Status:
NOT_YET_RECRUITING
A Clinical Study of De-Stress & Chill Gummies in Reducing Stress
Lead Sponsor:
Herbolab India Pvt. Ltd.
Conditions:
Stress
Anxiety
Eligibility:
All Genders
21-50 years
Phase:
NA
Brief Summary
The current study focuses on clinical validation of efficacy of nutraceutical product in reduction of stress,anxiety and improving mood in adults. Adults experiencing chronic stress and anxiety often ...
Detailed Description
This is a randomized, double-blind, parallel-arm, comparative, multicenter, placebo-controlled, clinical trial of De-Stress and Chill Gummies in reducing stress and anxiety, and improving mood in adul...
Eligibility Criteria
Inclusion
- Male and female participants aged 21-50 years both inclusive
- Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
- Participants willing to participate in clinical trials and who have read understood and signed the informed consent form
- No severe anxiety and depression i.e. Generalized anxiety disorder GAD score less than or equal to 10 and Patients' health questionnaire-9 PHQ-9 score less than or equal to 14
- A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout the study period 6 No history of substance use disorder other than the use of nicotine and recreational use of alcohol not having used for the last 14 days and consenting not to use the same during the period of the trial
- 7\. Willing to limit caffeine consumption while in the study.
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 (CJD), Lewy Bodies dementia (LBD), Cerebrovascular dementia (CVD), Progressive Supranuclear Palsy (PSP), multiple cerebral infarctions, or normal pressure hydrocephalus (NPH)
- Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress management
- Have any other neurodegenerative diseases or seizure disorder
- Known hypersensitivity to investigational products
- Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy
- Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
- 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
- Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant 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 :
72 Patients enrolled
Trial Details
Trial ID
NCT06571071
Start Date
September 5 2024
End Date
December 28 2024
Last Update
August 26 2024
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