CTRI/2023/04/051394招募中3 期
A Multicentric, Randomized, Double Blind, Parallel Group, Two Arm, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Manda Koso versus Placebo in patients with immune deficiency.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- Mean change in CD4, CD8 count, CD4:CD8 ratio from baseline to end of the study visit.
研究概览
简要总结
A Multicentric, Randomized, Double Blind, Parallel Group, Two Arm, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety and TolerabilityofManda Koso versus Placebo in patients with immune deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
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.Male or female patients aged between 18 and 65 years (both inclusive). 2.Subjects with CD4 count 300 to 700 cells per cubic millimeter. 3.Subjects with (Immune Status Questionnaire) ISQ Score is ≤
- •4.Subjects with Non-alcoholic grade -I Cirrhosis OR Latent TB OR Hypothyroidism OR HIV will be included in the study. OR Subjects with history of Non-alcoholic grade.
- •I Cirrhosis OR Controlled Type 2 DM OR Latent TB OR Hypothyroidism OR HIV for at least 2 months will be included. 5.Written, signed and dated informed consent obtained from patients before performing any study related procedures. 6.Subjects willing to comply with the protocol requirements.
排除标准
- •1.Subjects having history of hypersensitivity to any of components of the formulation.
- •2.Subjects having history of allergy to any of soy, sesame and walnut or other components of the formulation.
- •3.Subjects with history of uncontrolled diabetes mellitus, unstable angina pectoris, and myocardial infarction (MI).
- •4.Subjects with HbA1c ≥ 8%.
- •5.Subjects with AIDS.
- •6.Subjects taking steroid treatment.
- •7.Subjects with terminal illness.
- •8.Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- •9.Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study.
- •10.Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.
结局指标
主要结局
Mean change in CD4, CD8 count, CD4:CD8 ratio from baseline to end of the study visit.
时间窗: Mean change in CD4, CD8 count, CD4:CD8 ratio from week 1 to week 13.
次要结局
- 1.Mean change in interferons gamma from baseline to end of the study visit.(2.Mean change in Interleukins-12 from baseline to end of the study visit.)
研究者
研究点 (3)
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