| CTRI Number |
CTRI/2024/04/065046 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of khadirastak kwatha and manjisthadi taila(external application) in treatment of psoriasis |
|
Scientific Title of Study
|
Clinical Evaluation of Khadirastaka Kvatha and Local Application of Manjisthadi 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 Feni R Patel |
| Designation |
PG Scholar |
| Affiliation |
J.S.Ayurved Mahavidyalay |
| Address |
Department of Kayachikitsa J S Ayurved Mahavidyalaya and P D Patel Ayurved Hospital college road kheda nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8758189589 |
| Fax |
|
| Email |
fenipatel676@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Manish Patel |
| Designation |
Professor and HOD |
| Affiliation |
J.S.Ayurved Mahavidyalay |
| Address |
Department of Kayachikitsa J S Ayurved Mahavidyalaya and P D Patel Ayurved Hospital college road kheda nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Manish Patel |
| Designation |
Professor and HOD |
| Affiliation |
J.S.Ayurved Mahavidyalay |
| Address |
Department of Kayachikitsa J S Ayurved Mahavidyalaya and P D Patel Ayurved Hospital college road kheda nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
|
Source of Monetary or Material Support
|
| sundar ayurved pharmacy, J S ayurved mahavidyalay and P D patel ayurved hospital,college road,Nadiad-387001 |
|
|
Primary Sponsor
|
| Name |
J S Ayurved Mahavidhyalay |
| Address |
J S Ayurved Mahavidyalay, college road, nadiad 387001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| J S Ayurved Mahavidhyalay |
J S Ayurved Mahavidyalay, college road, nadiad,387001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Feni R Patel |
J S Ayurved mahavidyalay |
Department of kayachikitsa J S Ayurved Mahavidyalay P D Patel ayurved Hospital
Kheda
GUJARAT |
8758189589
fenipatel676@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC for human research |
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: khadirastak kwatha, Reference: yogaratnakar kustha chikitsaa 63, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -(2) Medicine Name: manjisthadi taila, Reference: yogaratnakar kustha chikitsa 142, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients will be diagnosed with psoriasis with the help of presence of signs and symptoms like scaling(dalana),itching(kandu),erythema (krusna aruna varna),loss of perspiration (asvedanam),dryness(rukshta),auspitz sign,candle grease sign,koebners phenomenon |
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating females.
2.Patients who have taken medicine of corticosteroid drugs or immune-suppressants or other biological medicines within last 6 months.
3.Known case of diseases like AIDS, STD, TB, heart diseases and other disorders which lead to fetal condition for the patients.
4.Patients having diabetes mellitus.
5.Other concomitant skin disease occurring with allergic reaction of any other disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe and find out changes in signs and symptoms of the psoriasis after the oral administration of khadirastaka kwatha and local application of manjisthadi taila. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the changes in PASI index in the patients of psoriasis.
2.To find out the improvement in quality of life through changes in DLQI in the patients of psoriasis.
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
24/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This will be submitted in form of dissertation |
|
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 a complex, chronic, multifactorial, inflammatory disease that involves hyper proliferation of keratinocytes in the epidermis, with an increase in the epidermal cell turnover rate. 20 patients of psoriasis who fulfill the inclusion criteria were selected from OPD and gave them oral administration of khadirastak kwatha 40 ml twice a day and manjisthadi taila for local application twice a day. Patients were treated for 8 weeks and assessed before and after the treatment. It shows significant effect in all symptoms as well as PASI and DLQI. |