CTRI/2024/02/062298招募中Phase 3 4
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Study to Evaluate the Effect of Gremin® on Endurance, Muscle Performance and Muscle Protection in Healthy Human Subjects.
ZeusHygia LifeSciences Private Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月11日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean change in endurance, Isometric muscle strength and fatigue
研究概览
简要总结
This is a randomized (1:1), double-blind, placebo-controlled, parallel-group clinical study. Healthy moderately active subjects meeting all inclusion and no exclusion criteria will be screened in the study. After passing the eligibility criteria, subjects will be randomized to receive Gremin®, 500 mg or placebo once a day after meals for a period of 14 days. Eligible subjects will undergo baseline assessments: endurance assessment by physical performance tests, isometric muscle strength test, and fatigue assessments. All assessments will be repeated at follow-up visit (Day 7) and end of study visit (Day 14). Blood samples will be collected for biomarker analysis and safety assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Moderate physically active (regular aerobic exercise for at least 2-3 hours per week)
- •Body Mass Index (BMI) ≤ 30 kg per m2
- •Subjects with no known musculoskeletal pathology
- •Subjects who are non-smokers
- •Female subjects of childbearing age, agree to use approved birth control methods during the study and have a negative urine pregnancy test (UPT) at screening
- •Subjects willing to adhere to their routine diet, physical activity, and general lifestyle throughout the study
- •Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •Subjects currently on or taken in the prior month any anti-inflammatory or analgesic or antioxidant drugs
- •Subjects having symptoms of viral infection
- •Subjects with history of abnormal liver or renal function tests, laboratory findings suggestive of an active inflammatory or infectious process and presence of any known disease in last 3 months.
- •Subjects with history of.
- •Uncontrolled or serious medical illness including diabetes, liver disease, hypertension.
- •Cardiac Disease or Neurological Problems.
- •Auto-immune disease (rheumatoid arthritis, lupus, type 1 diabetes).
- •Gastrointestinal tract bleeding or peptic ulcer disease.
- •Psychiatric disorders or current alcoholism or drug abuse.
- •Drug abuse, smoking, abuse or addiction to alcohol.
- •Eating disorder such as bulimia or binge eating.
- •Endocrine abnormalities including stable thyroid disease.
- •Any major surgery, including cardiovascular surgery and surgery of oesophagus, stomach or duodenum, bariatric surgery
- •Subjects with open wounds
- •Subjects with injury involving skeletal system or deep soft tissue injury in last 3 months
- •Subjects on steroids or ergogenic users since past 3 months
- •Subjects who maybe allergic to any of the natural constituents of the Investigational Product
- •Pregnant and lactating women
- •Known HIV or Hepatitis B positive or any other immuno-compromised state
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- •Any additional conditions that in the Investigators opinion that may interfere with subject treatment, assessment or compliance with the protocol and would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Mean change in endurance, Isometric muscle strength and fatigue
时间窗: Baseline, Day 7, Day 14
次要结局
- Mean change in Biomarkers(Baseline, Day 7, Day 14)
研究者
Dr Mohan M E
BGS Global Institute of Medical Sciences
研究点 (1)
Loading locations...
相似试验
尚未招募
Phase 3 4
A Clinical Study to Investigate the Efficacy of a Multi-Strain Probiotic Formulation in Alleviating Symptoms of Anxiety,Insomnia and Depression.CTRI/2024/09/074094Unique Biotech Ltd.100
招募中
Phase 3 4
A Study to assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults with Functional ConstipationCTRI/2025/01/079362Vedic Lifesciences Pvt. Ltd126
尚未招募
Phase 3 4
A clinical study to evaluate Skin Health Benefits of Skin-ceraâ„¢ in Healthy Human VolunteersCTRI/2024/06/068757Vidya Herbs Pvt Ltd.80
尚未招募
Phase 3 4
A Clinical Study to Evaluate the effect of F-Biotic in Type 2 Diabetes Mellitus Subjects.CTRI/2024/03/063627Arishina Life Sciences Pvt. Ltd.70
招募中
不适用
A to assess the effect of ProGenr8 (Probiotic Supplement) on Immune Health in Teachers prone to Upper Respiratory Tract Infection (URTI)CTRI/2025/06/088564Vedic Lifesciences Pvt. Ltd100