A Clinical Study of De-Stress & Chill Gummies in Reducing Stress

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria: 1. Male and female participants aged 21-50 years both inclusive 2. Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26 3. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form 4. 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 5. 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 Criteria: 1. Inability to perform any of the assessments required for endpoint analysis 2. 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) 3. Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress management 4. Have any other neurodegenerative diseases or seizure disorder 5. Known hypersensitivity to investigational products 6. Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy 7. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study 8. Sitting or resting systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg at screening 9. Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within the last 5 years 10. 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COPE Questionnaire;STAI (State-Trait Anxiety Inventory);visual analogue scale;Changes in serum cortisol levels;Change in serum serotonin levels;Changes in Modified sleep regularity and medication withdrawal questionnaire (MSRMWQ);Change in mood assessed using the Profile of Mood States (POMS);Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A);Perceived Stress Scale;Changes in Creatine kinase;Changes in Lactate dehydrogenase(LDH);Body Mass Index (BMI);Mental chatter 5-point scale

Secondary Outcome Measures

Name	Time	Method
Safety of participant Assessed using adverse events;Safety of participant Assessed using treatment compliance and tolerability of investigational product;Systolic blood pressure difference from reference measurement (mmHg);Diastolic blood pressure difference from reference measurement (mmHg);Pulse rate difference from reference measurement (beats per minute);Complete blood count;Serum Glutamic Pyruvic Transaminase (SGPT);serum glutamic-oxaloacetic transaminase (SGOT);Creatinine difference from reference measurement (mg/dl)