An Open label, Prospective, Two Arm, Clinical Study to Evaluate the Safety and Efficacy of HSHG-012601 in Improving Energy levels and Performance in Healthy Adults
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Protocol Number: HWC MSCD PP 066 2025 Version 10 Dated 14 Jan 2026
1 Study Title
An Open Label Prospective Two Arm Clinical Study To Evaluate The Safety And Efficacy Of HSHG 012601 In Improving Energy Levels And Performance In Healthy Adults
2 Study Type : Interventional
3 Investigational Product IP: HSHG 012601
5 Sample Size
Total Participants 60
Arm 1 30
Arm 2 30
6 Duration: Per Participant Duration 84 Days
7 Study Visits
Total 4 Scheduled Visits And Unscheduled As Needed
Visit 1 Screening Baseline
Visit 2 Day 28
Visit 3 Day 56
Visit 4 End Of Study Day 84
Unscheduled Visit As Required For Safety Clinical Reasons
8 Study Population
Healthy Males 18 To 45 Years
Fitness Enthusiasts Gym Goers Athletes Or Sports Enthusiasts
9 Study Design
Open Label
Prospective
Two Arm Clinical Study
10 Study Objectives
Primary Objective
To Evaluate The Safety And Efficacy Of HSHG 012601 In Healthy Adults
11 Study Endpoints
A. Objective Endpoints
Improvement In Workout Performance And Muscle Endurance Using Push Up Test At Visit 2 Visit 3 And End Of Study Compared To Baseline
Improvement In Muscle Strength And Post Workout Muscle Recovery Using Hand Grip Strength Test At Visit 2 Visit 3 And End Of Study Compared To Baseline
Supports Hormonal Regulation Testosterone And Cortisol
B. Subjective Endpoints
Improvement In Energy Stamina Endurance Strength Performance Fatigue Overall Wellbeing At Visit 2 Visit 3 And End Of Study Compared To Baseline
Improvement In Post Workout Recovery Using Likert Type Muscle Soreness And Muscle Fatigue Scale At Visit 2 Visit 3 And End Of Study Compared To Baseline
C. Safety Endpoints
Incidence Of Adverse Events
Gastrointestinal Symptom Rating Scale GSRS Reduction From Baseline
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •18 to 45 years fitness enthusiastic males.
- •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 atleast 5 days in a week and willing to continue through out the study duration.
- •Participants who agree to perform physical activities as stated in the protocol.
- •Participants who agree not to start any new therapies or energy boosting supplements or protein supplements or health drinks during the study.
- •Participants who have not participated in any other similar clinical study in the last 3 months.
- •Participants willing to sign informed consent and follow the study procedure.
- •Men with partners of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
- •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
- •Participants with physical impairments or musculoskeletal conditions that would significantly interfere with their ability to safely and reliably perform the functional performance assessments specified in this protocol.
- •Participants with known or clinically significant neurological, respiratory, cardiovascular, gastrointestinal, hepatic, or other chronic medical conditions that, in the opinion of the Investigator, could compromise participant safety or interfere with study conduct or outcome interpretation.
- •Participants with a known history of allergy or hypersensitivity to any ingredient of the investigational product.
- •Participants with pre-existing systemic diseases (e.g., autoimmune disorders, bleeding disorders) or those requiring long-term pharmacological treatment, including hormone replacement therapies, that could influence study outcomes or pose a safety risk, as determined by the Investigator.
- •Participants with a known history of substance abuse or dependency that, in the opinion of the Investigator, may limit their ability to comprehend informed consent or comply with study procedures, treatment instructions, or follow-up requirements.
- •Any other medical, psychological, social, or lifestyle-related conditions, including non-standardized dietary practices, that could interfere with participant compliance or affect study outcomes, as judged by the Investigator.
- •Participants who have used performance-enhancing supplements or substances, categorized as follows: a) Short-term or acute-effect supplements (e.g., pre-workouts, stimulant-based formulations, or ergogenic aids) within 1 week prior to screening; or b) Long-term anabolic or hormone-modulating substances (including but not limited to anabolic steroids, testosterone boosters, or growth hormone) within 8 to 12 weeks prior to screening, or during the study period.
- •Participants with a history of major surgery or hospitalization within the past 3–6 months, or those not fully recovered, as judged by the Investigator.
研究者
Dr Akshay Dhanda
Xplora Clinical Research Services Pvt Ltd