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A Randomized Controlled Trial of Ergothioneine on Sleep Quality and Skin Status in Healthy Adults

A Randomized Controlled Trial of Ergothioneine on Sleep Quality and Skin Status in Healthy Adults

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600132314
Enrollment
Unknown
Registered
2026-09-11
Start date
2026-12-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Mild decline in sleep quality and declined skin physiological function

Interventions

Test product Group 2:Ergothioneine Capsules (60 mg)
Test Article Group 1:Ergothioneine Capsules (20 mg)

Sponsors

The First People's Hospital of Kunshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Healthy adults aged 20 to 55 years inclusive, of all genders; 2. Self-perceived sleep disturbance or deteriorated skin condition; 3. They fully understand the research objectives and trial procedures and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Receiving ongoing treatment for sleep disorders; 2. Pittsburgh Sleep Quality Index (PSQI) score > 8, or Skin Quality Scale (SQS) score >= 19; 3. Engaged in night-shift work and planning to alter regular sleep schedules; 4. Routine intake of antioxidant medicines, health foods and nutritional supplements (such as VC, VE, tea polyphenols, etc.); 5. Daily mushroom intake > 100 grams per day; 6. Average habitual alcohol intake > 60 grams per day within the past 3 months; 7. Patients suffering from severe cardiovascular, endocrine or urinary system diseases; 8. Being pregnant or breastfeeding at present or planning to become pregnant during the trial; 9. Those with known allergies to any ingredient of the test product; 10. Those participating in or planning to join other clinical trials; 11. Other conditions where the investigator judges poor compliance or unsuitability for participation in this study.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI) score;Skin physicochemical indicators (skin firmness and elasticity);

Secondary

MeasureTime frame
Adverse Events (AEs) and Serious Adverse Events (SAEs);Objective monitoring by sleep-tracking wristband;Serum hormone levels (cortisol, melatonin);Skin Quality Scale (SQS) score;Oxidative stress indicators (SOD, MDA, GSH);Inflammatory factors (IL-6, TNF-a);Skin physicochemical indicators;Dietary Questionnaire;

Countries

China

Contacts

Public ContactChen Yafang

The First People's Hospital of Kunshan

yafang01@126.com+86 512 57568516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026