| CTRI Number |
CTRI/2021/04/033243 [Registered on: 29/04/2021] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Open label Clinical trial] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Result of Psorlyn tablet and Psorlyn oil in Psoriasis(skin disease). |
|
Scientific Title of Study
|
Clinical Study To Evaluate The Efficacy And Safety Of Psorlyn Tablet And Psorlyn Oil In Psoriasis W.S.R. Kitibha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Kumawat |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
PG Department of Kaumarbhritya, National Institute of Ayurveda, Jaipur
85-A, Vikas-Nagar-B, Heerapura, Ajmer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7665980352 |
| Fax |
|
| Email |
drnehakumawat94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar Nagar |
| Designation |
M.D.(Ayu.) , Associate Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
PG Department of Kaumarbhritya, National Institute of Ayurveda, Jaipur
725, Block 9 Vrinda Garden, Jagatpura, Jaipur(Raj.)
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414062099 |
| Fax |
|
| Email |
drrknagar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrinidhi kumar k |
| Designation |
M.D.(Ayu.) Ph.D(Ayu.) Associate Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
PG Department of Kaumarbhritya, National Institute of Ayurveda, Jaipur
C- 32, Gole market, Jwahar nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877151575 |
| Fax |
|
| Email |
ashanidhiacharya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrVasishths Ayuremedies |
| Address |
A-3, Phase 2, Gallops industrial Park Vasna Chacharwadi, Ta. Sanand, Ahmedabad, Gujrat |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Neha Kumawat |
National institute of Ayurveda, Jaipur, Rajasthan |
Madhav Vilas Palace, Amer road jaipur
Jaipur
RAJASTHAN |
7665980352
drnehakumawat94@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:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: Children having classical sign and symptom and diagnosed as psoriasis., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE
|
| Intervention |
Psorlyn tablet & Psorlyn oil |
DOSE -
Psorlyn tablet -1tablet TID (500mg)
LOCAL APPLICATION – Psorlyn oil will be used in adequate amount for two times on affected area, after 10 min. of application Sunlight/UVA lamps expose on affected area for 20 minutes.
Duration: Total duration of the study will be 3 months.
Follow up period - Follow up will be done on every 15 days with the intervention period
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Children age group between 10 – 16 years of either sex.
2. Children having classical sign and symptom and diagnosed as psoriasis.
3. Patient should be capable of obeying the instruction related to course of therapy. |
|
| ExclusionCriteria |
| Details |
1. Patient with k/c/o any chronic systemic illness and allergic disorders.
2. Patient with k/c/o any other chronic skin disorder except psoriasis.
3. Patient not fulfilling the inclusion criteria.
4. Patient/Attendant not willing to give written consent for participation in the research study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Pasi score. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety of trial drug (Tablet Psorlyn & Oil Psorlyn).
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
10/05/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Psoriasis is one of the common, chronic, autoimmune skin disorder is first evident in approximately one third of affected individuals within the first 2 decade of life. When the onset occurring during childhood about 50% have positive family history of the disease and girls are more frequently affected. The mode of transmission is unknown; a multifactorial type of inheritance has been proposed. There is an association with histocompatibility antigens (HLA). Modern medicine science uses coltar, PUVA (Psoralen and ultraviolet A), corticosteroids and anti mitotic drug for the treatment of psoriasis and it has serious systemic side effects like liver, kidney failure, bone marrow depletion etc. Thus our duty to establish a safer and effective line of treatment for human welfare. Ayurveda may provides long lasting effects, results and better life to patient through its uniqueness. Psorlyn tablet and Psorlyn oil are proposed to evaluate the efficacy and utility in treatment of psoriasis. |