An Open label, Prospective, Single arm, Clinical Study to Evaluate the Safety and Efficacy of HSJS-092404 in Improving Exercise Performance in Healthy Adult Subjects.”
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in workout performance and muscle endurance using Push-up test.
研究概览
简要总结
| Participants will be examined for eligibility during the screening period after signing the informed consent form. An adequate number of participants who are Athletes, sports or fitness enthusiasts engaged in regular resistance training from last 6 months will be screened to enroll 50 participants, to have at least 40 evaluable participants. |
Participants will be enrolled based on study eligibility criteria (inclusion and exclusion criteria). After signing the informed consent form, eligible participants will be enrolled into the study. All the participants will be given IP on the same day(During screening visit). The date of first IP administration will be considered as Day1 and instructions about the dosage and timings will be given by Investigator as described in dosage & administration section.
Core Endpoints
Improvement in workout performance and muscle endurance using Push-up test.
Improvement in muscle strength & muscle recovery using Hand Grip Strength test.
Improvement in Energy, Stamina, Muscle Endurance, Strength, Muscle Recovery and Workout Performance through Subject Perception questionnaire.
There will be a total of 4 study visits for each participant.
Visit 1: Screening/Day 1
Visit 2: Day 30 ± 2 days
Visit 3: Day 60 ± 2 days
Visit 4: Day 90 ± 2 days/EOS
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •18-40 years predominantly males and fitness enthusiastic females.
- •Athletes, sports or fitness enthusiasts engaged in regular resistance training (comprising of cardio and strength training like pushups, bench press, leg press, squats etc) from last 6 months for at least 5 days in a week and willing to continue throughout the study duration.
- •Subjects who agree to perform physical activities as stated in the protocol.
- •Subjects who agree not to start any new therapies or energy boosting supplements or protein supplements or health drinks during the study.
- •Subjects who have not participated in any other similar clinical study in the last 3 months.
- •Subjects willing to sign informed consent and follow the study procedure.
- •7.Women of child-bearing potential must agree to use adequate contraception during study period 8.Male participants who are willing to refrain from donating sperm from first admission to the study until 90 days after the study completion.
排除标准
- •1.Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
- •2.Subjects with known clinically significant neurological, respiratory, cardiovascular, gastrointestinal, hepatic, congenital or any other chronic disorder that can interfere with the study conduct in the opinion of the Investigator.
- •3.Subjects with known history or present condition of allergic response to any of the ingredients in the investigational product.
- •4.Pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications or any other such as bleeding disorders.
- •5.Pregnant as assessed by UPT & History of Amenorrhea and lactating women.
- •6.Known history of drug abuse/dependency that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions, study procedures or follow-up guidelines.
- •7.Any other conditions (physical, psychological, social or uncontrolled dietary measures) that can interfere with the participant’s compliance to the study in the opinion of the Investigator.
结局指标
主要结局
Improvement in workout performance and muscle endurance using Push-up test.
时间窗: Visit 1: Screening/Day 1 | Visit 2: Day 30 ± 2 days | Visit 3: Day 60 ± 2 days | Visit 4: Day 90 ± 2 days
Improvement in muscle strength & muscle recovery using Hand Grip Strength test.
时间窗: Visit 1: Screening/Day 1 | Visit 2: Day 30 ± 2 days | Visit 3: Day 60 ± 2 days | Visit 4: Day 90 ± 2 days
Improvement in Energy Stamina Muscle Endurance Strength Muscle Recovery and Workout Performance through Subject Perception questionnaire.
时间窗: Visit 1: Screening/Day 1 | Visit 2: Day 30 ± 2 days | Visit 3: Day 60 ± 2 days | Visit 4: Day 90 ± 2 days
次要结局
- Assessment of safety of Investigational Product through General Physical Examination & Laboratory Investigations.(Incidence of adverse events during the study period.)