Efficacy of Leech therapy in Ringworm

Phase 2

Not yet recruiting

Conditions: Dermatophytosis, unspecified,

Registration Number: CTRI/2019/06/019781

Lead Sponsor: National Institute of Unani Medicine

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KOH smear	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)	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).	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.
Photographs of the affected site in a fixed location and controlled illumination.	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 Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): National Institute of Unani Medicine
🇮🇳
Bangalore, KARNATAKA, India
National Institute of Unani Medicine
🇮🇳Bangalore, KARNATAKA, India
Jamil Ahmad
Principal investigator
9412108238
jamilji2k11@gmail.com