A randomized, double-blind, placebo-controlled, study to assess the immunomodulatory effect of the Gingeride in adults; A pilot study with an open label cross-over extension.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1. Change from baseline value of Th1 (interferon-γ) and Th2 (interleukin-4) between groups.
研究概览
简要总结
This is a randomized, double-blind,placebo-controlled study to assess the Immunomodulatory effect and safety ofthe Gingeride in adults. The study will also have an open label cross-overextension. Study will be conducted in male and female participants between theages of 18-35 years (inclusive of both the ages). Screening data will bereviewed to determine participant’s eligibility. Participants who meet allinclusion criteria and exclusion criteria will be enrolled in the clinicalstudy.
A total of 24 participants will be enrolledin the clinical study and randomized into either of the 2 groups in the ratioof 1:1 (Group A: Gingeride) for 60 days and Group B: Placebo for 30 daysfollowed by 30 days of administration of standardized Gingeride.
Each enrolled participants will receive theirrespective IP, as per the randomisation, from baseline till day 30. On day 30,(±2 days) (Visit 3), unblinding procedure will be performed. Participantsreceiving Gingeride for the first 30 days will continue to receive the same forthe next 30 days while participants receiving the placebo will be receivingGingeride for the next 30 days of the study.
The treatment duration is approximately 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female participants aged 18-35 years (inclusive of both the ages) with a BMI of ≤ 30 kg/m
- •2.Participants generally in good health status as confirmed by investigator based on clinical history, physical exam, and routine blood analysis.
- •3.The participant must not have taken any vitamin/mineral/dietary or herbal supplements, 1 month prior to enrollment in the study.
- •4.Participant must be able & willing to comply with study procedures.
- •5.Participant willing to sign the informed consent.
排除标准
- •1.History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
- •2.Diagnostic history of any allergies.
- •3.Intention to use any vitamins and/or minerals and/or dietary and/or herbal supplements during the study period.
- •4.Participants with the diagnostic history of cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease
- •Participants who had undergone any surgery during last one year.
- •6.With the history or planning organ transplantation.
- •7.Smokers and alcohol/drug abuse 8.Pregnant& lactating women.
- •9.Participant taking any other investigation drug and currently being a part of any other clinical trial/research.
- •10.Women of childbearing potential who are not willing to follow a reliable and effective contraceptive measure during the study.
- •11.Any other underlying conditions which might affect immunity and/or the evaluation of the response of the study medication.
结局指标
主要结局
1. Change from baseline value of Th1 (interferon-γ) and Th2 (interleukin-4) between groups.
时间窗: 1. Day 1 (Baseline), Day 30, and Day 60 | 2. Day 1 (Baseline), Day 30, and Day 60 | 3. Day 1 (Baseline), Day 30, and Day 60
2. Change from baseline values of Immunoglobulin (IgG, IgM, and IgA) levels between groups
时间窗: 1. Day 1 (Baseline), Day 30, and Day 60 | 2. Day 1 (Baseline), Day 30, and Day 60 | 3. Day 1 (Baseline), Day 30, and Day 60
3. Change from baseline in Pittsburgh Sleep Quality Index (PSQI)
时间窗: 1. Day 1 (Baseline), Day 30, and Day 60 | 2. Day 1 (Baseline), Day 30, and Day 60 | 3. Day 1 (Baseline), Day 30, and Day 60
次要结局
- 1. Hematology and Biochemistry(2. Occurrence of any AE or SAE)
- To evaluate the efficacy among the active group for the extended treatment duration in terms of change in Th1 (interferon-γ), Th2 (interleukin-4), Immunoglobulin (IgG, IgM, and IgA) and sleep quality index(Day 1 (Baseline), Day 30 and Day 60)