An open labelled, multi-center, non-comparative, interventional, prospectiveclinical study to evaluate efficacy and safety of OptimaLiv Capsule in healthy participants.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in clinical characteristics/symptoms of healthy Liver functions through assessment of digestion related symptoms
研究概览
简要总结
It is an open labelled, multi-center, non-comparative, interventional,prospective, clinical study to evaluate efficacy and safety of OptimaLivCapsule in healthy participants. The study will be carried out at two centers inIndia. Subjects will be asked to take OptimaLiv in a dose of 1 capsule twicedaily orally after meals with water for 2 months. The primary objective of thestudy will be to assess changes in clinical characteristics/symptoms of healthyLiver functions through assessment of digestion related symptoms. The secondaryobjectives of the study will be to assess changes in Liver-Ultra Sonography, changesin liver functions, changes in clinical symptoms (if any), changes in clinicalsymptoms related to skin (if any), changes in energy, strength, stamina, assessmentof immunity through episodes, severity and duration of illness (infections orallergies), changes in quality of life assessed on WHO QOL BREF, changes inlipid profile levels, changes in Weight and BMI, global assessment of overallchange by investigator and subject, global assessment of tolerability of studyproduct by assessing ADRs, vitals and clinical symptoms, assessment of adverseevents and changes in pre and post product consumption safety laboratoryinvestigations on Day 0, Day 15, Day 30, Day 45 and Day 60.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy males and females with mild to moderate digestive complaints (Healthy individuals will be defined as those who are not taking any medications and do not require continuous medical care and monitoring)
- •Ready to provide written consent and follow all the study procedure.
排除标准
- •1.Subjects with known tuberculosis, hepatitis B and C, HIV, ischemic heart disease, cancer, kidney failure, chronic liver diseases, 2.Subjects having jaundice or any other symptom of active hepatitis 3.Subjects with any other investigational product within 1 month prior to randomization.
- •4.Subjects with diabetes mellitus and hypertension taking regular medications 5.Pregnant and lactating women 6.Subjects with any significant abnormal laboratory parameters 7.Known hypersensitivity to any of the ingredients of OptimaLIV Capsules 8.Other conditions, which in the opinion of the investigators, make subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study.
结局指标
主要结局
Changes in clinical characteristics/symptoms of healthy Liver functions through assessment of digestion related symptoms
时间窗: Day 0, Day 15, Day 30, Day 45 and Day 60.
次要结局
- 1.Changes in Liver-Ultra Sonography(2.Change in Liver functions)