Clinical trial
The Effect of Valerian on Insomnia in Menopausal Women: Randomized Placebo-controlled Trial
Name
2021MenoVal / CMUH109-REC2-177
Description
Menopausal women often complain that it is difficult to fall asleep and easy to wake up at night and early in the morning and it is in the middle of night difficult to fall asleep again. If the above symptoms persist for at least three months and occur at least three times a week, plus the impact on daytime work and rest, and meet the International Classification of Sleep Disorders (ICSD-3) )'S s "Insomnia" diagnostic criteria. According to statistics, 30% to 60% of women face sleep disorders during menopause.
Trial arms
Trial start
2021-12-14
Estimated PCD
2025-01-20
Trial end
2025-01-20
Status
Recruiting
Treatment
Valerian
A natural plant
Arms:
Control, Valerian
Size
100
Primary endpoint
Sleep quallity
30 days
Eligibility criteria
Inclusion Criteria:
1. 45〜60 years old, and is menopaused for at least 1 year。
2. meet the criteria of ICSD-3 for insomnia
3. PSQI \> 5
Exclusion Criteria:
1. psychiatry disease
2. Heart, brain, liver diseases
3. Insomnia is caused by diseases.
4. Steroid used within 6 months
5. pregnant or breastfeeding
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-04-08
1 organization
1 product
2 indications
Organization
China Medical University HospitalProduct
ValerianIndication
MenopauseIndication
Insomnia