About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
De-Stress and Chill Gummies-U001
Other interventionTwo gummies in sequence daily after meal for 60 days
De-Stress and Chill Gummies-I001
Other interventionTwo gummies in sequence daily after meal for 60 days
Placebo Gummies-001
Other interventionTwo gummies in sequence daily after meal for 60 days
Treatment groups
Trial outcomes
Primary outcomes
Perceived Stress Scale
The PSS-10 is widely used for measuring psychological distress. It contains 10 questions on a five-point scale from 0 to 4. The higher the score, the greater the feeling of stress. PSS-10 Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Changes in Creatine kinase
Blood level of Creatine kinase was measured. (U/L)
Changes in Lactate dehydrogenase(LDH)
Blood level Lactate dehydrogenase of was measured. (U/L)
Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703
Secondary outcomes
Safety of participant Assessed using adverse events
It is measure in terms of No. of events
Safety of participant Assessed using treatment compliance and tolerability of investigational product
It is measure in terms of percentage
Systolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Diastolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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