CTRI Number	CTRI/2022/03/041445 [Registered on: 29/03/2022] Trial Registered Prospectively
Last Modified On:	01/09/2022
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	Other (Specify) [General Wellness Wearable]
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study	Assessment of Becurie for management of Stress and Anxiety
Scientific Title of Study	Prospective Observational Double Blind Placebo Controlled Randomised Clinical Study to Assess the Stress and Anxiety Improvement with BeCurie
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Mohan Krishna Narasimha Kumar Jonnalagadda  Address  Yashoda Hospitals, Raj Bhavan Road, Somajiguda, Hyderabad, Telangana State Hyderabad TELANGANA 500081 India  Phone     Fax     Email  mohankrishna88@gmail.com
Details Contact Person Scientific Query	Name  Dr Mohan Krishna Narasimha Kumar Jonnalagadda  Address  Yashoda Hospitals, Raj Bhavan Road, Somajiguda, Hyderabad, Telangana State Hyderabad TELANGANA 500081 India  Phone     Fax     Email  mohankrishna88@gmail.com
Details Contact Person Public Query	Name  Mr Shyam Sunder Pasumarthi  Address  5th Floor, Octave Block, Gate No 2. Salarpuria Sattva, Knowledge Park, Hitech City Rd, Hyderabad, Telangana Hyderabad TELANGANA 500081 India  Phone     Fax     Email  pvshyam@innopark.in
Source of Monetary or Material Support	INNOPARK INDIA PVT LTD
Primary Sponsor	Name  Innopark India Pvt Ltd  Address  5th Floor, Octave Block, Gate No 2. Salarpuria Sattva, Knowledge Park, Hitech City Rd, Hyderabad, Telangana 500081  Type of Sponsor  Other [Private Company]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Mohan Krishna Narasimha Kumar Jonnalagadda   Yashoda Hospital  Department: Neurology Division: Neurology-OP Room NO: 222 Raj Bhavan Rd, Matha Nagar, Somajiguda, Hyderabad, Telangana , 500082 Hyderabad   04045674567 mohankrishna88@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  YASHODA ACADEMY OF MEDICAL EDUCATION AND RESEARCH  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Participants with moderate to severe stress and anxiety.
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  BECURIE Device  BeCurie generates ultra-low frequency magneto-electric waves within the range between 1 milli Gauss to 10 milli Gauss, very similar to the electrical waves generated in the brain under harmonic state (unagitated state). The device is programmed to generate variable magnetic fields based on the therapeutic indication. This study is specific to the program meant to tackle stress and anxiety (10 mG). This device is connected to the smartphone via Bluetooth and android application to monitor the usage and compliance. This is a Observational randomised double blind placebo controlled trial as approved by the ethics committee of Yashoda Hospital The duration of the study will be 3 months where the subject will wear the device for the entire duration of the study (as per the protocol approved by ethics committee). Becurie Device generates headphones equivalent weak magnetic field around 10 milli Gauss. Not considered as a regulated device under current medical device regulations.
Inclusion Criteria	Age From  18.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  Suffering from moderate to severe stress and anxiety and Subjectively feel that they are stressed out or Work Burnout & it’s affecting their Quality of life. Assessed through DASS-21 Minimum Threshold Score for moderate anxiety : 10-14 Minimum Threshold Score for moderate stress : 19-25
ExclusionCriteria	Details  Age below 18 years or above 60 years Subject unable to read and write Having history of chronic drug or alcohol abuse Skin related disorders Using antipsychotic drugs Pregnant women or lactating women Contraindications to the product under investigation (skin irritability or allergy to electrode glue implanted devices as pacemakers or defibrillators) Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant A history of a serious medical condition such as head and neck cancer or skin cancer (all other cancers). History of allergy or hypersensitivity to any medical device or its components.
Method of Generating Random Sequence	Permuted block randomization, fixed
Method of Concealment	An Open list of random numbers
Blinding/Masking	Participant and Investigator Blinded
Primary Outcome	Outcome  TimePoints  The primary outcomes are the Improvements in Stress and Anxiety profile.  Day 0, Day 30, Day 60 & Day 90.
Secondary Outcome	Outcome  TimePoints  The secondary outcomes will be improvements in: 1.Recording of physiological parameters Pulse BP BMI 2.Baseline EEG a) Frontal and Temporal Alpha and Beta asymmetry b) Alpha Symmetry 3.Blood parameters including a) Cortisol b) Melatonin c) Blood analysis includes, Haematology Hemoglobin Packed Cell Volume Red Blood Cells Mean Corpuscular Hemoglobin Concentration Mean Corpuscular Volume Mean Corpuscular Hemoglobin Total White Blood Cells Differential Count Complete Urine Examination Erythrocyte Sedimentation Rate Platelet Count 4) Biochemistry HbA1C Creatinine Serum Lipid Profile Serum Calcium Urea and Uric acid Liver Function Tests   Day 0, Day 30, Day 60 and Day 90
Target Sample Size	Total Sample Size="45" Sample Size from India="45"
Phase of Trial Modification(s)	Phase 3
Date of First Enrollment (India)	31/03/2022
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	NIL
Brief Summary	Occasional anxiety is an expected part of life. But anxiety disorders involve more than temporary worry or fear. The symptoms can interfere with daily activities such as job performance, school work, and relationships. Low frequency magneto-electric field exposure studies have shown some promising results in supporting/treating brain related illnesses in the recent years with little to no side effects, recorded till date. This particular study is focussed to evaluate the efficacy of Becurie device (generates ultra-low magneto-electric waves with 10 milli Gauss), in improving the symptoms of Stress and Anxiety in participants, thereby improving the quality of life.