Health Condition 1: G470- Insomnia
Conditions
Interventions
None listed
Sponsors
Dr Deodatta Bhadlikar
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 15 80 years (or include paediatric arm separately with proper ethics approval). 2.Diagnosed with insomnia disorder as per DSM-5 or ICSD-3 criteria with symptoms persisting for at least 3 months. 3.Sleep onset latency more than 30 minutes or total sleep duration less than 6 hours on average for at least 3 nights per week. 4.Willing and able to comply with study requirements including regular follow-ups sleep diary completion and assessments. 5.Able to provide informed consent (or assent with guardian consent in pediatric cases). 6.If on other medications or supplements: must be on a stable dose for at least 4 weeks prior to enrolment. For females of childbearing potential negative pregnancy test at screening and willingness to use contraception during the study.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity or allergy to any ingredient in Bravobo Forte Syrup. 2.History of major psychiatric disorders (e.g. schizophrenia bipolar disorder) unless stable and controlled. 3.Current use of strong sedative-hypnotic medications (e.g. benzodiazepines Z-drugs) that cannot be discontinued or tapered under supervision. 4.Substance or alcohol use disorder within the past 6 months. 5.Severe uncontrolled medical conditions such as: Uncontrolled hypertension Heart failure Liver or kidney dysfunction Severe respiratory disease (e.g. COPD untreated sleep apnea) 6.Neurological disorders such as epilepsy Parkinsons or Alzheimers unless included in a pre-defined observational subgroup. 7.Pregnant or breastfeeding women. 8.Participation in another clinical trial or use of an investigational product within the last 30 days. Shift workers or individuals with irregular sleep-wake schedules that could interfere with the assessment of insomnia-related outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the efficacy of Bravobo Forte Syrup in reducing sleep onset latency in individuals diagnosed with insomnia. To assess the impact of Bravobo Forte Syrup on total sleep duration as measured by subjective and objective sleep assessmentsTimepoint: 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the effect of Bravobo Forte Syrup on mood and emotional well-being including symptoms of anxiety and depression associated with insomnia. 2.To evaluate improvements in cognitive functioning such as attention memory and alertness in participants receiving Bravobol Forte Syrup.Timepoint: 60 days | — |
Countries
India
Contacts
Public ContactDr Devyani Bhadlikar
Sardar Ajit Singh Smriti Ayurveda Mahavidyalaya Raisen Road Bhopal Madhya Pradesh
Outcome results
None listed