Ganmaidazao Concentrated Beverage Sleep-Assisting Trial
ConditionSleep
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSirio Pharma Co., Ltd
About this trial
A human trial with blind method and self-control design was carried out to evaluate the sleep-improving function of a food. Indicators were detected by professional instruments and self-assessed by subjects. Relevant data before and after 28 consecutive days of test sample administration were collected for comparative analysis.
Eligibility criteria
Qualifiers
Aged 18 to 60 years of any gender, with a history of staying up late or mild sleep disorder, and Pittsburgh Sleep Quality Index (PSQI) score between 7 and 15 points (mild to moderate sleep impairment).
Regular daily schedule with bedtime from 22:00 to 24:30 and wake-up time from 6:30 to 8:30; long-term daily schedule fluctuation ≤ 2 hours, and able to maintain a fixed schedule throughout the trial.
No abnormal saliva secretion and capable of completing saliva sample collection independently and normally.
Body Mass Index (BMI) ranging from 18.5 to 28.0, without extreme emaciation or obesity.
Disqualifiers
Aged under 18 years or over 60 years.
Current smokers, or subjects with alcohol drinking habits of ≥3 times per week who have not quit alcohol within one month before the trial.
Long-term intake of stimulating beverages, defined as drinking strong tea, coffee or energy drinks ≥3 cups per day.
Experienced drastic changes in diet or daily routine within one month before enrollment, such as frequent business trips, travel, shift work, or dramatic dietary habit changes.
Trial design
Treatments tested in this trial
- Sleep-improving Functional Food
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov