A community-based, randomized, controlled study to evaluate the efficacy of topical mosquito repellent BMB essential oil for the control of Malaria
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- 1.Decrease in incidence of mosquito bites, both inside and outside household and
研究概览
简要总结
Eligible households from the selected communities screened in baseline interview will be randomized into three groups to use either the test product BMB or the comparator, mosquito net or both (BMB and net) to repel mosquitoes in their daily lives. The baseline interview with individual household head will collect demographic data of the entire household, presently used mosquito repellent, presence of adequate number of undamaged mosquito nets etc. Households will also be asked questions pertaining their past medical history, especially occurrence of mosquito transmitted diseases such as malaria and dengue.
Subjects will be evaluated at the end of every three months (assessment surveys) for upto 6 months, Participants will be inquired about any changes in incidences of mosquito bites, as experienced, after application of test product. In case subjects report fever with chills a blood samples will be collected to test for malaria parasite during follow-up surveys to test for incidence of malaria. The primary outcome of the study is detection of malaria parasites (P. falciparum and/or P. vivax) through examination of microscopic blood slides collected from finger-pricks. Safety analyses will be done at each visit. Any allergy or other adverse reactions to the test product will also be recorded. Participants’ opinion about the aesthetic nature of the test product will also be noted in Diary card.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1.Decrease in incidence of mosquito bites, both inside and outside household and
时间窗: Day 0 | Day 90 | Day 180
. Criteria for efficacy are:
时间窗: Day 0 | Day 90 | Day 180
2.Decrease in incidences of malaria transmitted by mosquitoes.
时间窗: Day 0 | Day 90 | Day 180
次要结局
- The secondary endpoints comprise of the safety analyses i.e. adverse event including SAEs(Day 0)