A Clinical Trial of De-Stress & Snooze Gummies in Reducing Stress and Insomnia Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-50
SponsorHerbolab India Pvt. Ltd.
About this trial
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 good night's sleep, individuals often find themselves more alert, focused, and better equipped to handle complex tasks and problem-solving scenarios. This can enhance productivity at work, as well as improve the ability to engage in meaningful conversations and activities. Memory consolidation, which occurs during sleep, is also optimized, leading to better retention of information and a sharper mind.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- De-Stress & Snooze Gummies-U001
- De-Stress & Snooze Gummies-I001
- Placebo Gummies 002
Treatment groups
60 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov