Health Condition 1: F411- Generalized anxiety disorder
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Adults aged 18 to 65 years with mild to moderate symptoms of insomnia (Insomnia Severity Index: score 8 to 21) 2. Female subjects of child-bearing potential to use a reliable method of contraception 1 month before and throughout the study period to avoid pregnancy. 3. Willing to sign inform consent document and abide by the study procedures.
Exclusion criteria
Exclusion criteria: 1.Subjects who do not refrain from taking alcohol or any medications or preparations to improve sleep (dietary supplements, homeopathic preparations, etc.) during the study. 2.Subjects with known sleep disorders: narcolepsy, obstructive sleep apnea, circadian rhythm disorder (like night, early morning & rotational shift workers, jet lag disorder) and parasomnia. 3.Subjects with known psychiatric diagnosis attributable as causing insomnia like schizophrenia, dementia or cognitive impairment. 4.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids like prednisone, opioid pain relievers, hypnotics, and/or prescribed other regular sleep medication. 5.Subjects severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year). 6.Subjects with ongoing medications that may be considered contributory to insomnia like psychostimulants, amphitamines, cold medicines/ decongestants (like oxymetazoline), beta-agonist, theophylline, caffeine, and any other as determined by the investigator 7. Subjects with uncontrolled chronic diseases such as Diabetes, Hypertension that are considered clinically significant by the investigator 8.Pregnant or lactating women. 9.Recreational drug users (including history within last 2 years) 10. Subjects with alcohol dependence. CAGE score value more than or equal to 2, Appendix 4, applicable only for subjects with history of alcohol intake) 11.Participation in another study with any investigational product within 30 days prior to screening. 12.Subjects having any abnormality in any one of the laboratory & other investigations which are considered clinically significant by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Change from baseline in sleep quality, SOL, TST, SE, Frequency of awakenings, Use of sleep medications & daytime dysfunction assessed by Pittsburgh Sleep Quality Index (PSQI) assessed by Investigator •Proportion of subjects showing improvement in Insomnia severity index (ISI) from baseline and change from baseline score of ISI assessed by Investigator. •Change from baseline in sleep quality, SOL, TST, SE, Frequency of awakenings, Use of sleep medications & daytime sleepiness, tiredness, irritability by subjective assessment questionnaire. Timepoint: Day 7, Day 14, Day 35 and Day 63 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Incidence of any adverse or serious adverse events reported or observed during the study period. • Proportion of subjects withdrawing from trial because of adverse events (tolerability). • Compliance of the subject to the study medication. Timepoint: Day 7, Day 14, Day 35 and Day 63 | — |
Countries
India
Contacts
Public ContactKavitha Rangaiah
Himalaya Wellness Company
Outcome results
None listed