None listed
Conditions
Interventions
Intervention1: Muscle Stimulation Suit with Contaptions: Muscle Stimulation Suit with out Contaptions
Intervention2: Subjects Using Suit with contraptions-NoJetlag Compression pump Device: Body stimul
Sponsors
Craft My Strength Studio Pvt Ltd
No Secondary Sponsor
Eligibility
Inclusion criteria
Inclusion criteria: 1)Both Male and Female Subjects of age 18 yrs to 60 yrs 2) Subjects who are willing to sign the written informed consent. 3) Subjects BMI should be 18.5 to 29.5 kg/m2. 4)Women of childbearing potential must be using an acceptable method of contraception to avoid pregnancy throughout the study. 5)Women of childbearing potential must have a negative urine pregnancy test at screening visit. 6)Subjects willing to comply with all the protocol requirements. 7)Subjects who are having habbit of attending to gym for regular excersies
Exclusion criteria
Exclusion criteria: 1)Subjects with history of hypersensitivity to external body suits. 2)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. 4)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. 6)Female Subjects who are pregnant or lactating or planning to become pregnant during the study period. 7)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. 8)Subjects with known alcohol or other substance abuse within last one year. 9)Subjects with medical history of oncological conditions. 10)Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 11)Subjects with suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Evaluate the mean change in Body Composition AnalysisTimepoint: the outcome will be assessed and estimated at baseline visit 4 weeks and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. b) Improvement in Subject Quality of life using QOL questionnaires. c)Improvement in muscle strength of hand using Hand dynamometer readings d) Improvement in muscle strength of leg using Range of Motion for legs e)Improvement in Visual Analog scale Timepoint: Day 1 to day 28 | — |
Countries
India
Contacts
Public ContactKoyya Gowtham Kumar
Anagha physiotherapy clinic
Outcome results
None listed