Assessment of Becurie for management of Stress and Anxiety

Prospective Observational Double Blind Placebo Controlled Randomised Clinical Study to Assess the Stress and Anxiety Improvement with BeCurie - BECURIE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041445

Enrollment

Registered

2022-03-29

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: Suffering from moderate to severe stress and anxiety and Subjectively feel that they are stressed out or Work Burnout & itÃ¢â?¬•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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
The primary outcomes are the Improvements in Stress and Anxiety profile.Timepoint: Day 0, Day 30, Day 60 & Day 90.	—

Secondary

Measure	Time frame
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 TestsTimepoint: Day 0, Day 30, Day 60 and Day 90	—

Measure

Time frame

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 TestsTimepoint: Day 0, Day 30, Day 60 and Day 90

—

Countries

India

Contacts

Public ContactMr Shyam Sunder Pasumarthi

Yashoda Hospitals

mohankrishna88@gmail.com

Outcome results