Status:
NOT_YET_RECRUITING
A Clinical Trial of De-stress and Focus Capsule in the Management of Stress.
Lead Sponsor:
Herbolab India Pvt. Ltd.
Conditions:
Anxiety
Stress
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The current study focuses in clinical validation of the efficacy of nutraceutical product in the management of mental focus and cognition. The benefits of these nutraceuticals extend beyond mere cogni...
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-arm clinical trial of De-Stress and Focus Capsule in the Management of Stress, Mental Alertness, Fatigue, and Anxiety In this study, m...
Eligibility Criteria
Inclusion
- Male and female participants aged 18-50 years both inclusive
- Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
- Scoring 18-26 on the Montreal Cognitive Assessment MoCA
- No or minimal impairment in activities of daily living: scoring less than 9 on the Functional Activities Questionnaire FAQ
- Participants willing to participate in clinical trials and who have read understood and signed the informed consent form
- No severe anxiety and depression on GAD and PHQ-9 scales
- Able to complete the cognitive assessment tests
Exclusion
- Inability to perform any of the assessments required for endpoint analysis
- Shows signs of Dementia, such as caused by Alzheimer's Disease, acquired immunodeficiency syndrome AIDS, Creutzfeldt-Jakob disease, Lewy Bodies dementia LBD, Cerebrovascular dementia CVD, Progressive Supranuclear Palsy PSP, multiple cerebral infarctions, or normal pressure hydrocephalus NPH, cardiac disease or endocrine disease
- Have any other neurodegenerative diseases
- History of a seizure disorder
- Known hypersensitivity to investigational products
- Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy
- Sitting or resting systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg at Screening.
- Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within the last 5 years
- Participants currently using medications and or supplements that could have cognitive or mood effects including but not limited to nutraceutical, allopathic, ayurvedic herbal extract or supplement
- Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
- Serious illness or any other condition that, in the opinion of the investigator may compromise the safety or compliance of the patient or preclude the successful completion of the study
Key Trial Info
Start Date :
September 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06569849
Start Date
September 5 2024
End Date
December 28 2024
Last Update
August 26 2024
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