CTRI Number |
CTRI/2023/06/054474 [Registered on: 27/06/2023] Trial Registered Prospectively |
Last Modified On: |
24/06/2023 |
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 Kushthaghna Mahakashaya and Tutthadi Lepa in Psoriasis |
Scientific Title of Study
|
A Clinical Study to evaluate the efficacy of Kushthaghna Mahakashaya and Tutthadi Lepa in the management of Mandal Kushtha W.S.R Psoriasis |
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 Sheetal Katariya |
Designation |
PG Scholar |
Affiliation |
Madan Mohan Malviya Government Ayurved College |
Address |
PG Scholar
Kayachikitsa Department
Madan Mohan Malviya Government Ayurved College Udaipur
Udaipur RAJASTHAN 313001 India |
Phone |
9799319457 |
Fax |
|
Email |
sheetalkataria1894@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sheetal Katariya |
Designation |
PG Scholar |
Affiliation |
Madan Mohan Malviya Government Ayurved College |
Address |
PG Scholar
Kayachikitsa Department
Madan Mohan Malviya Government Ayurved College Udaipur
Udaipur RAJASTHAN 313001 India |
Phone |
9799319457 |
Fax |
|
Email |
sheetalkataria1894@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ravi Sharma |
Designation |
Proffesor and Head of Deaprtment of Kayachikitsa |
Affiliation |
Madan Mohan Malviya Government Ayurved College |
Address |
Madan Mohan Malviya Government Ayurved College
Udaipur
Rajasthan
Udaipur RAJASTHAN 313001 India |
Phone |
9414419259 |
Fax |
|
Email |
rspgkcj2015@gmail.com |
|
Source of Monetary or Material Support
|
Madan Mohan Malviya Government Ayurved College, Udaipur, Rajasthan |
|
Primary Sponsor
|
Name |
Madan Mohan Malviya Government Ayurved College, Udaipur, Rajasthan |
Address |
Madan Mohan Malaviya Government Ayurved College PG Department of kayachikitsa |
Type of Sponsor |
Government 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 |
Dr Sheetal katariya |
Madan Mohan Malviya Government Ayurved College |
Department of Kayachikitsa OPD no 1 Government Ayurved Hopsital Motichohtta 303001 Udaipur RAJASTHAN |
9799319457
sheetalkataria1894@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee Madan Mohan Malaviya Government Ayurved College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KUSHTHAM, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushthaghna Mahakashaya, Reference: Charak samhitha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Tutthadi lepa, Reference: Charak samhitha, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kushthaghna Mahakashaya, Reference: Charak samhitha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Ptients willing for trial
The patient who age in between 20 year to 60 year
The patient having clinical sign and symptom of Madal Kushtha (Psoriasis)
the patient having complaints less than 5 year duration |
|
ExclusionCriteria |
Details |
Patients below the age of 20 year and above 60 year
Patients with illness more than 5 year
Patient with long term steroid and cytotoxic treatment taking more than 5 year
Patient having concomitant iliiness like Diabeted Mallitus AIDS and other auto immune disorder
patient with evidence of any malignancy are exluded
Any drud addiction if present are excluded
Pregnant and lactatic women are excluded |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1)Improvement in the signs and symptoms of Mandal kushtha
2)Reduction in the PASI score |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
1)Improvement in signs & symptoms of Mandal kushtha
2)Reduction in the PASI score |
2 weeks,4 weeks,6 weeks,8 weeks & 10 weeks |
|
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
|
N/A |
Date of First Enrollment (India)
|
15/07/2023 |
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="0" Months="3" 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
|
This study is about evaluate the efficacy of Kushthaghna Mahakashaya and Tutthadi Lepa in the management of Mandal kushtha with special reference to Psoriasis. This is a Double- arm study 20 patients will be given Kushthaghna Mahakashaya in the form of Kashaya/Kwatha in the quantity of 10 gm twice a day before meal for 90 days 20 patients will be given Kushthaghna Mahakashaya in the form of Kashaya/Kwatha in the quantity of 10 gm twice a day before meal along with Tutthadi Lepain the quantity of 10 gm twice a day after meal for 90 days follow up - 15 days gap during trail period |