| CTRI Number |
CTRI/2025/12/098598 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of skin disease |
|
Scientific Title of Study
|
Evaluation of effect of agada based treatment protocol in the management of vipadika palmoplantar psoriasis an open labelled clinical trial |
| 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 Harshita Patle |
| Designation |
PG Scholar |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum 590003 Karnataka India |
| Address |
Department of Agada tantra KAHERs Shri BMK Ayurveda mahavidyalay
Shahpur Belgaum 590003 Karnataka India
Belgaum
KARNATAKA
590003
India |
| Phone |
07999545338 |
| Fax |
|
| Email |
patle4852@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rudramma R Hiremath |
| Designation |
Professor |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum 590003 Karnataka India |
| Address |
Department of Agada tantra KAHERs Shri BMK Ayurveda mahavidyalay
Shahpur Belgaum 590003 Karnataka India
Belgaum
KARNATAKA
590003
India |
| Phone |
9480539098 |
| Fax |
|
| Email |
hemalata.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rudramma R Hiremath |
| Designation |
Professor |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belgaum 590003 Karnataka India |
| Address |
Department of Agada tantra KAHERs Shri BMK Ayurveda mahavidyalay
Shahpur Belgaum 590003 Karnataka India
Belgaum
KARNATAKA
590003
India |
| Phone |
9480539098 |
| Fax |
|
| Email |
hemalata.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri BMK Ayurved Mahavidyalaya and hospital Shahpur Belgaum 590003
Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Harshita Patle |
| Address |
Department of Agada tantra KAHERs Shri BMK Ayurveda mahavidyalay
Shahpur Belgaum 590003 Karnataka India |
| Type of Sponsor |
Other [self] |
|
|
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 Harshita Patle |
KLE Hospital and Medical Research centre |
Department of Agada tantra KAHERs Shri BMK Ayurveda mahavidyalay
Shahpur Belgaum 590003 Karnataka India
Belgaum
KARNATAKA |
07999545338
patle4852@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee for Research on Human Subjects KAHERs Shri BM Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Shahapur Belagavi |
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: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dooshivishari Agada, Reference: 11. Ashtanga Hridaya, Uttara Tantra, Chapter 35, Verse 39, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: -(2) Medicine Name: Mahatikataka Ghrita , Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -leukwarm water), Additional Information: -(3) Medicine Name: Jeevantiyadi Yamakam , Reference: Charaka Samhita, Chikitsa Sthana, Chapter 7, Verses 120-121, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 20(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Clinically diagnosed cases of Vipadika as per classical Ayurvedic texts
2 Patients aged between 18 to 60 years irrespective of gender
3 Diagnosed cases of Vipadika palmoplantar psoriasis who are not on any treatment since 1 month
|
|
| ExclusionCriteria |
| Details |
1 Chronic case of Vipadika more than five years
2 Patients with Diabetic Psoriasis vulgaris Erythrodermic pustular or generalized plaque psoriasis i e not limited to palms and soles
3 Presence of systemic illnesses
4 Pregnant or lactating women
5 Patients with known hypersensitivity or allergy to any ingredients of the Agada-based formulation or procedures
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
to assess the subjective parameters like pani pada sphutana kandu daha pidika vedana raga
To assess the impact of Agada based treatment protocol on patient daily life and wellbeing by using Dermatology Life Quality Index DLQI and photographic documentation |
0th 15th 30th 45th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess objective parameter using m PPPASI score |
0th 15th 30th 45th |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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="1"
Months="6"
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
|
not yet recruiting |