Development of Topical Herbal Formulations for Treatment of Cutaneous Leishmaniasis

NCT04841239 | Completed DMC

• 1 other identifier: DISDSK-937/-22
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The lesion progression was followed microscopically and the strain presence present in biopsy material was also confirmed microscopically in both cultures and smears after six weeks treatment.

  The primary endpoint of leishmaniasis cure from topical herbal formulations was assessed microscopically in both cultures and smears.

  6 weeks

Secondary Outcomes (1)

• Measurement of lesions size between placebo, treated and reference groups after the six weeks treatment period

  6 weeks

Study Arms (2)

Herbal topical formulation

EXPERIMENTAL

Other: Herbal topical formulation

Control

NO INTERVENTION

Interventions

Herbal topical formulation OTHER

Herbal topical formulation

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who met the histological criteria for presence of parasite
• Age of older than 4 years and both gender.
• Lesions are less than 5 in number in each patient
• Size of lesion is less than 5cm2
• Participants who had stopped therapy greater than 4 weeks earlier and the lesions were not improving.
• Duration of disease for patients under trial was six months (acute) and more than one year (chronic).

You may not qualify if:

• The following patients were excluded:
• Whose clinical data were incomplete
• Participants who had received any anti anti-leishmanial or immunosuppressive drugs in the last 15 days
• Patients with co-morbid conditions, immunocompromised patients,
• Lactating mothers and pregnant women.

Sponsors & Collaborators

• Jinnah Sindh Medical University: lead

Study Sites (1)

Civil Hospital

Karachi, Sindh, 75850, Pakistan

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yousra Shafiq, Ph.D

  Jinnah Sindh Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 12, 2021
• Study Start: January 1, 2012
• Primary Completion: December 30, 2014
• Study Completion: December 30, 2014
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After study will be published
• Access Criteria: On request

Locations

PA (1)