Status:
NOT_YET_RECRUITING
A Clinical Trial of De-Stress & Snooze Gummies in Reducing Stress and Insomnia Disorder
Lead Sponsor:
Herbolab India Pvt. Ltd.
Conditions:
Stress
Insomnia
Eligibility:
All Genders
21-50 years
Phase:
NA
Brief Summary
The current study focuses on clinical validation of efficacy of nutraceutical product in management of sleep disorder. Improved sleep quality contributes significantly to cognitive function. With a go...
Detailed Description
A randomized, double-blind, placebo-controlled clinical trial of De-Stress and Snooze Gummies in reducing stress, insomnia disorder, associated symptoms, and overall quality of life. More than 60 Par...
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
- Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders text revision DSM-V-TR
- Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate
- Participants with a diagnosis of mild or moderate depression patient's health questionnaire PHQ-9 score of less than or equal to 14
- Participants with a diagnosis of mild or moderate generalized anxiety disorder GAD -7 questionnaire score of less than or equal to 10.
Exclusion
- Difficulty sleeping due to a medical condition
- History of a neurological disorder
- History of bipolar disorder psychotic disorder or posttraumatic stress disorder or current psychiatric disorder that requires medication
- 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
- History of substance abuse or dependence
- History or current evidence of a clinically significant cardiovascular disorder at pre-study visit
- Taking certain prohibited medications
- Consumption of greater than 10 cigarettes a day
- Participants who consume greater than or equal to 120 mg/day of caffeine and are unwilling to restrict their intake throughout the study
- Current evidence or history of malignancy less than or equal to 5 years prior to signing informed consent
- Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress or insomnia management
- Known hypersensitivity to any ingredients of product
- Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
- 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.
Key Trial Info
Start Date :
September 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06571331
Start Date
September 5 2024
End Date
December 28 2024
Last Update
August 26 2024
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