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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  
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 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  
Status 
Not Applicable 
 
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-à-vis Eczema.

 
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