A Clinical Trial of De-Stress & Snooze Gummies in Reducing Stress and Insomnia Disorder

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. Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders text revision DSM-V-TR 5. Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate 6. Participants with a diagnosis of mild or moderate depression patient's health questionnaire PHQ-9 score of less than or equal to 14 7. Participants with a diagnosis of mild or moderate generalized anxiety disorder GAD -7 questionnaire score of less than or equal to 10. Exclusion Criteria: 1. Difficulty sleeping due to a medical condition 2. History of a neurological disorder 3. History of bipolar disorder psychotic disorder or posttraumatic stress disorder or current psychiatric disorder that requires medication 4. On-going depression and generalized anxiety disorder diagnosis on PHQ 9 score greater than or equal to 15 and GAD-7 score greater than or equal to 11 scales 5. History of substance abuse or dependence 6. History or current evidence of a clinically significant cardiovascular disorder at pre-study visit 7. Taking certain prohibited medications 8. Consumption of greater than 10 cigarettes a day 9. Participants who consume greater than or equal to 120 mg/day of caffeine and are unwilling to restrict their intake throughout the study 10. Current evidence or history of malignancy less than or equal to 5 years prior to signing informed consent 11. Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress or insomnia management 12. Known hypersensitivity to any ingredients of product 13. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study 14. Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his her participation in and completion of the protocol.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perceived Stress Scale;Restorative Sleep Questionnaire Weekly Version (RSQ-W);Number of Participants Who Showed Improvement in Under Eye Dark Circle;visual analogue scale;Change in Sleep Efficiency;Changes in Modified sleep regularity and medication withdrawal questionnaire (MSRMWQ);Changes in serum cortisol levels;Change in serum serotonin levels;Change in FOSQ-10 score Profile of Mood State (POMS) questionnaire;Profile of Mood State (POMS) questionnaire;Changes in outcomes from participant sleep diary

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