Ganmaidazao Concentrated Beverage Sleep-Assisting Trial

Starting soon · Not applicable

Conditions studied: Sleep

In brief

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.

Key facts

Study ID

NCT07726719

Run by

Sirio Pharma Co., Ltd

People needed

25

Starts

2026-08-01

Expected to finish

2026-10-30

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Able to participate in pre-trial centralized training and operational assessments (including wearable bracelet wearing, saliva collection, and questionnaire filling), and pass the assessment before enrollment.
• No intake of sleep aids, anti-anxiety drugs, antidepressants, central nervous system regulators, sleep-improving health foods and related products within 2 weeks prior to enrollment.
• Free from severe organic diseases, including cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, psychiatric disorders, and nervous system diseases.
• Free from severe sleep disorder subtypes, such as obstructive sleep apnea syndrome.
• No history of allergy to the ingredients and excipients of the test product, and voluntarily sign the informed consent form.

You may not qualify if…

• 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.
• Diagnosed with severe sleep disorders or obstructive sleep apnea syndrome.
• Participated in other human clinical trials, received professional sleep intervention therapy, or consumed products containing N-acetylneuraminic acid within one month before enrollment.
• Pregnant or lactating females, or those planning to become pregnant within one year.
• Long-term shift workers, regular severe night owls, or subjects with extremely unstable sleeping environments.
• Intolerant to wearing smart wearable bracelets or unable to cooperate with trial-related examinations and sample collection.
• Staff of the trial institution and other personnel involved in this project.
• Scheduled to receive surgical treatment during the trial period.
• With a history of severe food or drug allergies.
• Diagnosed with digestive system organic lesions such as gastrointestinal ulcers and bleeding.
• Suffering from severe physical and mental illnesses under treatment, severe cardiovascular, cerebrovascular and hematological diseases, severe liver and kidney dysfunction, pulmonary infection or malignant tumors.

Full record on ClinicalTrials.gov

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