| CTRI Number |
CTRI/2025/07/091925 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
This study will test whether the InnerGize smart patch is safe and works well in reducing stress and anxiety. It will compare the Sham Device patch in healthy volunteers to see if it helps people relax and manage stress better. |
|
Scientific Title of Study
|
An Investigator-Initiated Prospective, Open Labelled Comparative Study to Evaluate the Clinical Outcomes Like Performance, Effectiveness, and Safety of a Non-Invasive Smart Patch InnerGize and Sham device to Reduce Stress and Anxiousness and promote relaxation in Healthy Volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-CE-IG-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aradhana Kaul Kathju |
| Designation |
Consultant Psychologist |
| Affiliation |
Vasundhara Hospital Limited |
| Address |
Vasundhara Hospital Limited
Chamber 3, 4th Floor, Psychology department, Sector 11, II Chopasani Housing Board, Jodhpur 342008
Jodhpur
RAJASTHAN
342008
India |
| Phone |
9833049779 |
| Fax |
|
| Email |
aradhanakaulkathju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena RM |
| Designation |
Head - Medical Affairs |
| Affiliation |
CliniExperts Research Services Pvt. Ltd. |
| Address |
RMZ Galleria, 1st floor, Ambedkar Colony, Yelahanka, Bengaluru, Karnataka, India
Bangalore KARNATAKA 560064 India
Bangalore
KARNATAKA
560064
India |
| Phone |
9880902005 |
| Fax |
|
| Email |
veena.rm@cliniexpertsresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt. Ltd. |
| Address |
Unit No. 325, City Centre all, Plot No. 5, Sector 12, Dwarka, New Delhi, South West, DELHI - 110075
New Delhi
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
|
Source of Monetary or Material Support
|
| Ezymind Healthcare Private Limited |
|
|
Primary Sponsor
|
| Name |
Ezymind Healthcare Private Limited |
| Address |
Gat No. 1145 Flat No. c-401, Vagholi, Pune, Haveli, Maharashtra, India, 412207 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aradhana Kaul Kathju |
Vasundhara Hospital Limited |
Chamber 3, 4th Floor, Psychology department, Sector 11, II Chopasani Housing Board, Jodhpur 342008
Jodhpur
RAJASTHAN |
9833049779
aradhanakaulkathju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Ram Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
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. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 for the users. |
| Comparator Agent |
Sham device |
Its used as a control to compare the effectiveness of the active treatment.
Sham device is used to determine the effectiveness of a drug or treatment. Sham device / Placebos are inactive substances / material used to compare results with active substances / material.
It is similar as InnerGize (active device) but does not have frequency. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
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 Outcome
|
| Outcome |
TimePoints |
| Change in Customized questionnaire before the session ("pre-stimulation") & after the session ("post-stimulation") with Non-Invasive Smart Patch InnerGize & Sham device. |
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 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 primary objective of this study is to assess how the Non-Invasive Smart Patch InnerGize impacts various physiological and psychological outcomes, particularly focusing on changes in stress, anxiety, and relaxation levels among healthy volunteers. Participants will use the InnerGize patch, and their experiences will be compared to those using a sham device (a placebo device with no therapeutic effects) over the course of the study. By monitoring these variables, the study aims to determine the effectiveness of the Non-Invasive Smart Patch in reducing stress and anxiety while promoting relaxation. In addition to evaluating these performance outcomes, the study also seeks to examine the overall efficacy of the Non-Invasive Smart Patch InnerGize in comparison to the sham device, providing insight into how well the device works in real-world conditions. The study will also investigate the safety of the patch, ensuring that it does not cause any adverse effects or harm to the participants during the study period. Ultimately, the goal is to provide a comprehensive evaluation of both the benefits and risks associated with the use of the Non-Invasive Smart Patch InnerGize in comparison to a non-functional sham device. |