| CTRI Number |
CTRI/2025/12/098374 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Dhatturadi Taila and Vipadikahar Ghrita Taila in Vipadika. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Dhatturadi Taila as compared to the efficacy of Vipadikahar Ghrita Taila in Vipadika. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ADITYA YUVRAJ HATWAR |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda, Goa |
| Address |
Room no 102, PG Hostel, All India Institute of Ayurveda, Dhargal, Goa - 403513
North Goa
GOA
403513
India |
| Phone |
08788415367 |
| Fax |
|
| Email |
ahatwar01academic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Narayan Gramopadhye |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda, Goa |
| Address |
Department of Agada Tantra, First Floor, Academic Block, All India Institute of Ayurveda, Dhargal, Goa. 403513
North Goa
GOA
403513
India |
| Phone |
9423272806 |
| Fax |
|
| Email |
nggramo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ADITYA YUVRAJ HATWAR |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda, Goa |
| Address |
Department of Agada Tantra, First Floor, Academic Block, All India Institute of Ayurveda, Dhargal, Goa. 403513
North Goa
GOA
403513
India |
| Phone |
08788415367 |
| Fax |
|
| Email |
ahatwar01academic@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Dhargal, Goa |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda Dhargal Goa |
| Address |
Academic Block, All India Institute of Ayurveda, Dhargal, Goa. 403513 |
| Type of Sponsor |
Other [MD Dissertation ] |
|
|
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 |
| Prof Dr Narayan Gramopadhye |
All India Institute of Ayurveda, Goa |
Hospital Block, All India Institute of Ayurveda, Dhargal, Goa. 403513
North Goa
GOA |
09423272806
nggramo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, All India Institute of Ayurveda, Goa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L408||Other psoriasis. Ayurveda Condition: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vipadikahar Ghrita Taila , Reference: Charak Chikitsa 7/120-122, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatturadi Taila , Reference: Yogaratnakar KushtaChikitsa /182, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Abhakta, 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 patients with Vipadika as per WHO TM2 SN9Y.
2)Patients of the 18 to 60 years of age group of any Gender, Religion, socio-economic status, or Geographical area.
3)Mild to Moderate cases of Vipadika having any 2 cardinal symptoms of Vipadika
ie Panipadasphutanam, manda kandu, tivra Vedana, rukshata
4)Patients with m-PPPASI less than or equal to 50
5)Patients with DLQI less than or equal to 21
6)Patients with NRS less than or equal to 7
7)Participants who have discontinued allopathic treatment at least two weeks before. (Washout Period More than or Equal to 2 weeks)
8)Symptoms for at least 3 months
9)Able to comply with all study procedures for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1)Patients already diagnosed with Uncontrolled Diabetes
2)Children, Pregnant and Lactating Women
3)Immunocompromised patients (e.g. HIV infection, Hepatitis)
4)Patients having other associated skin disorders
5)Patients who have sensitivity reactions to the medicated oils
6)Vipadika skin disease with secondary infections
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in signs and symptoms of Vipadika using Dhatturadi Taila and Vipadikahar Ghrita Taila.
Assessed through modified Palmoplantar psoriasis area severity index score, numerical rating scale, dermatological life quality index. |
0 week 2 week 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the m-PPPASI scores |
0 week 2 week 4 week |
| Changes in the Dermatological Life Quality Index |
0 week & 4 week |
| Changes in NRS |
o week 2 week & 4 week |
| Changes in Subjective & Objective Parameters |
0 week 2 week & 4 week |
| History of potential Dooshivisha Exposure in cases of Vipadika |
0 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/01/2026 |
| 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
|
Current management strategies for
palmoplantar psoriasis involve topical treatments (corticosteroids), Phototherapy
- Psoralen And Ultraviolet A (PUVA), systemic immunomodulators
(Ciclosporin, Azathioprine, Methotrexate, etc), and biologic agents
(Infliximab, Ustekinumab, etc), however, these approaches often come with limitations like a
relapse of the skin lesions after discontinuing the treatment, the potential to
create skin cancer, melanomas, high cost, and potential immunosuppressive side
effects.
Acharya Sushruta has
mentioned Kushta as one of the complications of Dooshivisha. Hence, an effort is needed to look for Dooshivisha hetu
among patients with Kushta with special reference to Vipadika.
Hence, this is an effort
to evaluate the efficacy of the external application of Dhatturadi Taila
for chronic skin conditions such as Vipadika
in a Controlled Clinical Trial along with Dooshivisha hetu among the
patients with vipadika. |