Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: kaca kacaa kudineer: 60 ml of kaca kacaa kudineer at bedtime for 21 days
Control Intervention1: Lifestyle modifications: 60 ml of Kaca kacaa kudineer at bedtime for 21 days with lifesty
Sponsors
Government siddha medical college
Eligibility
Inclusion criteria
Inclusion criteria: Male and female aged 25 ââ?¬â?? 40 years. Insomnia Severity Index score >15.
Exclusion criteria
Exclusion criteria: ïÆ?Ë? Untreated cardiovascular disease, arrhythmias (other than well controlled atrial fibrillation), hypertension or severe heart failure ïÆ?Ë? History of allergies particularly to plant-based products containing terpenes, I.e. flavours and aromatic natural oils for example citrus, mango, lavender, thyme, cedarwood and pine products ïÆ?Ë? Currently regularly using (greater than or equal to 3 nights/days per week) psychotropic or CNS-active drugs (including cannabis, opioids, benzodiazepines) ïÆ?Ë? Inability to refrain from use of psychotropic or CNS-active drugs (including cannabis, opioids, benzodiazepines) for at least one week prior to and duration of study ïÆ?Ë? Inability to refrain from use of Cytochrome P450 inhibitors for at least one week prior to and duration of study. Examples include macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (itraconazole, ketoconazole, posaconazole, voriconazole), protease inhibitors (ritonavir, telaprevir, boceprevir), calcium channel blockers (amlopdipine), high cholesterol medication (gemfibrozil), cyclosporine, danazol, tachycardia medication (amiodarone), hypertension medication (verapamil, diltiazem), niacin (vitamin B3 greater than 1g/ day), grapefruit juice ïÆ?Ë? Untreated metabolic disorders such as diabetes ïÆ?Ë? Presence of severe depression, severe anxiety or other severe psychopathologic conditions. ïÆ?Ë? History of suicide attempt or current suicide ideation. ïÆ?Ë? History of seizures or epilepsy ïÆ?Ë? History of drug or alcohol abuse ïÆ?Ë? Insomnia associated with sleep apnea ïÆ?Ë? Are currently participating in a formal behavioural therapy program to facilitate sleep ïÆ?Ë? Pregnancy or lactation ïÆ?Ë? Inability to refrain from greater than 2 standard drinks/day of alcohol consumption for study duration ïÆ?Ë? Inability to refrain from greater than 400mg/day of caffeine consumption for study duration ïÆ?Ë? Any person required to drive within 10 hours of dose, or those with a self-reported history of falling asleep while driving ïÆ?Ë? Current delayed sleep phase syndrome where wake up time is regularly later than 8.00am.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome is mainly assessed by reduction in clinical symptoms measured by Insomnia severity indexTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the prevalence of chronic insomnia among it professionalsTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Nikil Niva J
government siddha medical college
Outcome results
None listed