Menopausal WomenNCT05185219
The Effect of Valerian on Insomnia in Menopausal Women
A study testing Valerian in people with Menopausal Women and Insomnia, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Women, Insomnia
- What is being tested?
- Valerian
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Dec 2021to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 45〜60 years old, and is menopaused for at least 1 year。
- meet the criteria of ICSD-3 for insomnia
- PSQI > 5
Who cannot join
- psychiatry disease
- Heart, brain, liver diseases
- Insomnia is caused by diseases.
- Steroid used within 6 months
- pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University
Taichung
Su Shan-yu, 0975682032, shanyusu@gmail.com
Chen Xin-xi
About this study
Official title: The Effect of Valerian on Insomnia in Menopausal Women: Randomized Placebo-controlled Trial
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.
Read the detailed description
The investigators expect to receive outpatient admissions in the hospital attached to China Medical University. Menopausal women aged 45-60 years old who have been diagnosed with insomnia who meet criteria of International Classification of Sleep Disorders (ICSD-3) will be randomly assigned for clinical trials. Patients will take two Valerian capsules (1000mg/day) per day for four weeks. Pittsburgh Sleep Index (PSQI) will be used to evaluate subjective sleep quality. TCM patterns will be evaluated by three physicians of TCM gynecology independently before and after taking Valeriana. The data will conduct a biological analysis to compare the difference in sleep quality between the trial group and the control group.
- Conditions
- Menopausal Women, Insomnia
- Being tested
- Valerian
- Keywords
- menopause, insomnia, valerian
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValerianDrug
A natural plant
| Study group | Role | What they receive |
|---|---|---|
| Valerian | Experimental | generic name: XIE CAO CONC dosage form: capsule dosage: 500 mg/capsule, 6 capsules a day frequency: 3 times a day after each meal, 2 capsules each time duration: 30 days Receives: Drug: Valerian |
| Control | Placebo comparator | generic name: placebo (Caramel Colors dyed starch) dosage form: capsule dosage: 500 mg/capsule, 6 capsules a day frequency: 3 times a day after each meal, 2 capsules each time duration: 30 days Receives: Drug: Valerian |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quallity
Sleep quality will be evaluated by Pittsburgh Sleep Index (PSQI). The sum of the scores on PSQI ranges from 0 to 21, and higher scores mean a worse outcome.
Measured: 30 days
Secondary outcomes (1)
Traditional Chinese medicine (TCM) constitution
TCM constitution will be measured by three TCM doctor and TCM questionnaire
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start14 Dec 2021
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal WomenStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shan-Yu Su, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185219
- Sponsor's protocol ID
- 2021MenoVal / CMUH109-REC2-177
- Status last verified
- Apr 2024
- First submitted
- 3 Dec 2021
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Valerian on Insomnia in Menopausal Women: Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05185219
- Acronym / sponsor ID
- 2021MenoVal / CMUH109-REC2-177
- Conditions
- Menopausal Women, Insomnia
- Keywords
- menopause, insomnia, valerian
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators expect to receive outpatient admissions in the hospital attached to China Medical University. Menopausal women aged 45-60 years old who have been diagnosed with insomnia who meet criteria of International Classification of Sleep Disorders (ICSD-3) will be randomly assigned for clinical trials. Patients will take two Valerian capsules (1000mg/day) per day for four weeks. Pittsburgh Sleep Index (PSQI) will be used to evaluate subjective sleep quality. TCM patterns will be evaluated by three physicians of TCM gynecology independently before and after taking Valeriana. The data will conduct a biological analysis to compare the difference in sleep quality between the trial group and the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valerian | Experimental | Drug: Valeriangeneric name: XIE CAO CONC dosage form: capsule dosage: 500 mg/capsule, 6 capsules a day frequency: 3 times a day after each meal, 2 capsules each time duration: 30 days |
| Control | Placebo comparator | Drug: Valeriangeneric name: placebo (Caramel Colors dyed starch) dosage form: capsule dosage: 500 mg/capsule, 6 capsules a day frequency: 3 times a day after each meal, 2 capsules each time duration: 30 days |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 45〜60 years old, and is menopaused for at least 1 year。
- meet the criteria of ICSD-3 for insomnia
- PSQI > 5
Key exclusion criteria (5 listed)
- psychiatry disease
- Heart, brain, liver diseases
- Insomnia is caused by diseases.
- Steroid used within 6 months
- pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValerianA natural plant | Drug | Control, Valerian |
Primary outcome
Sleep quallity
Time frame: 30 days
Sleep quality will be evaluated by Pittsburgh Sleep Index (PSQI). The sum of the scores on PSQI ranges from 0 to 21, and higher scores mean a worse outcome.
1 secondary outcome
Traditional Chinese medicine (TCM) constitution
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valerian in people with Menopausal Women and Insomnia, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shan-Yu Su (0975682032, shanyusu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quallity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.