A Clinical Study to Assess the Safety and Effectiveness of Herbal Supplement in Adult Human Subje… (NCT05853757) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Assess the Safety and Effectiveness of Herbal Supplement in Adult Human Subjects.
India32 participantsStarted 2023-04-17
Plain-language summary
A proof of science/concept clinical study with single-arm, single-blind, to evaluate safety, efficacy and in-use tolerability study of Herbal Supplement in adult human subjects having difficulty in falling asleep.
A total of up to 32 subject will be enrolled to get 30 completed subject in the study.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: 18 to 65 years (both inclusive) at the time of consent.
✓. Sex: Healthy non-pregnant/non-lactating females and males.
✓. Subject having difficulty in falling asleep due to shift work disturbance, jet lag, mental stress.
✓. Female of childbearing potential must a reported negative pregnancy test, agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
✓. Subject is generally in good health.
✓. Subjects who having \> 30 minutes to fall asleep and subjective total sleep time of is 6.5 hours per night (for at least 3 nights per week); and daytime complaints associated with disturbed sleep.
✓. Habitual bedtime between 8.30 pm to midnight.
✓. Subject is willing to give written informed consent and are willing to follow the study procedure.
Exclusion criteria
✕. Subject has a history of allergy or sensitivity to the test treatment ingredients like melatonin, Tagar, minerals etc.
✕. Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnoea.
✕. Subject who are substance dependence/ abuse in the past one year or with alcohol abuse.
What they're measuring
1
Change in quality of sleep
Timeframe: From Baseline Day 01 (before usage) and Day 15 (post usage)
2
Change in duration sleep
Timeframe: From Baseline Day 01 (before usage) and Day 15 (post usage)
. Subject who are using tobacco products during night awakenings.
✕. Subject with history of seizures or significant head trauma.
✕. Subject worked on night or rotating shifts in previous 7 days before study initiation or who plan to do the same during the study period.
✕. Subject Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis).