Evaluation of efficacy and safety of deworming property of Aptivate Syrup in children suffering from Helminth Infections /helminthiasis- An open label, non-comparative, prospective, clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
It is an evaluation of efficacy and safety of deworming property of Aptivate Syrup in children suffering from Helminth Infections helminthiasis- An open label, non-comparative, prospective, clinical study. The study will be carried out at 1 to 2 centres in India. Subjects of age group 3 to 6 years will be instructed to take Aptivate syrup in a dose of 2.5 mL twice daily for 30 days and subjects of age 7 to14 years will be instructed to take Aptivate syrup in a dose of 5 mL twice daily for 30 days. Primary objective of the study will be to assess percent reduction in fecal egg count (ova and cyst counts of various helminths). The secondary objectives of the study will be to assess parasitological cure rate, change in clinical symptoms i.e. abdominal pain, diarrhea, abdominal fullness, flatulence, over all digestion, Sleep, satiety, fatigue, general energy levels and physical activity, change in weight, safety and tolerability through adverse event (AE) reporting, vital and clinical signs and symptoms on screening (Days up to 5), Baseline visit (Day 0), Follow up visit 1 (Day 15) and End of study visit (Day 30)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants must be an otherwise healthy child, based on medical history, physical examination, vital signs and concomitant medications
- •Participants with presence of intestinal helminths eggs in the stool
- •Participant must be available to return to the study site for all visits, including the follow-up visit
- •Parent(s) or guardians of participants (or their legally-accepted representatives) must be willing to sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study
- •Children 6 years of age and older will be asked to assent (agree) to their participation using appropriate language to their level of understanding; assent will be documented.
排除标准
- •Participant has active diarrhea (defined as the passage of 3 or more loose or liquid stools per day) at screening or at the time of randomization
- •Participant has a significant medical disorder, participant has difficulty in chewing or swallowing
- •Participant has clinically significant signs and symptoms of anaemia
- •Participant has significant wasting (greater than 2 standard deviations below the mean World Health Organization Child Growth Standards for weight-for-height or body mass index)
- •Participant has a known hypersensitivity to any ingredients of investigational product
- •Participant has preplanned surgery or procedures that would interfere with the conduct of the study during the course of study
- •Participant has taken any form of deworming medication within 30 days of entry into the study.
- •Any other condition due to which children are deemed to be unsuitable by investigator for reason(s) not specifically stated in the exclusion criteria.
研究者
Dr Narendra Mundhe
KVTR Ayurvedic College and Hospital, Boradi