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Clinical Trials/CTRI/2023/05/052676
CTRI/2023/05/052676CompletedNot Applicable

A Randomized open labelled controlled clinical study to evaulate the efficacy of Dadrughna Lepa in the management of Dadu Kushta with special reference to Fungal Dermatophytosis.

Dr VISHNU S1 site in 1 country30 target enrollmentStarted: January 6, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Changes in KASI score

Study Overview

Brief Summary

Skin is the largest organ of the human body. Its size and external location make it susceptible to a wide variety of disorders.In recent years, there has been a considerable increase in the incidence of skin conditions in the tropical and developing countries like india.Skin disorders are known to be the fourth most common causes of all human diseases affecting nearly 1/3rd of population in the world.All the skin diseases are explained under the heading of Kushta in Ayurveda. Dadru Kushta is one of the commonly occurring skin disease and is KaphaPitta predominant.ED-4.3.6 specific code that can be used to indicate the Dadru Kushta as mentioned in NAMASTE PORTAL (National Ayush Morbidity and standardised terminologies electrical portal).The symptoms like Durvavat deerghapradhana indicates its spreading nature, Athasi indicates its coppery red colour, Kandu(itching) and Anushangini its chronic nature.Most of the features of Dadru Kushta is similar to the features of dermatophytosis.Dermatophytosis is the fungal infection of the skin.It can be developed from 40 types of fungi, of which dermatophytes trichophyton,microsporum and epidermophyton are the common causative agents.B5.9 is a specific ICD-10-CM code to indicate the diagnosis of Dermatophytosis.The typical clinical presentation of this disease is red, itchy and scaly circular lesion.Globally,up to 20% of the human population may be infected by dermatophyte at a time. The last few years shows a significant rise in the incidence of chronic Dermatophyte infections of skin,which have been proven difficult to treat.In contemporrary medical science, management of Dermatophytosis is carried out with Topical fungicidal agents like natamycin, clotrimazole, econazoles, miconazoles etc and systemic anti-fungal agents like Griseofulvin, Ketocenazole are advocated. Systemic fungicidal are highly toxic.Topical fungicidal require prolonged application and recurrence poses a problem in addition to appearance of resistance and long lasting usage produce the adverse effect like flaking of skin, irritation, redness etc.Hence,there is a need to contribute with safe and cost effective remedy in management of Dadru Kushta to effectively manage the disesase and not to cause any ill effects on body.In Ayurveda,many effective formulations without side effects are available. A series of studies conducted in recent past comprising of  topical applications have showed mild to moderate response in Dadru Kushta. Here arises the importance of unique formulation in the management of Dadru Kushta.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Open Label

Eligibility Criteria

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

Inclusion Criteria

  • SUBJECTS FALLING UNDER B36 OF ICD10 CLASSIFICATION,CLINICAL SIGNS AND SYMPTOMS OF DADRU KUSHTA AS DESCRIBED IN CLASSICAL TEXTS (PRESENCE OF UDGATA MANDALA WITH OR WITHOUT OTHER SYMPTOMS),SUBJECTS WILLING TO PARTICIPATE IN THE STUDY WITH WRITTEN INFORMED CONSENT WHICH IS CONVEYED IN THE LANGUAGE WHICH THE SUBJECT CAN UNDERSTAND.

Exclusion Criteria

  • PREGNANT AND LACTATING WOMEN.
  • SUBJECTS HAVING ANY UNCONTROLLED SYSTEMIC ILLNESS WHICH CAN INTERFERE WITH THE COURSE OF DISESASE AND TREATMENT, OTHER OVERLAPPING DERMATOLOGICAL DISEASES WILL BE EXCLUDED, SUBJECTS UNDER ANTI-FUNGAL DRUGS WILL BE EXCLUDED.

Outcomes

Primary Outcomes

Changes in KASI score

Time Frame: before intervention-0th day | during intervention-10th day | after intervention-21st day | follow up-28th day

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr VISHNU S
Sponsor Class
Other [self]

Study Sites (1)

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