A Randomized, two armed, double blind, placebo controlled Clinical Trial to evaluate the efficacy and safety of NS2128E03 in the improvement of Muscle strength and endurance in healthy male subjects.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. The change from baseline muscle strength, assessed by one-repetition maximum (1-RM) bench and leg presses, and handgrip strength (Dynamometer).
研究概览
简要总结
NS2128E03 is a blend of Tamarindus indica seeds extract and Moringa oleifera leaves extract.Both these extracts have been achieved using regulatory approved safe solvents, ethanol and water.Tamaridus indica and Moringa oleifera are used in food preparations and consumed in various countries on regular basis. Based on the In-vivo efficacy study, NESSO desires to conduct a Human efficacy study (Clinical trial) to evaluate the effect of this blend on improving exercise
efficiency and Testosterone levels.
Here, based on the In-vitro and In-vivo efficacy studies, NESSO has developed a synergistic combination of Tamarind seed extract and Moringa leaf extract to enhance the Testosterone levels in individuals. This will boost the exercise efficiency in subjects leading to better muscle performance and endurance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male volunteers between the age group of 25-45 years.
- •Subjects who are familiar with weight training and had atleast 4 months of experience in the gym (defined as 4 times per week for minimum of 3 to 4 hours per week).
- •Subjects who are willing and able to understand and follow the protocol and provide informed consent.
- •Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range.
排除标准
- •Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, hematological, neurological, immunological)
- •Patients with pre-existing severe systemic disease necessitating long-term medication.
- •Subjects suffering from any serious medical or surgical illness.
- •History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ.
- •Any neurological (congenital or acquired), musculoskeletal, joint health conditions, psychological, vascular or systemic disorder which could affect any of the efficacy assessments.
- •Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate), ECG hematology, serum chemistry.
- •More than 4 short courses of oral corticosteroids within the year preceding the screening visit, or any oral corticosteroids in the preceding 4 weeks.
- •Use of Astemizole, Nedocromil, Cromolyn, long acting β agonists, Ketotifen, Theophylline or testosterone within 4 weeks before.
- •Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.
结局指标
主要结局
1. The change from baseline muscle strength, assessed by one-repetition maximum (1-RM) bench and leg presses, and handgrip strength (Dynamometer).
时间窗: Day 0, Day 15,Day 30 and Day 60
2. Cable pull-down repetitions, time to exhaustion on a treadmill, mid-upper arm circumference (MUAC) and free and total testosterone levels in serum.
时间窗: Day 0, Day 15,Day 30 and Day 60
次要结局
- 1. safety of NS2128E03 and consumer acceptance through feedback questionnaires.(2. Adverse events (AEs).)
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt Ltd