurveda Research Institute for Skin Disorders, Girdharnagar, Asarwa, Ahmedabad
Ahmadabad GUJARAT 380004 India |
Phone |
|
Fax |
|
Email |
dranil.avhad@gov.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr BS Sharma |
Designation |
Research Officer (Ayurvedea) |
Affiliation |
Central Council for Research in Ayurvedic Sciences |
Address |
Central Council for Research in Ayurvedic Sciences, Janakpuri, New Delhi
New Delhi DELHI 110058 India |
Phone |
|
Fax |
|
Email |
bss_ro@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Kiran S Deshbhratar |
Designation |
Assistant Director Incharge |
Affiliation |
Regional Ayurveda Research Institute for Skin Disorders |
Address |
Regional Ayurveda Research Institute for Skin Disorders, Girdharnagar, Asarwa, Ahmedabad
Ahmadabad GUJARAT 380004 India |
Phone |
|
Fax |
|
Email |
rarisd.ahmedabad@gmail.com |
|
Source of Monetary or Material Support
|
Regional Ayurveda Research Institute for Skin Disorders, Ahmedabad |
|
Primary Sponsor
|
Name |
Central Council for Research In Ayurvedic Sciences CCRAS |
Address |
Jawahar lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, No. 61-65, Institutional Area, Opp. 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 Anil Avhad |
Regional Ayurveda Research Institute for Skin Disorders, Ahmedabad |
Block A and D, Second Floor, Bahumali Bhavan, Asarwa, Ahmedabad - 380004 Ahmadabad GUJARAT |
9510176085
dranil.avhad@gov.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics committee of Regional Ayurveda Research Institute for Skin Disorders, Ahmedabad |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L20||Atopic dermatitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Gandhakadya Malahara
(AFI - II) |
5 gm BD external application twice a day for 12 weeks |
Comparator Agent |
Not Applicable |
Not Applicable |
Intervention |
Panchatikta Ghrita
(API part- II, Vol - I) |
6 gm BD orally twice a day before food with luke warm water for 12 weeks |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Known Cases of eczema (based on Hanifin and Rajka criteria for Atopic Dermatitis/ Atopic eczema)
2. Patients willing to participate in the study
|
|
ExclusionCriteria |
Details |
1. Patients with status eczematous condition
2. patients with uncontrolled hypertensiona dn Diebetes Mellitus
3. Known cases of HIV, malignancy
4. Patients having history of Atrial Fibrilliation, Acute coronary syndrome, myocardial infarction, stroke etc in the last 6 months
5. patients on medication with corticosteroids, phototherapy, biologics, antidepressants etc that can have an influence on the outcome of the study
6. Pregnant/lactating women
7. Patients participating in any other clinical trial |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Changes in Eczema Area Severity Index Score (EASI) |
84 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Changes in clinical sign and symptoms as per Ayurvedic classics
2. Changes in patient Oriented Eczema measure (POEM)
3. Changes in Dermatology life Quality Index (DLQI) questionnaire |
3 months |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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/ Phase 3 |
Date of First Enrollment (India)
|
03/01/2020 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The skin is the outermost covering of the body which acts as a protective
barrier. But very often, it is exposed to many entitites which can damage it
and may cause many of the skin disorders. About 10-20% of the general practice
includes the patients suffering from skin diseases1. In Ayurveda,
Vicharchika has been discussed under the heading of Kshudra koshtha both by
Acharya Charaka and Acharya Sushruta. The general causative factors described
here are intake of mutually contraindicated foods, suppression of natural
urges, intake of uncooked food, transgression of the prescribed order with
reference to heat and cold etc. the symptoms described in Samhita are blackish
brown eruptions associated with itching sensation and excessive exudation. The
lines of treatment generally being described for all Kustha (Skin disorders)
including both Panchakarma and oral medication. Vicharchika being one among
kshudra kustha, is also a rasa, raktha and mamsa dhatu pradoshaja vikara2.
All the clinical features of Vicharchika can be very well correlated to clinical
features of Eczema, which is a distinctive pattern of inflammatory response of
the skin, induced by a wide range of external and internal factors acting
singly or in combination.3 It includes the effect of various
microorganisms, vast external environment, complex endocrine and metabolic
transaction within the body and undue stress4. The condition can impact
considerably on the quality of life of the affected individual by causing
physical discomfort, emotional distress, sleep disturbance, restriction of
domestic and social activities and by imposing extra financial costs, as it
will become a socially disagreeable condition. So to manage this condition,
snehana therapy of both bahya and anhyantara sneha was planned. Abhyantara
sneha in the form of shaman sneha acts by normalizing the aggravated doshas,
both of pitta pradhana and vata kapha pradhana conditions, without expelling
them and without disturbing the normal doshas.5 it increases bala
and Varna of dahtus6. Bahya sneha reduces the rookshata of twak
which in turn may help in reducing the local inflammation and so the snigdhata
and varna of twacha may be improved. Hence the present study was intended to
assess the efficacy of Panchatikta Ghrita as shaman sneha along with the
external application of Gandhkadya Malahara in Vicharchika vis-Ã -vis Eczema.
|