| CTRI Number |
CTRI/2024/04/066380 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Wellness device] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Interventional Clinical Trail to prove the safety and efficacy of Muscle stimulation suit (wellness product) in healthy Volunteers having regual gym exercise habit |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| No Secondary Sponsor |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D D Keerthy Priya |
| Designation |
Consultant physiotherapist |
| Affiliation |
Anagha physiotherapy clinic |
| Address |
Anagha physiotherapy clinic,Ground Floor,Room No:1,Consultant Physiotherapist room,
Patamata Benz Circle Vijayawada Andhra Pradesh 520010
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
9666863999 |
| Fax |
|
| Email |
physio88dd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D D Keerthy Priya |
| Designation |
Consultant physiotherapist |
| Affiliation |
Anagha physiotherapy clinic |
| Address |
Patamata Benz Circle Vijayawada
Patamata Benz Circle Vijayawada Andhra Pradesh 520010
ANDHRA PRADESH
520010
India |
| Phone |
9666863999 |
| Fax |
|
| Email |
physio88dd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Koyya Gowtham Kumar |
| Designation |
Clinical Research Manager |
| Affiliation |
Fusion Clinical Research |
| Address |
Flat No GF2 TV SHARMA RESIDENCY SER CENTER ASHRAM STREET PRASADAMPADU VIJAYAWADA
Krishna
ANDHRA PRADESH
521108
India |
| Phone |
7893062708 |
| Fax |
|
| Email |
fusionresearchservices@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Craft My Strength Studio Pvt Ltd |
|
Primary Sponsor
Modification(s)
|
| Name |
Craft My Strength Studio Pvt Ltd |
| Address |
B81 Ridgewood Estate, DLF Phase -4 Gurgoan,India. |
| Type of Sponsor |
Other [Wellness Device Marketing Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| No Secondary Sponsor |
NA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D D Keerthi Priya |
Anagha physiotherapy clinic |
Department of Clinical Research,Room No:2,Anagha physiotherapy clinic,Patamata, Benz Circle, Vijayawada, Andhra Pradesh 520010
Krishna
ANDHRA PRADESH |
9666863999
physio88dd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Fusion Clinical |
Approved |
| Independent Ethics Committee - Fusion Clinical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers having regular gym habit |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Muscle Stimulation Suit with out Contraptions |
Body stimulation suit with out including Contraptions |
| Intervention |
Subjects Using Suit with contraptions-NoJetlag Compression pump Device |
Body stimulation suit with including Contraptions and the
study was designed to conduct on healthy vlountees with wearing body suit at the time of exercises and the body suit was considered as intervention product and the duration of intervention is total 8 times i.e 8 visits in 28 days for 30 min each visit |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 Analysis |
the outcome will be assessed and estimated at baseline visit
4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
Day 1 to day 28 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/05/2024 |
| Date of Study Completion (India) |
11/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 |