Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
Intervention1: SDA-217: One tablet of 1200 mg daily (OD), in night 30 minutes before going to bed for 3 months
Control Intervention1: Placebo: One tablet of 1200 mg daily (OD), in night 30 minutes bef
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Has had chronic insomnia for at least 3 months 2. Has Insomnia Severity Index (ISI) >14 3. Not improving with standard of care for management of Insomnia (CBT ?I, psychotherapy, behavioral therapy or single drug pharmacotherapy) for at least after 8 weeks of therapy 4. should be following sleep hygiene principles 5. has given informed consent prior to any study related procedure
Exclusion criteria
Exclusion criteria: 1. Patients of obstructive sleep apnea (OSA) with AHI or RDI index more than 15 2. Patients with major depressive disorder, severe psychosis, significant anxiety disorder and any other neurological diseases 3. The non ?ambulatory chronic insomnia patients with comorbidities of terminal ?stage illness such as cancer, HIV, ESRD or cardiovascular diseases etc. 4. Pregnant and breast ?feeding women (Females of childbearing potential who are sexually active must agree to use adequate contraception) 5. Patients of shift workers and patients with irregular bed time habits (deviation of more than 4 hrs for more than 2 times a week) 6. Patients who are taking antidepressant drugs for more than 1 month (SSRIs eg. fluoxetine, paroxetine, sertraline, citalopram, escitalopram, fluvoxamine, monoamine oxidase (MAO) inhibitors, venlafaxine and duloxetine etc) 7. Patients who are taking CNS stimulants (eg. methylphenidate, amphetamine and derivatives, ephedrine and derivatives, cocaine), decongestants (e.g. pseudoephedrine, phenylephrine, phenylpropanolamine), narcotic analgesics (eg. oxycodone, codeine, propoxyphene), cardiovascular (a ?receptor agonists and antagonists),diuretics and bronchodilators (theophylline, albuterol), respiratory stimulants, over ?the ?counter and prescription stimulants 8. Patients who are currently taking sedating H1 antihistaminics, systemic steroids, antipsychotics, muscle relaxants, melatonin and all other drugs or supplements known to affect sleep/wake function 9. Patients who are taking any caffeinated drinks (caffeine >90 mg or tea and coffee more than 3 cups) after 4 pm 10. Patients with history of alcohol abuse within the past 3 months 11. Patients with history of drug abuse within the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polysomnography based improvement in sleep efficiencyTimepoint: Before and after 90 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Impreovement in sleep architectureTimepoint: Before and after 90 days of treatment;Improvement in Insomnia questionnaires and quality of lifeTimepoint: 0 day, 30 days, 60 days, 90 days, 105 days & 145 days | — |
Countries
India
Contacts
Public ContactDr Satyapal Singh Yadav
Indian Council of Medical Research
Outcome results
None listed