A prospective, Randomized, double blind, placeb controlled Clinical Trial to valuate the efficacy and safety of Ashwagandha product 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
- 60
- 试验地点
- 1
- 主要终点
- Primary Endpoints:
研究概览
简要总结
Ashwagandha contains a variety of bioactive compounds with significant therapeutic potential. Ashwagandha (Withania somnifera) is a powerhouse of bioactive compounds, each contributing to its extensive therapeutic potential. Among these, alkaloids such as withanine and somniferine are celebrated for their antioxidant, anti-inflammatory, and analgesic effects, offering diverse physiological benefits by reducing oxidative stress, modulating inflammatory pathways, and alleviating pain. The glycosides in Ashwagandha are represented by withanolides, a unique class of steroidal lactones. These compounds exhibit adaptogenic, anti-inflammatory, and anti-stress properties, helping the body manage stress, balance cortisol levels, and improve mental well being. Similarly, flavonoids, abundant in various plants, provide potent antioxidant and anti inflammatory effects, contributing to cardiovascular health by combating oxidative stress and improving vascular function. Saponins, another vital component, are known for their immune modulating and antioxidant properties, enhancing the body’s defense mechanisms while protecting cells from free radical damage.
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
- 18.00 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 at least 3 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.
- •Agree not to use any medication (prescription and over the counter), including vitamins and minerals, and any alternative medications during the course of this study.
- •Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range.
排除标准
- •1.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 beta agonists, Ketotifen, Theophylline or testosterone within 4 weeks before.
- •Participation in the current or previous clinical trial with any approved investigational products during the past 1 month.
结局指标
主要结局
Primary Endpoints:
时间窗: Day 0, Day 30 and Day 60
1.change from baseline muscle and connective tissue strength,
时间窗: Day 0, Day 30 and Day 60
assessed by one-repetition maximum (1-RM) bench and leg presses
时间窗: Day 0, Day 30 and Day 60
2.Handgrip strength (Dynamometer)
时间窗: Day 0, Day 30 and Day 60
3.Cable pull-down repetitions and pounds
时间窗: Day 0, Day 30 and Day 60
4.Time to exhaustion on a treadmill
时间窗: Day 0, Day 30 and Day 60
5.Mid-upper arm circumference (MUAC)
时间窗: Day 0, Day 30 and Day 60
6.The change from baseline testosterone assessed by free and total testosterone.
时间窗: Day 0, Day 30 and Day 60
7.Improvement in Muscle Strength, stamina and sustained energy level and the
时间窗: Day 0, Day 30 and Day 60
safety of Ashwagandha extract product and consumer acceptance through Self
时间窗: Day 0, Day 30 and Day 60
Assessment and Feedback questionnaires through Global Physical Activity
时间窗: Day 0, Day 30 and Day 60
Questionnaires
时间窗: Day 0, Day 30 and Day 60
次要结局
- 1.The improvement in Cortisol cycle from baseline is assessed by evaluating(Cortisol value)
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt Ltd