The Use of Homeopathic-Based Treatment Approaches to Reduce the Prevalence of Malaria in Depressed Communities
Primary Purpose
Malaria
Status
Completed
Phase
Phase 4
Locations
Sierra Leone
Study Type
Interventional
Intervention
Malaria Tropica Nosode D200
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring malaria, Plasmodium falciparum, Tropica Nosode, Homeopathy
Eligibility Criteria
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
Sites / Locations
- Malamed
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
reduction in the burden and severity of malaria episodes
Secondary Outcome Measures
Full Information
NCT ID
NCT00351013
First Posted
July 11, 2006
Last Updated
February 3, 2009
Sponsor
Malamed
Collaborators
Blackie Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00351013
Brief Title
The Use of Homeopathic-Based Treatment Approaches to Reduce the Prevalence of Malaria in Depressed Communities
Official Title
A Pilot Study of the Use of Homeopathic-Based Treatment Approaches to Reduce the Prevalence of Malaria in Depressed Communities
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Malamed
Collaborators
Blackie Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
The main objective of this project is to evaluate the efficacy, costs and benefits of homeopathic treatment therapies.This study will be conducted in the Kroo Bay community within Freetown, the capital city of Sierra Leone. This is a region where malaria is endemic with an annual average of one malaria episode per person.Further, given the high rates of poverty, most residents cannot afford to purchase the conventional drugs used to treat the malaria. Chloroquine, which is the cheapest drug available, is no longer efficacious for P.falciparum parasites.
The study will utilize a longitudinal approach that is divided into three major phases. The first is a pre-test period involving the preparation and review of protocols, staff training, purchase of equipment and medical supplies. Phase two constitutes an open randomised controlled trial phase that is divided into five stages. The first stage IIA involves subject recruitment from the Kroo-Bay community in the capital city of Freetown. Approximately 780 permanent residents (ages 18+) living within a radius of 10 km within the community would be recruited. A questionnaire would be administered to evaluate personal case histories, use of mosquito bed nets, frequency of malaria diagnoses, the kinds of treatments used in the past, and knowledge of alternative treatment therapies. Other variables such as age, height, weight, gender, occupation and socio-economic attributes would be collected. All subjects would be tested for malaria using blood smears. Those who test positive for malaria, with clinical symptoms such as high temperature (>37.5 C) and high levels of parasitemia (asexual forms of P falciparum >5000ul blood) would be sent to the local clinic for treatment. These individuals would constitute the first subgroup in the study sample. The remaining subjects eligible for the clinical trial would be those with no major underlying illnesses, normal body temperatures and a reduced load of asexual forms of P falciparum < 5000ul blood). All subjects would be monitored for four months and asked to return for their second prophylactic treatment in four months (Day 112).
The next stage (IIB) begins after four months during which subjects are retested for malaria and based on their blood sample results (negative), healthy subjects would be given another dose of the pellets. They will be monitored for another four months. The same protocol is followed in the next three consecutive stages (IIC, IID, and IIE). During each follow-up visit, the subjects are retested and those with negative results are placed on their regimen for four months.
The clinical trial phase ends after stage IIE. In the third phase, a post-intervention survey will be given to all subjects to evaluate the levels of awareness of malaria and knowledge of alternative treatment remedies. All data measures including, residential location, blood test results, health histories and socio-demographic attributes would be compiled and analyzed statistically to evaluate the effectiveness of the homeopathic treatment. The results are expected to be published in a scientific peer-reviewed journal.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
malaria, Plasmodium falciparum, Tropica Nosode, Homeopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
731 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Malaria Tropica Nosode D200
Intervention Description
5 pellets every four months
Primary Outcome Measure Information:
Title
reduction in the burden and severity of malaria episodes
Time Frame
four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Minah, MD
Organizational Affiliation
Specialist Pediatrician, Homeopath, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Florence M. Margai, PhD
Organizational Affiliation
Professor, Binghamton University-New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malamed
City
Freetown
Country
Sierra Leone
12. IPD Sharing Statement
Learn more about this trial
The Use of Homeopathic-Based Treatment Approaches to Reduce the Prevalence of Malaria in Depressed Communities
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