| CTRI Number |
CTRI/2023/01/049034 [Registered on: 16/01/2023] Trial Registered Prospectively |
| Last Modified On: |
30/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of Prapunnadadi Cream and Panchatikta Ghrita Verses Polyherbal Cream and Panchatikta Ghrita in the treatment of Ekakushtha (Psoriasis) |
|
Scientific Title of Study
|
Comparative clinical study on the efficacy of Prapunnadadi Cream and Panchatikta Ghrita Verses
Polyherbal 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 |
Mahatma Gandhi Ayurveda College Hospital and Research Center |
| Address |
Datta Meghe Institute of Medical Sciences Mahatma Gandhi Ayurveda College Hospital and Research Center Room no. 30 Opd and Ipd of Kaychikitsa Department
Wardha
MAHARASHTRA
442001
India
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 |
Mahatma Gandhi ayurved college hospital and research centre |
| Address |
Datta Meghe Institute of Medical Sciences Mahatma Gandhi Ayurveda College Hospital and Research Center Room no. 30 Opd andIpd of Kaychikitsa Department
Wardha
MAHARASHTRA
442001
India |
| Phone |
9404337799 |
| Fax |
|
| Email |
ayurrulz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnil Bhoyar |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Center |
| Address |
Datta Meghe Institute of Medical sciences Mahatma Gandhi Ayurveda college hospital and research centre Room nom 30 Opd and Ipd of Kaychikitsa Department
Wardha
MAHARASHTRA
442001
India |
| Phone |
|
| Fax |
|
| Email |
swapnilbhoyar1809@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 Centre |
| 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 Centre Salod Hirapur Wardha 442001 |
Opd and Ipd of Kaychikitsa Department Room no 30 Wardha Maharashtra
Wardha
MAHARASHTRA |
8668841496
swapnilbhoyar1809@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:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: Psoriasis vulgaris, (2) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Polyherbal 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: panchtikta ghrita orally 5ml OD | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Prapunnadadi cream, Reference: Charak Samhita, Kushtha adhyaya, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: panchtikta ghrita orally 5 ml OD |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects Having Cardinal features of 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 |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in PASI score and may reduce recurrence |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
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. |