Herbal Oil application in the prevention of Mosquito bite

Phase 4

Registration Number: CTRI/2018/11/016336

Lead Sponsor: Gods Own Store LLP

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
. Criteria for efficacy are: <br/ ><br>1.Decrease in incidence of mosquito bites, both inside and outside household and <br/ ><br>2.Decrease in incidences of malaria transmitted by mosquitoes. <br/ ><br>Timepoint: Day 0 <br/ ><br>Day 90 <br/ ><br>Day 180

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints comprise of the safety analyses i.e. adverse event including SAEsTimepoint: Day 0 <br/ ><br>Day 90 <br/ ><br>Day 180 <br/ ><br>