| CTRI Number |
CTRI/2022/02/040618 [Registered on: 25/02/2022] Trial Registered Prospectively |
| Last Modified On: |
12/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Effect of kushthadi churna and its ointment in the management of eczema"
eczema" |
|
Scientific Title of Study
|
"Pharmaceutico-clinical study of Kushthadi Churna and its ointment and their efficacy in the management of Vicharchika" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Ashfak |
| Designation |
PG scholar |
| Affiliation |
All India institute of Ayurveda |
| Address |
Room no. 220,RSBK department,Academic block, All India institute of Ayurveda, Mathura Rd, Gautam Puri, Sarita Vihar, New Delhi, Delhi 110076
South
DELHI
110076
India |
| Phone |
7891987467 |
| Fax |
|
| Email |
sheikhashfaq555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod R Yadav |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 212,RSBK department,Academic block, All India institute of Ayurveda, Mathura Rd, Gautam Puri, Sarita Vihar, New Delhi, Delhi
South
DELHI
110076
India |
| Phone |
8930625596 |
| Fax |
|
| Email |
drpramod88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod R Yadav |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 212, RSBK department, Academic block, All India institute of Ayurveda, Mathura Rd, Gautam Puri, Sarita Vihar, New Delhi, Delhi
South
DELHI
110076
India |
| Phone |
8930625596 |
| Fax |
|
| Email |
drpramod88@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of Ayurved, New delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda Director |
| Address |
All India institute of Ayurveda(AIIA) , Mathura Rd, Gautam Puri, Sarita Vihar, New Delhi, 110076
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mohd Ashfak |
All India institute of Ayurveda |
OPD No. 08, Ground floor, Hospital Block,All India institute of Ayurveda, Mathura Rd, Gautam Puri, Sarita Vihar, New Delhi,110076
South
DELHI |
7891987467
sheikhashfaq555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, (2) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kushthadi Churna |
Patient will be provided with Kushthadi Churna for local dusting after application of Sarshapa Taila (Quantity Sufficient 2-3 time/day) with
starch tablet 500mg BD with
water for 28 days follow up |
| Intervention |
Kushthadi Churna Ointment |
Patient will be given local application of Kushthadi Churna Ointment (Quantity Sufficient 2-3 times/day) with starch tablet 500mg BD with
water for 28 days follow up |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having classical clinical features of Vicharhcika
a. Kandu
b. Pidika
c. Shyavavarnata
d. Bahusravah/Rukshtaka
e. Raga
f. Daha
2 Duration of the disease: Chronicity for less than 2 years, recurrent in nature and or not responding to conventional therapy.
3 Mild to moderate cases of eczema as per EASI.
|
|
| ExclusionCriteria |
| Details |
1 Age below 30 years and above 60 years.
2 Severe cases of eczema as per EASI.
3 Patients under long standing medication, suffering from systemic or linked disease.
4 Pregnant and lactating women.
5 Chronicity more than 2 years.
6 Patients with acute and chronic systemic and metabolic disorders.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SOP and efficacy of Kushthadi Churna and its ointment would be established. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will provide the analytical profile and shelf life of Kushthadi Churna ointment |
28 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2022 |
| Date of Study Completion (India) |
20/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Different types and stages of eczema affect 31.6 million people in the United States, which equals more than 10% of the population.Vicharchika(Eczema) is a condition in which patches of skin become inflamed, itchy, cracked, and rough. Some types can also cause blisters. Acharyas has mentioned that, external applications form the best way to treat Kushtha. Application of dusting enters in to Romakupa and further gets absorbed through svedavahi srotas and siramukha leading to desired effects. This method of rubbing increases the skin temperature which might be hastening the pilosebaceous uptake and skin permeation of the drug in topical formulation. classical formulations also have some drawbacks which are not feasible in busy life style during this modern era. Now a days different herbal modern dosage forms are widely accepted because of its feasibility, effectiveness and also these are easy to carry. Therefore, it has been postulated to convert Kushthadi Churna into ointment form in the present work. Kushthadi Churna ointment will be prepared by khushthadi churna and will be local application in patients of Vicharchika( Eczema) to evaluate its effectiveness |