CTRI Number |
CTRI/2023/05/052913 [Registered on: 19/05/2023] Trial Registered Prospectively |
Last Modified On: |
18/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Other (Specify) |
Study Design |
Single Arm Study |
Public Title of Study
|
Effectiveness of drug Dhaturadi Tail on patients affected on Vipadika local |
Scientific Title of Study
|
An Experimental Dermal Safety Study of Dhaturadi Tail in Rats and it’s Clinical Efficacy in Vipadika Through Local Application |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Suman Chandra |
Designation |
P.G.Scholar |
Affiliation |
Shri N.P.A.Government Ayurveda College Raipur Chhattisgarh |
Address |
Department of Agadtantra Evum Vidhi Ayurveda 1st floor ,Shri N.P.A. Government Ayurveda college. G.E.Road Raipur Chhattisgarh Shri Khudada Dungaji Government Ayurveda Hospital G.E.Road Raipur Chattisgarh Raipur CHHATTISGARH 492010 India |
Phone |
9753318989 |
Fax |
|
Email |
sc17101994@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrSRInchulkar |
Designation |
Prof.and HOD Agadtantra Evum Vidhi Ayurveda Department |
Affiliation |
Shri N.P.A.Government Ayurveda College Raipur Chhattisgarh |
Address |
Department of Agadtantra Evum Vidhi Ayurveda 1st floor ,Shri N.P.A. Government Ayurveda college. G.E.Road Raipur Chhattisgarh Shri N.P.A. Government Ayurveda college. G.E.Road Raipur Chhattisgarh Raipur CHHATTISGARH 492010 India |
Phone |
9425215318 |
Fax |
|
Email |
sinchulkar@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr SRInchulkar |
Designation |
Prof.and HOD Agadtantra Evum Vidhi Ayurveda Department |
Affiliation |
Shri N.P.A.Government Ayurveda College Raipur Chhattisgarh |
Address |
Department of Agadtantra Evum Vidhi Ayurveda 1st floor Shri N.P.A. Government Ayurveda college. G.E.Road Raipur Chhattisgarh Shri N.P.A. Government Ayurveda college. G.E.Road Raipur Chhattisgarh Raipur CHHATTISGARH 492010 India |
Phone |
9425215318 |
Fax |
|
Email |
sinchulkar@yahoo.co.in |
|
Source of Monetary or Material Support
|
ShriN.P.A.government Ayurveda College Raipur Chattisgarh 492010 |
|
Primary Sponsor
|
Name |
Shri n.p.a.Government Ayurveda college Raipur C.G. India |
Address |
Shri n.p.a.Government Ayurveda college Raipur C.G. G.E. Shri n.p.a.Government Ayurveda college Raipur C.G. India Road Raipur Chhattisgarh 492010 |
Type of Sponsor |
Government medical college |
|
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 Suman chandra |
Shri NPA government Ayurveda college, Raipur |
Department of Kayachikitsa OPD 2 shri khudad Dungaji goverment ayurveda Hospital raipur Chattisgarh Raipur CHHATTISGARH |
9753318989
sc17101994@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethical committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, (2) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VIPADIKA, (3) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VIPADIKA, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: dhaturadi tail, Reference: Yogaratnakar, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Nil |
|
Intervention |
Dhaturadi Tail |
Composition of Dhaturadi Tail-1.Dhatura beej 2.Mankand 3. Katu Tail. It cures vipadika.
Duration-30 days. |
Comparator Agent |
Nil |
Nil
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Diagnosed patients with clinical features of Vipadika according to Ayurveda and modern |
|
ExclusionCriteria |
Details |
Patients below 18 yr age and above 60 yr age, Having chronic skin manifestation like SLE. Patients having complaints for more than 5 yr. |
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Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Reduction of symptoms of Vipadika
Pain-pada sphutana, Vedana |
First follow up after 7days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction in symptoms - raga toda Kandu |
30 days |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
01/06/2023 |
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="5" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Avurveda is the traditional, ancient Indian system of health science. Ayurveda is a science of life and aim of the Ayurveda is to maintain the health of the healthy person and cure the diseases. All skin diseases in the Ayurveda have been considered under the heading of Kustha. VIPADIKA in one of such diseases which have been included under the heading of Kshudra-kustha. Vipadika skin disease is included in Kshudra-kushtha with Vata-Kaphadosha involvement and it is characterized by Pani-Pada Sphutana (fissure in palm and soles) andTivravedana’ (severe pain) Vipadika is correlated with palmer planter psoriasis which is a chronic skin disease which mainly affects the palms and sole region. Especially in palmer-planter psoriasis painful fissures and bleeding is more common. In chalking out a practical line of treatment, we need to understand that in between the hectic schedule of today’s life, there is a need of simple and effective remedy in order to regain the texture of hand and foot cosmetically and gain relief from the symptoms, external applicationhave excellent results. Acharya Yogratnakar has mentioned Dhaturadi Tail in themanagement of Vipadika consisting three drug which are having properties of snehana, ropan, kandughna, shothahar, kusthaghna and other properties. The main constituent of the Dhaturadi Tail is "Dhatura Beej" Keeping all these points, Dhaturadi Tail is planned, to evaluate for its toxicity in wistar albino rats for the safety purposes & if no toxicity is found in pre clinical experimental studies then its clinical efficacy will be observed in Vipadika.
NEED OF STUDY- Skin is the largest organ of the body which first exposed with the environment agents likephysical chemical and biological agent. Skin plays chief role in maintaining barrier betweeninternal and external environment of human body. The healthy skin is the primary requirement for the beauty as well as attractive personality. Vipadika is one of such disease which has been included under the heading of Kshudra- kustha. Main symptoms of Vipadika are cracks (sphutana) either in palms or soles or in both with severe pain. The pain present of Vipadika is so intense that it severely afflicts the qualityof life of the patients. In spite it being a minor condition it stultifies the routine work of patients, they make the patient worried due to its external appearance. And severe itching or burning or oozing disturbs his/her day to day life. It also gives mental agony as a cosmetic problem. In chalking out a practical line of treatment, we need to understand that in between the hectic schedule of today’s life, there is a need of simple and effective remedy in order to regain the texture of hand and foot cosmetically and gain relief from the symptoms external application have excellent results. By considering this fact, Dhaturadi tail may be better choice for the treatment of Vipadika by its snehana, ropan, vedanahar, shothahar, kusthaghna, kandughna and others properties. Hence the present study, Dhaturadi tail isselected for VIPADIKA. It comprises as an ingredient Datura Beej, it has poisonous. property. There may be a possibility of having toxic effects to the people. Hence it feelsnecessary to plan the dermal toxicity of this oil. Therefor, toxicity of Dhaturadi tail will be evaluated in wistar albino rats for the safety purposes, If no toxicity will be observed then further clinical efficacy of the Dhaturadi Tail on Vipadika will be studied but if any toxicity occurs then the study will be stopped.
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