Online ISSN: 2515-8260

A Prospective, randomized double-blind, placebo controlled study of safety and efficacy of HFSM-02 in reducing stress and anxiety in subjects with chronic medical condition and perceived stress.

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Dr. Veena Deo1 , Bharatbhushan Shrikhande2 , Dr. Gayatri Ganu3*, Dr. Nilesh chandrawanshi4

Abstract

Objective: Stress is a feeling of emotional or physical tension. It has now become a part of modern lifestyle. At some point in life, everyone must have encountered with some degrees of stress. It has negative impact of life and certain complications associated which includes increased risk of cardiovascular disease, elevating certain medical conditions like asthma, diabetes, hypertension, etc. Considering the increasing prevalence of stress and anxiety through multiple factors, there is a great need to find a solution to the existing problem. The current research depicts the safety and efficacy of HFSM-02 in reducing stress and anxiety in subjects with chronic medical condition and perceived stress. Material and methods: 120 subjects were enrolled in the study. Subjects were undergoing clinical examination. Vitals were recorded. Blood samples were collected for biochemical tests like change in serum cortisol levels. Subjective questionnaire scores evaluation were performed like POMS-2, and GHQ-28, questionnaire. Changes in symptoms severity were noted like disturbed sleep, and day time mood swings. Results: Reduction in stress hormone cortisol in healthy individuals, subjects with cardiovascular diseases (CVD) and diabetes mellitus (DM) was found to be 33.34%, 41.6% and 52.64% respectively. The reduction in DASS-21 and POMS-2 signifies the reduced stress levels. Conclusion: This explains that HFSM-02 can significantly reduce the stress hormone levels in healthy as well as moderately stressed subjects with diabetes and cardiovascular confounders.

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