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Clinical evidence for melatonin-rich milk to improve sleep

Clinical evidence for melatonin-rich milk to improve sleep

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070906
Enrollment
Unknown
Registered
2023-04-26
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Interventions

Experimental group:Rich in melatonin milk
Control group:Regular milk

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) It conforms to the diagnostic criteria of chronic insomnia in Chinese Adult Insomnia Diagnosis and Treatment Guidelines (2017 Edition) [25] (Annex 5);2) PSQI scale (Annex 3) score =7 points or ISI scale > 7 points 3) no allergy or intolerance to melatonin milk;4) Volunteer for the experiment.

Exclusion criteria

Exclusion criteria: 1) Patients with malignant tumors, severe heart, liver, renal insufficiency, autoimmune diseases, blood system diseases and other systemic conditions.2) Patients with diseases of nervous system, cardiovascular system, respiratory system, digestive system and endocrine system, physical diseases (itchy skin and chronic pain, etc.).3) Patients with dementia and sensory aphasia due to various reasons who could not cooperate with the study.4) Patients with severe anxiety, depression, mania, schizophrenia and suicidal tendencies.5) Patients who are bedridden for a long time or have serious decline in daily living ability and cannot take care of themselves.6) Patients who are participating in other clinical trials.7) Patients in pregnancy or lactation period.8) Patients with an unnatural lifestyle (such as shift workers and individuals with jet lag);

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;Severity of insomnia;

Secondary

MeasureTime frame
Urinary metabolome;Serum metabolome;Intestinal flora;Salivary melatonin;

Countries

China

Contacts

Public ContactPeng Dantao

China-Japan Friendship Hospital

pengdantao2000@163.com+86 13910908579

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026