| CTRI Number |
CTRI/2025/07/090404 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Psorogrit and Divya Taila in Subject suffering from Psoriasis |
|
Scientific Title of Study
|
A Prospective, Open-Label, Single Arm, Observational Study on The Clinical Effectiveness of Psorogrit, and Divya Taila in the Management of 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 Ajay Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Ayurveda Hospital |
| Address |
OPD No 31
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9039402300 |
| Fax |
|
| Email |
drajaysingh82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Ayurveda Hospital |
| Address |
OPD No 31
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar Uttarakhand
UTTARANCHAL
249405
India |
| Phone |
9039402300 |
| Fax |
|
| Email |
drajaysingh82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Ayurveda Hospital |
| Address |
OPD No 31
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar Uttarakhand
UTTARANCHAL
249405
India |
| Phone |
9039402300 |
| Fax |
|
| Email |
drajaysingh82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation Governed by Patanjali Research Foundation Trust NH 58 Near Bahadrabad Haridwar Uttarakhand 249405 India |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation |
| Address |
NH 58 Near Bahadrabad Haridwar Uttarakhand 249405 India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Singh |
Patanjali Ayurveda Hospital |
OPD No 31 Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
9039402300
drajaysingh82@gmail.com |
| Dr Ajay Singh |
Patanjali Wellness |
OPD No 17 Department of Panchkarma Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
9039402300
drajaysingh82@gmail.com |
| Dr Ajay Singh |
Patanjali Yoggram |
OPD No 13 Department of Panchkarma Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar 249402 Uttarakhand India
Hardwar
UTTARANCHAL |
9039402300
drajaysingh82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Psorogrit, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 540(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -With Lukewarm Water), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Divya Taila, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
PASI score more than 10 percent
Participants who is willingly to participate and give written informed consent.
Participants who are willing to undergo 3 months of treatment will be included.
|
|
| ExclusionCriteria |
| Details |
Participants who are not willing to participate.
Participants with a personal or family history of premalignant or malignant skin tumors.
Pregnant lactating and planning for pregnancy.
Participants with serious comorbid conditions like renal hepatic and severe cardiac disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The area and severity of psoriasis will be measured by using the Psoriasis Area and Severity Index score. |
At baseline and after Day 30 Day 60 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The quality of life of patients with psoriasis will be assessed by using the Dermatology Life Quality Index score. |
At baseline and after Day 30 Day 60 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
16/07/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a
prospective, open-label, single-arm, observational study. Subjects will be
screened on the basis of Inclusion/Exclusion criteria and enrolled after
obtaining written Informed consent. After enrollment, Subjects will
take Psorogrit orally and local application of Divya Taila to the affected
areas for 3 months The area and severity of psoriasis will be measured at
baseline and reassessed after 30, 60, and 90 days using the Psoriasis Area and
Severity Index (PASI) score. The quality of life will be assessed at baseline
and subsequently evaluated for changes after 30, 60, and 90 days of treatment
using the Dermatology Life Quality Index (DLQI) score.
|