None listed
Conditions
Interventions
Intervention1: ARC23004 - 60mg: Take 1 capsule of ARC23004 - 60mg before bed orally for 60 days.
Intervention2: ARC23004 - 120mg: Take 1 capsule of ARC23004 - 120mg before bed orally for 60 days.
Cont
Sponsors
Aurea Biolabs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subject with either gender, age between 18-65 (inclusive of both) years. 2) Subject having normal 12 lead ECG. 3) The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. 4) Subject having a score of at least 14 on the Perceived Stress Scale (PSS), free of psychiatric conditions other than stress. 5) Subjects who usually take more than 30 min to fall asleep and habitually take subjective total sleep time of less than or equal to 6.5 h per night (for at least 3 nights per week), having daytime complaints associated with disturbed sleep, having habitual bedtime between 8.30 p.m. to midnight, and contained Body Mass Index between 18.5 and 29.9 kg/sq. 6) Subjects who have given voluntary, written, informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Subjects suffering from any chronic physical, hormonal or psychiatric illness. 2) Subjects with uncontrolled type 2 diabetics, blood pressure and symptomatic hypotension and heart disease. 3) History of heart attack, stroke and coronary/cerebrovascular events. 4) Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease). 5) History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders. 6) Subjects with previous history of surgery. 7) Pregnant and lactating women. 8) Participation in any other clinical study using investigational medicinal product, herbal/ nutritional formulation or device within 3 months prior to baseline visit. 9) Subjects taking any of the following classes of medications: benzodiazepines, central nervous system depressants, diabetes medication, thyroid medication, immune suppressors, cardiovascular medication, any supplementations that impact on mood, stress, and sleep. 10) Subjects currently taking any herbal preparations, nutritional formulations, foods or formulations (including teas) containing valerian, chamomile, peppermint, mint, saffron, lavender, passionflower, lemon balm, tulsi, GABA, melatonin, theanine, magnesium, Ashwagandha, ginseng, ginkgo biloba, Brahmi or related herbs. 11) Subjects practicing lifestyle approaches such as yoga, breathing techniques, meditation, relaxation exercises, aromatherapy, relaxation tapes, etc to manage stress. 12) Subjects who regularly take stimulants including but not limited to coffee, tea, colas/ soda, caffeine, teacrine, paraxanthine, guarana, herbal stimulants, etc. 2-3 hours before bed time. 13) Subjects who live in an environment that results in disturbed sleep patterns, e.g., household with small children/ babies that need attention in the night, noisy neighbourhoods, etc. 14) Subjects working in shift work. 15) Unwilling to come for regular follow-up for the entire duration of the study. 16) Non – co-operative attitude of the subject. 17) Subjects with substance dependence including dependence on alcohol. 18) Subjects with allergies to any of the study product components. 19) Any condition that, in the opinion of the investigator, does not justify the subject’s inclusion for the study. 20) Excluding smokers since smoking can impact both perceived stress levels and sleep quality and anyone that consumes more than 2 drinks per day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Impact of ARC23004 on Hamilton Anxiety Rating Scale HAM-A 2) Impact of ARC23004 on Perceived Stress 3) Impact of ARC23004 on Sleep 4) Bond-Lader VAS (Mood Rating Scale) (BL-VAS)Timepoint: 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Hormonal changes in serum cortisol between 6-8 am and at 4 pm, Serotonin, dehydro epiandrosterone sulphate (DHEA-S) and testosterone.Timepoint: 60 days;2) Change in stress and anti-inflammatory biomarkers (Cortisol between 6-8 am and at 4 pm, C-reactive protein (CRP), IL-6, TNF-a).Timepoint: 60 days;3) Change in BP and pulse.Timepoint: 60 days;4) Fasting blood glucose.Timepoint: 60 days;5) Change in CBC and blood lipidsTimepoint: 60 days;6) To assess Global Quality of Life Scale.Timepoint: 60 days;7) To demonstrate safety and tolerability of study product by clinical monitoring of adverse events.Timepoint: 60 Days | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Service
Outcome results
None listed