| CTRI Number |
CTRI/2021/12/038972 [Registered on: 28/12/2021] Trial Registered Prospectively |
| Last Modified On: |
27/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Prapunnadadi cream in the treatment of Ekakushtha |
|
Scientific Title of Study
|
Comparative clinical study on the efficacy of Prapunnadadi Cream and
Panchatikta Ghrita Verses Atrisor Cream and Panchatikta Ghrita in the
management of Ekakushtha Psoriasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swapnil Bhoyar |
| Designation |
pg scholar |
| Affiliation |
datta meghe institute of medical science |
| Address |
room no 30 department of Kayachikitsa Mahatma gandhi ayurved college hospital and research center salod wardha
room no 30 department of Kayachikitsa Mahatma gandhi ayurved college hospital and research center salod wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8668841496 |
| Fax |
|
| Email |
swapnilbhoyar1809@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sourabh Deshmukh |
| Designation |
Associate Professor |
| Affiliation |
datta meghe institute of medical sciences |
| Address |
Room No 30 Department of Kayachikitsa Mahatma gandhi ayurved college hospital and research center
Room no 30Department of Kayachikitsa Mahatma gandhi ayurved college hospital and research center
Wardha
MAHARASHTRA
442001
India |
| Phone |
9404337799 |
| Fax |
|
| Email |
ayurrulz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sourabh Deshmukh |
| Designation |
Associate Professor |
| Affiliation |
datta meghe institute of medical sciences |
| Address |
Room no 30 Department of Kayachikitsa Mahatma gandhi ayurved college hospital and research center
Room no 30 Department of Kayachikitsa Mahatma gandhi ayurved college hospital and research center
Wardha
MAHARASHTRA
442001
India |
| Phone |
9404337799 |
| Fax |
|
| Email |
ayurrulz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma gandhi ayurved college hospital and research center salod wardha |
|
|
Primary Sponsor
|
| Name |
Mahatma gandhi ayurved college hospital and research center |
| Address |
room no 30 department of Kayachikitsa Mahatma gandhi ayurved college hospital and research center salod wardha |
| 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 Swapnil Bhoyar |
Mahatma gandhi ayurved college hospital and research center |
Room no 30 Department of kayachikitsa Mahatma gandhi ayurved college hospital and research center
Wardha
MAHARASHTRA |
8668841496
swapnilbhoyar1809@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma gandhi ayurved college hospital and research center institutional ethics committee salod wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: prapunnadadi cream, Reference: charak samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: internally panchtikta ghrita 5ml twice daily | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Atrisor cream, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: internally panchtikta ghrita 5 ml twice daily |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects Having Cardinal features ok Ekakushtha
Aswedanam
Mahavastu
Matsyashaklopamam
Kandu
Mild to Moderate Psoriasis according to PASI Scale |
|
| ExclusionCriteria |
| Details |
Diagnosed diseases like Diabetes Mellitus Cancer AIDS and Tuberculosis
Subject of other dermatological infectious conditions
Pregnant or lactating women
Severe Psoriasis Cases according to PASI Scale
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Prapunnadadi cream and Panchatikta ghrita on absent sweating, spread over large area of body, fishy scales, itching |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Prapunnadadi cream and panchatikta ghrita on pasi scale in Ekakushtha |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
22/02/2022 |
| 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)?
Response - NO
|
|
Brief Summary
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computerized generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done.After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups.The trial is a parallel-group, randomized, open label, standard - controlled trial. It will include, a 30 days treatment period, and a 0th, 15th 30th day follow-up period. |