| CTRI Number |
CTRI/2026/03/105163 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study in Healthy Volunteers to Evaluate a Non-Invasive Device for Detecting Marma Points of the Arm |
|
Scientific Title of Study
|
DESIGN AND DEVELOPMENT OF A NON-INVASIVE DEVICE FOR IDENTIFICATION OF MARMA OF UPPER LIMB |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Muchhadiya |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of PG and PhD studies in Shalya Tantra,
Parul institute of Ayurved,
Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara.
Department of PG and PhD studies in Shalya Tantra,
Parul institute of Ayurved,
Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
7874172301 |
| Fax |
|
| Email |
vishalmuchhadiya14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Hemant Toshikhane |
| Designation |
Principal and Dean |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of PG and PhD studies in Shalya Tantra,
Parul institute of Ayurved,
Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara.
Department of PG and PhD studies in Shalya Tantra,
Parul institute of Ayurved,
Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
hemant.toshikhane@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR Harish Daga |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of PG and PhD studies in Shalya Tantra,
Parul institute of Ayurved,
Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara.
Department of PG and PhD studies in Shalya Tantra,
Parul institute of Ayurved,
Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
9413662079 |
| Fax |
|
| Email |
harish.daga26839@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of PG and PhD studies in Shalya Tantra,Parul institute of Ayurved, Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara. Gujarat 391760, India |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Department of PG and PhD studies in Shalya Tantra,
Parul institute of Ayurved,
Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vishal N Muchhadiya |
Parul Institute of Ayurved |
Department of PG and PhD studies in Shalya Tantra,
Parul institute of Ayurved,
Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara.
Vadodara
GUJARAT |
7874172301
vishalmuchhadiya14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Parul Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Non-Invasive Upper Limb Marma Identification Scanning Procedure | (Procedure Reference: , Procedure details: A non-invasive diagnostic scanning procedure integrating infrared thermography, bioelectric impedance analysis, high-frequency ultrasound, & vascular response assessment for anatomical identification of upper limb Marma points.)
|
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged between18 - 60 years.
Healthy volunteers with no known musculoskeletal, neurological, or vascular pathology
BMI between 18.5 and 25 kg/m² to avoid excess fat affecting sensor readings
Willing to provide informed consent
No history of upper limb injury, surgery, or deformity.
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women
Participants with metallic implants, pacemakers, or prosthetics in the upper limb
Diagnosed with diabetes mellitus, neuropathy, Raynaud’s disease, or vascular disorders
Individuals with skin conditions or wounds at sensor application sites
Participants with high anxiety or movement disorders preventing steady measurement
Subjects who are currently undergoing any therapy (e.g., corticosteroids, physiotherapy) affecting circulation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy and reproducibility of upper limb Marma identification measured by positional deviation (mm), thermal asymmetry, impedance variation, and anatomical correlation via ultrasound. |
single study visit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Thermal, bioelectric, vascular, and sensory variations at detected Marma sites compared with adjacent non-Marma areas. |
single study visit. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/04/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a prospective, single-arm, interventional clinical study designed to evaluate the performance of a newly developed non-invasive diagnostic device for identification of Marma points of the upper limb. Marma are vital anatomical loci described in classical Ayurvedic literature, and their accurate identification in clinical practice remains largely subjective and dependent on practitioner expertise.The present study aims to standardize Marma localization using an objective device-based approach. The device will be applied to healthy participants, and identified Marma points will be compared with predefined anatomical landmarks and expert clinical assessment as reference standards.The primary objective is to assess the accuracy and reliability of the device in identifying upper limb Marma points. Secondary objectives include evaluation of reproducibility and inter-observer agreement. The study intends to generate preliminary evidence for the clinical applicability and standardization of Marma identification in contemporary practice. |