NCT00351013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
731

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

July 11, 2006

Last Update Submit

February 3, 2009

Conditions

Malaria

Keywords

malariaPlasmodium falciparumTropica NosodeHomeopathy

Outcome Measures

Primary Outcomes (1)

  • reduction in the burden and severity of malaria episodes

    four months

Study Arms (1)

1

EXPERIMENTAL
Other: Malaria Tropica Nosode D200

Interventions

Malaria Tropica Nosode D200OTHER

5 pellets every four months

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness to participate:
  • Ability to understand and sign consent form,
  • Permanent residence within 10km radius of Kroo Bay

You may not qualify if:

  • Serious Underlying Illness,
  • Absence from the study for 4 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malamed

Freetown, Sierra Leone

Location

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Jacob Minah, MD

    Specialist Pediatrician, Homeopath, Germany

    PRINCIPAL INVESTIGATOR

  • Florence M. Margai, PhD

    Professor, Binghamton University-New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 12, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

SI(1)