| CTRI Number |
CTRI/2025/04/084881 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| 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
|
A Clinical Study Of Efficacy Of Vipadikahar Ghrit Tail in Vipadika With And Without Dushivishari Agad A Randomized Controlled Trial |
|
Scientific Title of Study
|
Assessing The Efficacy Of Vipadikahar Ghrit Tail in Vipadika With & Without Dushivishari Agad: A Randomized Controlled Trial |
| Trial Acronym |
. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagriti Kumari |
| Designation |
MD (Ay.) Scholar (Agadtantra) |
| Affiliation |
Government Ayurvedic College Patna |
| Address |
Department of Agada Tantra evam Vidhi Vaidyaka,OPD Room
no-16 Government Ayurvedic College and Hospital near
budhmurti Kadamkuan patna
Patna
BIHAR
800003
India
Patna
BIHAR
800003
India |
| Phone |
9608062920 |
| Fax |
|
| Email |
drjagriti2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinbandhu Kumar Kanavjiya |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College Patna |
| Address |
Department of Agada Tantra evam Vidhi Vaidyaka,OPD Room
no-16 Government Ayurvedic College and Hospital near
budhmurti Kadamkuan patna
Patna
BIHAR
800003
India
Patna
BIHAR
800003
India |
| Phone |
7277877176 |
| Fax |
|
| Email |
deenbandhu09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinbandhu Kumar Kanavjiya |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College Patna |
| Address |
Department of Agada Tantra evam Vidhi Vaidyaka,OPD Room
no-16 Government Ayurvedic College and Hospital near
budhmurti Kadamkuan patna
Patna
BIHAR
800003
India
Patna
BIHAR
800003
India |
| Phone |
7277877176 |
| Fax |
|
| Email |
deenbandhu09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurvedic college and hospital kadamkaun patna Bihar 800003
|
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna Bihar |
| Address |
Department of Agada Tantra evam Vidhi Vaidyaka Government
Ayurvedic College and Hospital Patna Aryabhatta Knowledge
University Patna Bihar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jagriti Kumari |
Government Ayurvedic College and Hospital Patna Bihar |
Department of
agadatantra evam Vidhi
Vaidvaka,OPD Room
no-16, kadamkuan
Patna Bihar 800003
BIHAR Patna
Patna
BIHAR |
9608062920
drjagriti2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L449||Papulosquamous disorder, unspecified. Ayurveda Condition: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: VIPADIKAHAR GHRIT TAIL, Reference: charak chikitsasthan chapter 7/120-121, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dushivishari Agad, Reference: sushrut kalpa sthan 2/51, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
presence of dushi/gara visha as an etiology by questionnaire |
|
| ExclusionCriteria |
| Details |
less than 12 yrs and more than 70 yrs patient having known severe disease like AIDS,Cancer,Diabetes,TB, Severe heart disease, Jaundice, Renal failure, anxiety disorders & others |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess improvement in Sign and Symptoms of Vipadika kustha (palmoplantar psoriasis), i.e., relief in itching, roughness of affected site, pain and burning sensation at the affected site |
90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the Effectiveness of Vipadikahar Ghrit Tail in Itching, Roughness, Pain, & Cracking
2. To assess the Effectiveness of Dushivishari Agad in Itching, Roughness, Pain, & Cracking
3. To compare the Effectiveness of Vipadikahar Ghrit Tail & Dushivishari Agad in Itching, Roughness, Pain, & Cracking |
90 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 |
|
Date of First Enrollment (India)
|
26/05/2025 |
| 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)
|
Not Applicable |
| 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
|
Vipadika is a type of gudra Kuasha described in Chanak Samhita. Palmo-plantar psoriasis is one such disease that can’t be correlated exactly with any disease mentioned in Ayurveda, but to a certain extent, based on its symptoms, it can be correlated with Vipadiko. It involves predominantly Vota and Kapha dosho and is characterized by Pani Pada Sphutan (fissure in palm and soles) and severe pain (Teevra Vedang). Kustha Vipadikahara Ghrit Taila is a herbal mineral topical formulation used in traditional Ayurvedic medicine for skin conditions, which is mentioned in Charak Samhita. Dushivisha may be one of the causes of Vipadika Kustha. Dushivishari Agad (DVA) indicated in Dushivisha. So, it is also used for treatment of Vipadika Kustha. Vipadika Kustha (palmo-plantar psoriasis) poses a particularly difficult medical problem due to its chronic relapsing gature. The drug used in this trial is Vipadikahara Ghrit Tail, and Dushivishari Agad mentions it in Ayurveda text with the hope that it will prove more efficacious, less toxic, and easy to use. This drug is easily available, chief, and effective in Vipadika. Duration of treatment is 45 days. Patient will be taken from OPD of Government Ayurvedic College and Hospital. |