Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
Intervention1: Ashwagandha extract: Capsule KSM 66 300mg
One daily capsule for 90 days
The Ashwagandha root powder (grinded) contains around 0.5% with anolides (maximum). KSM 66 Ashwagandha root extr
Sponsors
Dr D Y Patil Medical College Hospital and Research Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of insomnia based on DSM-IV criteria 2. More than 30 minutes to fall asleep and subjective total sleep time of �6.5 hours per night (for at least 3 nights per week); and daytime complaints associated with disturbed sleep 3. Habitual bedtime between 8.30 pm to midnight 4. Body Mass Index between 16.5 to 30 kg/sq.m. 5. Subjects able to understand the sleep diary and are able to and willing to fill the sleep log diary and follow other procedures required by the study protocol 6. Subjects who sign the informed written consent
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening. 2. Known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, haematological or neurological illnesses. 3. Presence of any current psychiatric disorders that are judged by investigator as potentially causing or contributing to insomnia. 4. Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnea. 5. Substance dependence/ abuse in the past one year or with alcohol abuse are ineligible. 6. Those using tobacco products during night awakenings. 7. History of seizures or significant head trauma. 8. Subjects who travelled across four or more time zones or worked on night or rotating shifts in previous 7 days before study initiation or who plan to do the same during the study period. 9. Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis). 10. Any other investigational drug was used within three months prior the entry in this study. 11. Those who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Onset Latency (SOL)Timepoint: 6 wks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total sleep time (TST) by Actigraphy 2. Wake After Sleep Onset by Actigraphy 3. Sleep Efficiency, i.e. Total Time In Bed (TTIB) 4. Pittsburgh Sleep Quality Index (PSQI) 5. Change from baseline in number and duration of sleep interruptions (assessed by Sleep log) 6. Quality of sleep (Sleep log) 7. Day-time naps (Sleep log) 8. Nature of waking activities (Sleep log) 9. Mental alertness on rising 10. HAM-A score 11. Adverse eventsTimepoint: Baseline, 1 week, 3 weeks and 6 weeks | — |
Countries
India
Contacts
Public ContactDeepak Langade
Dr D Y Patil Medical College, Hospital And Research Center
Outcome results
None listed