CTRI/2023/04/052089已完成4 期
A Multicenter, Open Label, Prospective, Randomized, Comparative, Active Controlled, Two Arm Clinical Study to Evaluate and Compare the Effectiveness, and Safety of Herbobuild® Tablet and Plant Protein Supplement with Plant Protein Supplement alone in improving Muscle gain, Strength, and Recovery in Gym Going Healthy Adult Male Study Participants.
Herbolab India Pvt Ltd.0 个研究点目标入组 66 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Healthy male Study Participants aged between 18 to 30 years (both inclusive) at the first time of signing of the informed consent.
- •2. Completed the screening process within 3 days prior to Randomization.
- •3. Body mass index (BMI) between 18.5 kg/m2 to 24.9 kg/m2, inclusive calculated as (weight in kg) / (height in m)2 and weigh at least 50 kg.
- •4. Study participant has understood and signed the informed consent form to participate in the study.
- •5. Study participant willing to be available for the entire study period and to adhere to protocol requirements as evidenced by signing informed consent document.
- •6. Study participant with Gym experience of at least >6 months.
- •7. Study participant with Workout frequency of at least 3-5 days per week.
- •8. Study participant willing to abstain from use of vitamin or mineral supplements, nutritional supplements and or medical foods if applicable.
- •9. Judged by an investigator to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), vital sign assessments, laboratory reports, and by general observations.
- •10. Study participant with Waist Hip Circumference within 83 to 98 cm.
- •11. Study participant with Mid Arm Circumference within less than 23 cm to 25 cm.
- •12. Study participant with Muscular Strength Leg press 1RM and Bench Press 1 RM.
排除标准
- •1. Female Study Participants.
- •2. Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the investigator(s).
- •3. Systolic blood pressure less than 100 mmHg or more than 140 mmHg.
- •4. Diastolic blood pressure less than 60 mmHg or more than 90 mmHg. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the investigator.
- •5. Pulse rate below 60 beats/minute or above 100 beats/minute.
- •6. Reports smoking of more than 10 cigarettes/day, use of more than 4 packets/day of tobacco products or use of nicotine products (patches, gums, etc.) corresponding to more than 10 cigarettes/day or who are unable to abstain from smoking during the participation in the study.
- •7. Reports a history of drug or alcohol addiction or abuse within the past 1 year:
- •- Alcohol abuse defined as consumption of =21 units/week.
- •- One unit of alcohol equals 500 mL of beer; 200 mL of wine; or 50 mL of spirit.
- •8. Reports history or presence of hepatitis B surface antigen, hepatitis C antibody or HIV antibody per available laboratory report.
- •9. Reports a clinically significant illness during the 30 days prior to randomization (as determined by the investigator(s).
- •10. Reports a history of allergic response(s) to the active ingredient or related drugs.
- •Version 1.0, Final, Dated 27 January 2023
- •Confidential Page 21 of 49
- •11. Reports a history of clinically significant allergies including food or drug allergies.
- •12. Use of any prescription drug therapy or over the counter (OTC) drugs 14 days prior to receiving the first dose of study medication or repeated use of drugs within last 14 days.
- •13. Study participant with a history of any orthopaedic injury within the past 3 months.
- •14. Reports under any special diet.
- •15. Study Participant with active weight loss of >5 kg in past 3 months (intended or unintended).
- •16. Study Participant taking any medication, drugs, steroids, or protein supplements (excluding regular dietary protein) in any form to enhance the physical performance.
- •17. Any other condition, that in the investigator’s judgment, might compromise patient safety or affect study results.
研究者
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