CTRI/2024/04/066380已完成不适用
A open label two arms randomized parallel group clinical trial to evaluate the efficacy and safety of Muscle Stimulation Suit in healthy volunteers having habit of regular gym exercises
Craft My Strength Studio Pvt Ltd1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年5月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- The Primary end point is to Evaluate the mean change in CBP and Serum Electrolyte Levels from base line visit to end of the study visit and to
研究概览
简要总结
The study title "A open label, two arms, randomized, parallel group clinical trial to evaluate the efficacy and safety of Muscle Stimulation Suit in healthy volunteers having habbit of regular gym exercises",was an interventional ,proof of concept study designed for wellness device & planned to prove the efficacy and safety of device on a healthy volunteers having regular gym habbit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Both Male and Female Subjects of age 18 yrs to 60 yrs 2) Subjects who are willing to sign the written informed consent.
- •Subjects BMI should be 18.5 to 29.5 kg/m
- •Women of childbearing potential must be using an acceptable method of contraception to avoid pregnancy throughout the study.
- •Women of childbearing potential must have a negative urine pregnancy test at screening visit.
- •Subjects willing to comply with all the protocol requirements.
- •Subjects who are having habbit of attending to gym for regular excersies.
排除标准
- •Subjects with history of hypersensitivity to external body suits.
- •Subjects with uncontrolled hypertension with sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening visit 3)Subjects with history of clinically significant medical illness in past 3 months, such as cardiovascular disease (e.g., myocardial infarction and orthostatic hypotension), falls and syncope, central nervous system diseases (e.g., seizure, bipolar disorder, depression and generalized anxiety disorder), liver disease, angioedema, peripheral edema, angle-closure glaucoma, urinary retention and bleeding disorder or any other disorder which may compromise safety of patient as per investigator discretion.
- •Subjects who underwent for ortho surgeries with having any type of implants in the body 5)Subjects with history of compromised respiratory function or respiratory diseases.
- •Female Subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Female subjects who are of childbearing potential and who are neither surgically sterilized nor willing to use medically acceptable contraceptive methods (sexual abstinence, hormonal, barrier methods or intrauterine device) during the study.
- •Subjects with known alcohol or other substance abuse within last one year.
- •Subjects with medical history of oncological conditions.
- •Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •Subjects with suspected inability or unwillingness to comply with the study procedures.
结局指标
主要结局
The Primary end point is to Evaluate the mean change in CBP and Serum Electrolyte Levels from base line visit to end of the study visit and to
时间窗: the outcome will be assessed and estimated at baseline visit | 4 weeks and 8 weeks
Evaluate the mean change in Body Composition Analysis
时间窗: the outcome will be assessed and estimated at baseline visit | 4 weeks and 8 weeks
次要结局
- The secondary end point is to(a)Evaluate the mean change in weight lifting capacity at least 15% more in overall population from baseline visit to end of the visit.)
研究者
Dr D D Keerthy Priya
Anagha physiotherapy clinic
研究点 (1)
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