Actively Recruiting

Phase Not Applicable
Age: 5Years - 60Years
All Genders
ID06819449

Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients and Its Relation to Multi-Drug Therapy: Randomized Clinical Trial

Led by South Valley University · Updated on 2025-02-11

50

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Mycobacterium leprae is a slow-growing bacterium that causes leprosy, which can take two to ten years to develop after infection. The bacteria mainly affect peripheral nerves, potentially causing tissue damage, painless burns, ulcers, and loss of protective sensation. This trial examines the role of Rab 32 gene polymorphisms as a possible prognostic factor in leprosy patients while evaluating the effects of standard multi-drug therapy. Participants with leprosy will receive a combination of dapsone, clofazimine, and rifampicin as per World Health Organization guidelines. About 40 patients will be treated with this multi-drug therapy, and blood samples will be collected after three months to study the Rab 32 gene's role. Additionally, around 10 healthy individuals will provide blood samples for comparison, with no treatments administered to them. During the study, participants will undergo assessments including venous blood collection to analyze the Rab 32 gene and monitor treatment impact. Researchers will evaluate treatment outcomes over six months, tracking the effectiveness of the multi-drug therapy. This study aims to better understand genetic factors affecting leprosy prognosis and treatment responses, with safety monitored throughout the trial period.

CONDITIONS

Brief Title

Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients

Who Can Participate

Age: 5Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of both sexes with positive slit skin smear for Mycobacterium leprae
  • Aged between 5 and 60 years
Not Eligible

You will not qualify if you...

  • Contraindications to multi-drug therapy
  • Hypersensitivity to sulfa drugs
  • Hypersensitivity to clofazimine or rifampicin
  • Pregnant or lactating women

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants with leprosy receive multi-drug therapy consisting of dapsone, clofazimine, and rifampicin to treat their condition.

Regular visits as part of outpatient treatment

Trial Site Locations

Total: 1 location

1

Qina University hospital, South Valley University Hospital

Qina, Egypt

Actively Recruiting

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Research Team

L

Lydia Atef Nassief, MSc

E

Eisa Mohammed Hegazy, Assist. Prof

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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