None listed
Conditions
Interventions
Intervention1: Non-Invasive Smart Patch InnerGize: InnerGize is a non-invasive, safe and clinically tested device. InnerGize has gone through rigorous testing ensuring safety and maximum effectiveness
Sponsors
Ezymind Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female patients in the age group from 18 to 60 years. 2. Healthy volunteers stressed out due to the daily routine, work related for at least 2 weeks without receiving any alternative treatment in the past 3 months will be deemed suitable as per eligibility and will be approached regarding enrolment in the study. 3. Patients who are willing to provide a written informed consent form before initiation of the study. 4. Participants who are willing and able to comply with all study assessments and adhere to the protocol schedule.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating mother. 2. Patients with metallic and active implants in their body, such as pacemakers or hearing aids, should refrain from using the product 3. Patients with uncontrolled hypertension, cardiovascular diseases, or a history of Seizures 4. Significant systemic illness or occult systemic illness, or any other care or medication which may interfere with the InnerGize care 5. Not willing to obtain a written informed consent form to participate in the study. 6. Patients involved in clinical trials and taken similar investigational products within 3 months before initiation of the study. 7. Any severe, acute, or chronic medical condition that may affect the patients ability to participate in the study, may lead to unacceptable security risks and non-compliance with protocol procedures or may interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the performance outcomes like variations in stress, anxiousness and relaxation, experienced by Healthy Volunteers with the Non-Invasive Smart Patch InnerGize arm and a sham device arm throughout the study period.Timepoint: Day 1 - (Visit-I) Screening + Treatment - Pre stimulation + Post stimulation Day 2 - (Visit II) - Telephonic Follow up Day 3 - (Visit III) - Telephonic Follow up Day 4 - (Visit IV) - Telephonic Follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Customized questionnaire before the session (pre-stimulation) & after the session (post-stimulation) with Non-Invasive Smart Patch InnerGize & Sham device.Timepoint: Day 1 - (Visit-I) Screening & treatment Day 2 - (Visit II) - Telephonic Follow up Day 3 - (Visit III) - Telephonic Follow up Day 4 - (Visit IV) - Telephonic Follow up | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
CliniExperts Research Services Pvt. Ltd.
Outcome results
None listed