Health Condition 1: F519- Sleep disorder not due to a substance or known physiological condition, unspecified Health Condition 2: F418- Other specified anxiety disorders
Conditions
Interventions
None listed
Sponsors
Mehta Ayurvedic Sansthan
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 to 65 years, male or female Body Mass Index (BMI 18 32 kg/m ) Clinically diagnosed anxiety disorder or depressive disorder according to DSM-5 or ICD-10 or 11 criteria Sleep disturbance secondary to anxiety and/or depression for at least 3 months prior to screening. Insomnia Severity Index (ISI) greater than or equal 15 at screening Moderate anxiety symptoms (GAD-7 score greater than or equal8) or moderate depressive symptoms (PHQ-9 score greater than or equal 10) at screening If receiving antidepressant or anxiolytic medication, must be on a stable dose for at least 6 weeks prior to screening. Willing to abstain from non-study cannabis products during the study period. Willing and able to complete sleep diaries and study questionnaires. Able and willing to provide written informed consent prior to initiation of any study-specific procedures and to comply with scheduled visits, assessments, and all study requirements
Exclusion criteria
Exclusion criteria: Severe major depression with suicidal ideation, psychotic features, or high suicide risk. History of schizophrenia, bipolar disorder, schizoaffective disorder, or cannabis-induced psychosis. Primary sleep disorders not related to anxiety/depression (e.g., untreated obstructive sleep apnea, narcolepsy, severe restless leg syndrome). Substance use disorder within the past 12 months (excluding nicotine and caffeine). Regular cannabis uses within 60 days prior to screening. Use of unstable doses of sedative-hypnotics, antipsychotics, opioids, or other CNS depressants within 6 weeks prior to screening. Significant uncontrolled medical illness (e.g., moderate to severe cardiovascular, hepatic, renal, or endocrine disease). Pregnant or lactating women, or women planning pregnancy during the study. Known allergy or hypersensitivity to cannabinoids or gummies Night-shift workers, drivers, machine operators, hazardous workers, or individuals with irregular sleep wake schedules Participation in another interventional clinical trial within the past 90 days. Cognitive impairment or any condition that would limit reliable participation or reporting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Insomnia Severity Index (ISI) score Change in depressive symptom severity using PHQ-9 score GAD-7 Generalized Anxiety Disorder Scale Jenkins Sleep Scale (JSS) Sleep parameters Sleep onset latency (minutes) Total sleep time (hours) Number of night awakenings Wake after sleep onset (minutes) SF-12 Questioners. Patient Global Impression of Change (PGIC)Timepoint: Baseline and day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate safety and tolerability of study product by clinical AEs (If any) Monitoring and documentation of adverse events throughout the studyTimepoint: Baseline and day 28 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
DK Elite Health Care Centre
Outcome results
None listed