A Clinical Study of De-Stress & Chill Gummies in Reducing Stress (NCT06571071) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Study of De-Stress & Chill Gummies in Reducing Stress
72 participantsStarted 2024-09-05
Plain-language 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 suffer from a reduced quality of life, marked by symptoms such as irritability, fatigue, and difficulty concentrating. By integrating these gummies into their daily routine, many report noticeable improvements in their emotional and mental state. These enhancements can manifest as increased energy levels, better sleep quality, and a more balanced mood, which collectively contribute to a more positive outlook on life.
Who can participate
Age range21 Years ā 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Male and female participants aged 21-50 years both inclusive
ā. Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
ā. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form
ā. 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
ā. 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
Exclusion criteria
ā. Inability to perform any of the assessments required for endpoint analysis
ā. 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)
ā. Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress management
ā. Have any other neurodegenerative diseases or seizure disorder
ā
What they're measuring
1
Perceived Stress Scale
Timeframe: Screening, day 30, day 60
2
Changes in Creatine kinase
Timeframe: Screening, day 30, day 60
3
Changes in Lactate dehydrogenase(LDH)
Timeframe: Screening, day 30, day 60
4
Body Mass Index (BMI)
Timeframe: Screening, day 30, day 60
5
Mental chatter 5-point scale
Timeframe: Screening, day 30, day 60
6
Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A)