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A pilot study of the influence of herbal tea (GS007) on sleep disturbance

A pilot study of the influence of herbal tea (GS007) on sleep disturbance: Single group, pre-and post-intervention study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006414
Enrollment
20
Registered
2021-08-03
Start date
2021-09-01
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

None listed

Interventions

Dietary Supplement : People who are assigned to drinking tea group drink the tea(GS007) two times a day on certain time for 4 weeks, and follow-up at 4 and 8 weeks after the end of intervention.

Sponsors

Semyung University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Men and women Less than 49 years old over 30 years old. ? Person who complained of sleep problems more than three times a week such as awakening at least 30 minutes until sleep, awakening at least 30 minutes until resleep after awake. ? Person who got Insomnia Severity Index(ISI) score more than 8 point and less than 21 point.

Exclusion criteria

Exclusion criteria: ? Person who received medical or korean medical treatment for sleep problems in recent one month. ? Person who is taking medication or receiving treatment for nervous system and psychiatric disorders in recent one month.(Depression, anxiety disorders, dementia etc.). ? Person who diagnosed with other diseases which can lead toinsomnia(Sleep apnea, narcolepsy, restless leg syndrome etc.). ? Person who was recently alcohol abuse / dependence within 6 months. ? Person who have night work, shift work. and severe duplication. ? Pregnant women, nursing mothers and people who are planning pregnancy within 6 months. ? Person who is taking medication that may affect the clinical studies, or clinical personnel has determined not appropriate person.

Design outcomes

Primary

MeasureTime frame
Change of Insomnia Severity Index(ISI) score

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index(PSQI), Cole-Hot, Short Form-12, Depression, Pulse wave, Heart rate variability, and blood test

Countries

Korea, Republic of

Contacts

Public ContactBaek Younghwa

Korea Institute of Oriental Medicine

aori79@kiom.re.kr+82-42-868-9286

Outcome results

None listed

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