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MalariaPhase 4NCT00351013

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

A Phase 4 study testing Malaria Tropica Nosode D200 in people with Malaria, run by Malamed at 1 site in Sierra Leone.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
Malaria Tropica Nosode D200
Could I receive a placebo?
No, everyone receives an active treatment
How many people
731 participants
Where
1 siteSierra Leone
Study dates
Jun 2006to Jun 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sierra Leone1 site
  • Malamed

    Freetown

Other trials in Sierra Leone

About this study

Official title: A Pilot Study of the Use of Homeopathic-Based Treatment Approaches to Reduce the Prevalence of Malaria in Depressed Communities

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.

Read the 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.

Conditions
Malaria
Being tested
Malaria Tropica Nosode D200
Keywords
malaria, Plasmodium falciparum, Tropica Nosode, Homeopathy
Medical subject headings
Malaria, Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Malaria Tropica Nosode D200Other

    5 pellets every four months

Study groups in NCT00351013
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Other: Malaria Tropica Nosode D200

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. reduction in the burden and severity of malaria episodes

    Measured: four months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionJun 2007
  4. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
731 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00351013
Sponsor's protocol ID
BFT2006/2
Status last verified
Feb 2009
First submitted
11 Jul 2006
Last updated
4 Feb 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Malaria Tropica Nosode D200 in people with Malaria, run by Malamed at 1 site in Sierra Leone.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

reduction in the burden and severity of malaria episodes (time frame: four months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.

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