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Clinical Trials/CTRI/2023/05/052913
CTRI/2023/05/052913Not yet recruitingPhase 2

An Experimental Dermal Safety Study of Dhaturadi Tail in Rats and it’s Clinical Efficacy in Vipadika Through Local Application

Shri n.p.a.Government Ayurveda college Raipur C.G. India1 site in 1 country30 target enrollmentStarted: January 6, 2023Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Reduction of symptoms of Vipadika

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Diagnosed patients with clinical features of Vipadika according to Ayurveda and modern.

Exclusion Criteria

  • Patients below 18 yr age and above 60 yr age, Having chronic skin manifestation like SLE.
  • Patients having complaints for more than 5 yr.

Outcomes

Primary Outcomes

Reduction of symptoms of Vipadika

Time Frame: First follow up after 7days

Pain-pada sphutana, Vedana

Time Frame: First follow up after 7days

Secondary Outcomes

  • Reduction in symptoms - raga toda Kandu(30 days)

Investigators

Sponsor
Shri n.p.a.Government Ayurveda college Raipur C.G. India
Sponsor Class
Government medical college

Study Sites (1)

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