| CTRI Number |
CTRI/2024/05/067843 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Interventional Study To Evaluate The Effect Of An Ayurvedic Tablet, Cream And Purgative Therapy On The Participants Of Psoriasis(Skin Condition) |
|
Scientific Title of Study
|
A Single Arm Open Label Clinical Study To Evalute The Efficacy Of Khadira-Triphaladi Kasaya Ghanvati And Aragvadha Cream With Mridu Virechan In The Management Of Psoriasis In Children. |
| 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 Vishal N Prajapati |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of Kaumarbhritya, Room no 222, National Institute of Ayurveda, Deemed to be University, Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
8169436681 |
| Fax |
|
| Email |
vish123go@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vishal N Prajapati |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of Kaumarbhritya, Room no 222, National Institute of Ayurveda, Deemed to be University, Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
8169436681 |
| Fax |
|
| Email |
vish123go@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Krishna Sharma |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of Kaumarbhritya, Room no 222, National Institute of Ayurveda, Deemed to be University, Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
8058673146 |
| Fax |
|
| Email |
krishubaag1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vice Chancellor of National Institute of Ayurveda Jaipur, Amer road, pin code 302002, Jaipur, Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
NO SPONSER |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Krishna Sharma |
National Institute of Ayurveda, Jaipur |
Kaumarbhritya Department,
OPD NO. 5 Jaipur RAJASTHAN |
8058673146
krishubaag1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadira-Triphaladi Kashaya Ghanvati, Reference: Sahasrayogam of Dr. Ramniwas Sharma & Dr. Surendra Sharma published by Chaukhambha 2014th edition page no 286, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -(2) Medicine Name: Aragvadha Cream, Reference: Yogatarangini of Trimalla Bhatta by dr. Nirmal Saxena published by chaukhamba Sanskrit Bhawan edi 2017 kushta roga 62/11 page no 332, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Dose- Quantity Sufficient..Dosage Form- Cream |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of either sex in between age group of 10 to 16 years.
2.Patients presenting with clinical features of psoriasis.
3.Mild to Moderate psoriasis in affected area according to PASI Scale (1-69%)
4.Patient should be capable of obeying the instruction related to course of therapy
|
|
| ExclusionCriteria |
| Details |
1.Severe psoriasis in affected area according to PASI scale. (more than 70%)
2.Known case of Acute/Chronic Eczema and Leprosy.
3.Development of any allergic or hypersensitive signs and symptoms during the trial period (due to trialdrug).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Change in the scoring/grading of symptom of psoriasis in PASI scale |
4 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in the APso-QOL parameter
2.To evaluate the safety of trial drug (Khadira- Triphaladi Kasaya Ghanvati and Aragvadha Cream)
|
4 months |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/06/2024 |
| Date of Study Completion (India) |
16/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Sharma K, Prajapati VN, Nagar RK, Role of KhadiraTriphaladi Kashaya in the management of Plaque
Psoriasis: A Review. J Ayu Int Med Sci.
2025;10(4):245-254.
Available From
https://jaims.in/jaims/article/view/4611/ |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In
this study 34 patients were enrolled, of whom 30 successfully completed the
trial, while 4 participants discontinued during the study. The study population
was recruited from the Outpatient Department (O.P.D.) of the Department
of Balroga at the National Institute of Ayurveda. The
diagnosis of study subjects was confirmed either through pre-existing clinical
diagnoses of psoriasis or by screening individuals with clinical features of
psoriasis using the PASI scale.Most patients belonged to the lower-middle
socioeconomic class (44.12%) and practiced Hinduism (64.7%). Regarding personal
habits, 85.3% had good appetite, 94.2% maintained proper sleep, and 61.8% had
regular bowel movements. Dietary patterns showed a predominance of Madhura
Rasa–dominant food (55.9%) and Viruddha Ahara consumption
(73.5%), with 47.06% consuming fast food twice weekly. The majority of patients
had Vata–Kapha prakriti (64.7%), 41.18% exhibited Tvaka
Sara, 53.33% had Avara Sattva, 85.29% had Pravara Ahar
Shakti, and 70.59% displayed Madhyama Jarana Shakti. Following
therapy, the mean PASI score decreased from 17.33 to 4.27, the APso-PI score
from 13.87 to 4.00, and the APso-PST score from 14.33 to 4.53. These changes
were highly significant (P < 0.001), confirming the effectiveness of the
intervention in alleviating the clinical manifestations of psoriasis and
improving patients’ quality of life. |