| CTRI Number |
CTRI/2024/12/078677 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Durvadya Taila and Kaishor Guggul in Treating Eczema (Vicharchika) |
|
Scientific Title of Study
|
A single arm clinical trial to evaluate the efficacy of Durvadya taila along with kaishor guggul in the management of vicharchika wsr 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 |
Saloni Pawan Shah |
| Designation |
PG SCHOLAR |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner |
| Address |
SST Ayurved Mahavidyalaya, Kayachikitsa OPD no. 5, Front of prasad hotel, pune-nashik highway, Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9420158785 |
| Fax |
|
| Email |
salonishah.shah07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ravin Sundarlal Chandak |
| Designation |
Professor |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner |
| Address |
SST Ayurved Mahavidyalaya, Kayachikitsa OPD no. 5 Front of prasad hotel, pune-nashik highway, Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9822174748 |
| Fax |
|
| Email |
ravinchandak2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saloni Pawan Shah |
| Designation |
PG SCHOLAR |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner |
| Address |
SST Ayurved Mahavidyalaya, Kayachikitsa OPD no. 5 Front of prasad hotel, pune-nashik highway, Sangamner
MAHARASHTRA
422605
India |
| Phone |
9420158785 |
| Fax |
|
| Email |
salonishah.shah07@gmail.com |
|
|
Source of Monetary or Material Support
|
| SST Ayurved Mahavidyalaya, Kayachikitsa OPD no. 5 Front of prasad hotel, pune-nashik highway, Sangamner, dist Ahmadnagar pincode 422605 |
|
|
Primary Sponsor
|
| Name |
SST Ayurved Mahavidyalaya Sangamner |
| Address |
SST Ayurved Mahavidyalaya, Kayachikitsa OPD no. 5 Front of prasad hotel, pune-nashik highway, Sangamner, dist Ahmadnagar pincode 422605 |
| 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 |
| saloni shah |
SST Ayurved Mahavidyalaya |
SST Ayurved Mahavidyalaya, Kayachikitsa OPD no. 5 Front of prasad hotel, pune-nashik highway, Sangamner, dist Ahmadnagar pincode 422605
Ahmadnagar
MAHARASHTRA |
9420158785
salonishah.shah07@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. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Durvadya taila , Reference: kushtarogachikitsa, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: , Reference: kaishor guggul, Route: sharangdhar samhita, Dosage Form: Taila, Dose: 13(500), Frequency: mg, Bhaishajya Kal: bd, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: -warm water |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Pt either sex with the age group between 18-60 years
2. pt diagnosed as vicharchika on the basis of lakshanas like kandu, daha, ruja, pidaka, shyavata, srava, rukshata
3. willing for participation |
|
| ExclusionCriteria |
| Details |
1. pt aged below 18 years and above 60 years will be excluded
2. pregnant & lactating mothers
3. known case of dm, htn, malignancy or pt under any systemic medication
4. pt suffering from any other chronic skin diseases
5. pt with known cases of other debiliting diseases like SLE, TB |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine effect of durvadya taila with kaishor guggul in vicharchika |
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to relief vicharchika by ayurvedic treatment |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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="1" |
|
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
|
it is a single arm clinical trial to evaluate the efficacy of durvadya taila and kaishor guggul in the management of vicharchika eczema age group 18-60 tears male and females |