The Use of Homeopathic-Based Treatment Approaches to Reduce the Prevalence of Malaria in Depressed Communities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00351013
Recruitment Status : Completed
First Posted : July 12, 2006
Last Update Posted : February 4, 2009
Blackie Foundation Trust
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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.

Condition or disease Intervention/treatment Phase
Malaria Other: Malaria Tropica Nosode D200 Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 731 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Pilot Study of the Use of Homeopathic-Based Treatment Approaches to Reduce the Prevalence of Malaria in Depressed Communities
Study Start Date : June 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: 1 Other: Malaria Tropica Nosode D200
5 pellets every four months

Primary Outcome Measures :
  1. reduction in the burden and severity of malaria episodes [ Time Frame: four months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00351013

Sierra Leone
Freetown, Sierra Leone
Sponsors and Collaborators
Blackie Foundation Trust
Principal Investigator: Jacob Minah, MD Specialist Pediatrician, Homeopath, Germany
Principal Investigator: Florence M. Margai, PhD Professor, Binghamton University-New York

Responsible Party: Dr. Jacob Minah, Malamed Identifier: NCT00351013     History of Changes
Other Study ID Numbers: BFT2006/2
First Posted: July 12, 2006    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by Malamed:
Plasmodium falciparum
Tropica Nosode

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases