Leishmaniasis, Cutaneous Clinical Trial
Official title:
Development of Topical Herbal Formulations for Treatment of Cutaneous Leishmaniasis: A Single Blind, Randomized, Placebo Controlled Preclinical and Clinical Trials
Verified date | April 2021 |
Source | Jinnah Sindh Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | December 30, 2014 |
Est. primary completion date | December 30, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years and older |
Eligibility | Inclusion Criteria: - The inclusion criteria for participants including; - • 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Civil Hospital | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Jinnah Sindh Medical University |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Measurement of lesions size between placebo, treated and reference groups after the six weeks treatment period | For the monitoring of healing progressed, photographs were taken before, during and after completion of therapy using a digital camera while healed area was calculated by percentage of healing by following formula:
Healed area percent of wound contraction = ………………………………. ×100 Total area before treatment |
6 weeks |
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