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Development of Topical Herbal Formulations for Treatment of Cutaneous Leishmaniasis

NCT04841239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-04-12

No results posted yet for this study

Summary

Infections due to protozoa of the genus Leishmania are a major worldwide skin problem, with high endemicity in developing countries including Pakistan. As far as concern for the treatment of cutaneous leishmaniasis (CL), there is no single therapeutic agent that has proved a satisfactory efficacy and safety. Therefore, the objective of this research study was to develop an alternative therapeutic approach for the treatment of CL. In the current research protocol, two herbal topical formulations (Gyburene and Thuscare) were prepared containing to contain 5% Casuarina equisetifolia L. and Thespesia populnea L. plant extract and evaluate their leishmanicidal potential in pre-clinical and randomized clinical trials studies. Preclinical studies were performed on BALB/c mice after the development of a lesion on the dermis caused by the Leishmania (L.) major parasite. Six weeks randomized, single single-blind placebo controlled study was also conducted on seventy eight L. major infected patients divided into three groups i.e. treated, reference and placebo with the 1:1 ratios.

Conditions

  • Leishmaniasis, Cutaneous

Interventions

OTHER

Herbal topical formulation

Sponsors & Collaborators

  • Jinnah Sindh Medical University

    lead OTHER

Principal Investigators

  • Yousra Shafiq, Ph.D · Jinnah Sindh Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2014-12-30
Completion
2014-12-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841239 on ClinicalTrials.gov