Clinical Validation of the Potential of Herbal Extract Blend in Alleviating the Stress and Related Conditions: A Randomized, Placebo-Controlled, Cross-Over Clinical Study
Abstract
Background: The global rise in stress-related conditions has increased the demand for effective and safe interventions. This study aims to validate the efficacy of BacoZen™ blend tablets, an herbal blend of Ashwagandha extract and Brahmi extract, in alleviating stress. Methodology: A randomized, placebo-controlled, cross-over clinical trial was conducted with 64 subjects. Group A received BacoZen™ blend tablets for 4 weeks (Part I), followed by a 1-week washout period and placebo for 4 weeks (Part II). Group B received the interventions in reverse order. Assessments included perceived stress, cortisol, dopamine, sleep parameters, mood, fatigue, anxiety, and withdrawal symptoms. Results: The test group exhibited significant reductions in perceived stress (31.78%, 32.46%), cortisol levels, and improvements in dopamine levels, sleep quality, mood, fatigue and anxiety compared to the placebo group in both treatment parts. No adverse events or clinically significant changes in vital signs were reported, indicating excellent tolerability. The crossover design confirmed the intervention's consistent efficacy, independent of the sequence. Conclusion: BacoZen™ blend tablets containing herbal extracts Ashwagandha and Brahmi demonstrated robust and reproducible therapeutic effects in managing stress and anxiety, with an excellent safety profile. These promising results substantiate its potential as a safe and effective alternative to conventional interventions.
How strong is the evidence?
Evidence Hub reads this as a randomized trial. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 64 participants or records.
Read the paper
Related studies
- Cortisol, obesity and the metabolic syndrome: A cross-sectional study of obese subjects and review of the literature
- Relationships between lead biomarkers and diurnal salivary cortisol indices in pregnant women from Mexico City: a cross-sectional study
- Pubertal Recalibration of Cortisol Reactivity Following Early Life Stress: A Cross-Sectional Analysis
- High-end normal adrenocorticotropic hormone and cortisol levels are associated with specific cardiovascular risk factors in pediatric obesity: a cross-sectional study
- Effects of remote virtual work environment during COVID-19 pandemic on technostress among Menoufia University Staff, Egypt: a cross-sectional study
- Low serum albumin, aspartate aminotransferase, and body mass are risk factors for frailty in elderly people with diabetes–a cross-sectional study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.