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Clinical Trials/CTRI/2018/11/016336
CTRI/2018/11/016336
Not Yet Recruiting
Phase 4

A community-based, randomized, controlled study to evaluate the efficacy of topical mosquito repellent BMB essential oil for the control of Malaria

Gods Own Store LLP0 sites0 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Gods Own Store LLP
Status
Not Yet Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Gods Own Store LLP

Eligibility Criteria

Inclusion Criteria

  • •1\.Communities consisting of multiple households, living in proximity of each other will be chosen.
  • •2\.The communities should have similar environment and mosquito prevalence.
  • •3\.The communities should be accessible for the survey.
  • •4\.Participants should be willing to sign a written consent for participation in the study.
  • •5\.Participants must be willing to commit to use of intervention and assessment visits for evaluation.
  • •6\.Participants must be willing to refrain from using any other means for protection from mosquitoes, such as mosquito repellent devices, cream, sprays etc, from the outset of the study until final evaluation (if patient force to take above said medicine, subject will be dropped from the study).
  • •7\.Participants must agree to maintain hygienic life style.

Exclusion Criteria

  • •1\.Communities that are distant from each other or inaccessible.
  • •2\.Communities with dissimilar living environments and mosquito prevalence.
  • •3\.Children under the age of one year.
  • •4\.Participants with history of malaria, dengue or chikangunya in past 6 months.
  • •5\.Participants with evidence or history of significant systemic, immunological, gastro\-enteric or gastrointestinal disorder (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
  • •6\.Any participant who is not able to give adequate informed consent.
  • •7\.Patients reporting use of prescription or non\-prescription drugs that has not been pre\-approved by the study physician.
  • •8\.Participant with known allergies to the main components of the test or comparator product.
  • •9\.Participation in another clinical trial or taking an investigational product in the past three months

Outcomes

Primary Outcomes

Not specified

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