Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
Intervention1: KSM-66 capsules containing
Ashwagandha 300 mg
standardized root extract: Standardized root extract 300
mg to be taken two times in a
day orally with water/milk for
period of 4 weeks
Int
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either gender, aged 18 to 50 years 2. Participants having insomnia characterized by the following criteria at the time of randomization: a) Diagnosis of insomnia based on DSM-IV criteria b) More than 30 minutes to fall asleep and subjective total sleep time of 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 willing to fill the sleep-log 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)- ActigraphyTimepoint: Baseline, 1 Week, 2 Weeks, 4 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Time In Bed (TTIB)- ActigraphyTimepoint: Baseline, 1 Week, 2 Weeks, 4 Weeks;Wake After Sleep Onset (WASO)- ActigraphyTimepoint: Baseline, 1 Week, 2 Weeks, 4 Weeks;Change from baseline in day-time napsTimepoint: 1 Week, 2 Weeks, 4 Weeks;Change from baseline in Mental alertness on risingTimepoint: 1 Week, 2 Weeks, 4 Weeks;Change from baseline in nature of waking activitiesTimepoint: 1 Week, 2 Weeks, 4 Weeks;Change from baseline in number and duration of Sleep interruptionsTimepoint: 1 Week, 2 Weeks, 4 Weeks;Change from baseline in quality of sleepTimepoint: 1 Week, 2 Weeks, 4 Weeks;Hamilton Anxiety Scale (HAM-A)Timepoint: 1 Week, 2 Weeks, 4 Weeks;Pittsburgh Sleep Quality Index (PSQI) ScoreTimepoint: Baseline, 1 Week, 2 Weeks, 4 Weeks;Total Sleep Time (TST)- ActigraphyTimepoint: Baseline, 1 Week, 2 Weeks, 4 Weeks | — |
Countries
India
Contacts
Public ContactDeepakkumar Langade
D Y Patil Medical College Hospital and Research Centre
Outcome results
None listed