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Clinical Trials/CTRI/2019/06/019781
CTRI/2019/06/019781Not yet recruitingPhase 2

Long Term Efficacy evaluation of Irsal-i-Alaq (Leech Therapy) in Qooba (Dermatophytosis)- A Randomised Standard Controlled Open Clinical Study.

National Institute of Unani Medicine1 site in 1 country40 target enrollmentStarted: June 24, 2019Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
40
Locations
1
Primary Endpoint
Photographs of the affected site in a fixed location and controlled illumination.

Study Overview

Brief Summary

Dermatophytosisrefers tosuperficial fungal infection of keratinized tissues caused by keratinophilicdermatophytes. According to observations worldwide, dermatophytosis isthe most common superficial fungal infections. It is common in tropics and may presentin epidemic proportions in areas with high rates of humidity.

In Unani system of medicine, a disease mentionedwith name of Qooba, is characterized by roughness of thesurface of the skin associated with itching, scaling, dryness, and shedding ofscales like fish.Itmay be black or red in colour, usually periphery is red and occasionally theremay be oozing of yellowish fluid. Allthese conditions develop according to pathogenic substances, as per Unaniphilosophy. Dermatophytosisis given name according to the sites involved Tinea capitis, Tinea corporis,Tinea faciei,Tinea manuum, Tinea pedis, Tinea ungum, Tinea cruris,Tinea incognito. Treatmentof dermatophytosisis often dependent on the clinical setting ideally, mycological confirmation ofthe clinical diagnosis should be gained before systemic antifungal treatment iscommenced. Oraltreatment options for dermatophytosisare Itraconazole,Fluconazole, Terbinafine,and Griseofulvin.

InUnanisystem of medicine there are number of treatments for Qooba,in which Irsal-i-Alaq(Leeching) is one of the best treatment described by the Unaniphysicians. Irsal-i-Alaqis used to evacuate the pathological humour from the body to treat the variousailments. Accordingto Ahmad bin Muhammad TabriIrsal-i-Alaqover affected site will eliminate the disease completely. Inspiredby all these facts, this study was design to evaluate not only the efficacy butlong-term effects of Irsal-i-Alaq inQooba, comparing withstandard antifungal treatment for the same.

Study Design

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

Eligibility Criteria

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

Inclusion Criteria

  • •Clinically Diagnosed patient of Qooba (Tinea corporis and Tinea pedis only, as leech application will be more feasible to these sites) Willing to participate in the study and follow the instructions.

Exclusion Criteria

  • •Uncontrolled Diabetes mellitus Bleeding disorder & anaemia Acute infection & septicaemia Patients on concomitant therapy Immuno-compromised patients.

Outcomes

Primary Outcomes

Photographs of the affected site in a fixed location and controlled illumination.

Time Frame: At Baseline, on 21st day and on 35th day. | Follow ups on 35th day in person and over phone on 45th, 60th and 90th day.

KOH smear

Time Frame: At Baseline, on 21st day and on 35th day. | Follow ups on 35th day in person and over phone on 45th, 60th and 90th day.

Erythema and Scaling will be graded on a 4 point scale (0 Absent, 1 Mild, 2 Moderate and 3 Severe)

Time Frame: At Baseline, on 21st day and on 35th day. | Follow ups on 35th day in person and over phone on 45th, 60th and 90th day.

Pruritus will be assessed on 10 cm long Visual Analogue Scale (VAS).

Time Frame: At Baseline, on 21st day and on 35th day. | Follow ups on 35th day in person and over phone on 45th, 60th and 90th day.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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