Malaria Clinical Trial
Official title:
A Pilot Study of the Use of Homeopathic-Based Treatment Approaches to Reduce the Prevalence of Malaria in Depressed Communities
Verified date | February 2009 |
Source | Malamed |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sierra Leone: Ministry of Health and Sanitation |
Study type | Interventional |
Malaria accounts for over 40% of outpatient morbidity in Sierra Leone. These health risks have been heightened further by the recent civil war, persistent poverty, lack of access to affordable health care, and an increasing resistance of P.falciparum parasites to the most commonly used therapy Chloroquine, which now has a confirmed failure rate of 39%. This study will recruit 780 people from the Kroo-Bay community in Freetown. Healthy subjects would be randomised into two subgroups and given either homeopathic pellets or placebo tablets at four month intervals. They are then monitored repeatedly during the study period to assess the efficacy of the therapy in reducing the disease burden.
Status | Completed |
Enrollment | 731 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Willingness to participate: - Ability to understand and sign consent form, - Permanent residence within 10km radius of Kroo Bay Exclusion Criteria: - Serious Underlying Illness, - Absence from the study for 4 months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Sierra Leone | Malamed | Freetown |
Lead Sponsor | Collaborator |
---|---|
Malamed | Blackie Foundation Trust |
Sierra Leone,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | reduction in the burden and severity of malaria episodes | four months | No |
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