| CTRI Number |
CTRI/2024/07/071541 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing herbal formulations - Srestakhadiradi kashaya and Aragvadadhi kashaya after purgation therapy in the treatment of Eczema |
|
Scientific Title of Study
|
An open label randomised comparative clinical study to evaluate the efficacy of Srestakhdiradhi kashaya and Aragvadhadhi kashaya after Virechana in the management of Vicharchika vis-a-vis Eczema |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushmitha N G |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of PG Studies in Kayachikitsa OPD no 1 JSS Ayurveda Medical College and Hospital Kayachikitsa
41 E Lalitadripura Road Alanahalli Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
7090052752 |
| Fax |
|
| Email |
sushmitha0477@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa C Patil |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of PG Studies in Kayachikitsa OPD no 1 JSS Ayurveda Medical College and Hospital Kayachikitsa
41 E Lalitadripura Road Alanahalli Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9886485005 |
| Fax |
|
| Email |
deepsmysore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushmitha N G |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of PG Studies in Kayachikitsa OPD no 1 JSS Ayurveda Medical College and Hospital Kayachikitsa
41 E Lalitadripura Road Alanahalli Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
7090052753 |
| Fax |
|
| Email |
sushmitha0477@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aragvadhadi Kashaya will be Procured from Pharmacy of Jss Ayurveda Medical college and Hospital 41E Lalithadripura road Alanahalli Mysore, Karnataka-570028, India |
| Shrestakadiradhi kashaya will be prepared from GMP certified pharmacy Arya vaidya shala, Malappuram dist , Kerala-676503, India |
|
|
Primary Sponsor
|
| Name |
Dr Sushmitha N G |
| Address |
2nd Year PG Scholar Department of PG Studies in Kayachikitsa OPD no 1 JSS Ayurveda Medical College and Hospital Kayachikitsa
41 E Lalitadripura Road Alanahalli Mysuru-570028 |
| Type of Sponsor |
Other [self] |
|
|
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 Sushmitha N G |
JSS Ayurveda Hospital |
Department of PG Studies in Kayachikitsa
OPD no 1
41 E Lalitadripura Road Alanahalli Mysuru-570028
Mysore
KARNATAKA |
7090052753
sushmitha0477@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L208||Other atopic dermatitis. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shrestakadiradi kashaya, Reference: sahasra yoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Argavadadhi kashaya, Reference: asthanga hridaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases of Vicharchika Vis-a-Vis Eczema Classical signs and symptoms
2.Subjects having age between 18 to 60 years irrespective of gender religion Socio economic status
3.Patients fit for Virechana Karma
|
|
| ExclusionCriteria |
| Details |
1.Subjects with diagnosed cases of uncontrolled DM ,HTN or other systemic disorders which interferes with the course of treatment
2.Subjects with other associated skin disorder scabies, Ichthyosis, cutaneous T-cell Lymphoma, Psoriasis, Photodermatoses, Immune deficiency syndromes , Erythroderma, Lichen planus
3.Pregnant women and lactating mother
4.Patients on oral corticosteroid treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Srestakhadiradhi Kashaya and Aragvadhadi kashaya after Virechana in the management of Vicharchika vis-a-vis Eczema |
Pre test-0th day
Mid test-After virechana-(9-17 days)
Post test-After shamanaousudhi(60-68 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Srestakhadiradhi Kashaya after Virechana in the Management of Vicharchika vis-a-vis Eczema.
To evaluate the efficacy of Aragvadhadi Kashaya after Virechana in the management of Vicharchika vis-a-vis Eczema.
|
Pre test-0th day
Mid test-After virechana-(9-17 days)
Post test-After shamanaousudhi(60-68 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 3 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vicharchika is a type of Kshudra Kusta ,with specific characters like Daha, Kandu, Srava, and Pidaka , mainly due to vitiation of Kapha and Pitta Doshas. These features stimulates the typical clinical manifestation of eczema which are itching, scaling, redness and oozing vesicular lesions which become crusted or hardened. Eczema is a common disease and a survey explored the incidence of one in ten among the general population.In the management of Vicharchika, Acharyas have mentioned different Shodhana Karmas. Virechana Karma is a type of Shodhana, in which vitiated Pitta and Kapha Doshas are expelled through Adhomarga.
In present scenario it is more oftenly exacerbated with Psychological and social impact. Hence is the need of time to find out safe and effective treatment for Vicharchika vis-Ã -vis Eczema. In Ayurveda, AcharyaCharakaexplained Snehapana, Vamana, Virechana,Raktamokshana as line of treatment for Kushta .Srestakhadiradhi kashaya is one of the formulation mentioned in Sahasrayoga for the treatment of Kushta(. Thus the present study is designed to evaluate the efficacy of Shrestakadhiradi Kashaya after virechana in the management of Vicharchika . |