Menopausal and Female Climacteric StatesNCT01267539
Suan Tsao Jen Tang for Treating Menopause With Sleep Problem: a Clinical Observation
An observational study of Menopausal and Female Climacteric States, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City Hospital.Climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice daily for four weeks. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Menopausal and Female Climacteric States
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2008to Apr 2010
- Phase
- Observational
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: The subjects enrolled in the study were climacteric women, ranging from 40-65 years of age, with a Pittsburg Sleep Quality Index (PSQI) of greater than six. These women spent 45 minutes or more falling asleep, slept less than six hours, and had struggled with this issue continuously for at least one month.
Who may be able to join
- Climacteric women, ranging from 40-65 years of age
- Pittsburg Sleep Quality Index (PSQI) of greater than six
- Falling asleep more than 45 minutes or slept less than six hours
Who cannot join
- Within three months of the study there had been a major incident
- Working the nightshift
- Lack of time or timing conflicts
- Pychosis, severe depression, obstructive sleep apnea-hypopnea, cardiac arrhythmia, acute myocardial infarction, high blood pressure, diabetes, or cancer
- Currently taking pharmaceuticals that affect melatonin, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, or prostaglandins
- Inability to read and fill out the forms for the study
- Any evidence of renal or liver dysfunction as defined by a level of at least 1.5 times of the upper reference limit
Trial locations and contacts
1 site in 1 country.
About this study
A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City Hospital.Climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice daily for four weeks.
Read the detailed description
A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City Hospital between April 2008 and April 2010. Sixty-seven climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice daily for four weeks. Baseline scores were measured on the Pittsburg Sleep Quality Index (PSQI), followed by further measures at the end of weeks one and four. The World Health Organization Quality of Life (WHOQOL) assessment and the Menopause Rating Scale (MRS) were undertaken as secondary outcomes. Regression models were constructed to explore the score differences between the baseline and at weeks one and four by various determinants including age, body mass index (BMI), and severity of baseline menopausal symptoms. Among 99 surveyed patients, 67 and 61 were screened for intention to treat (ITT) and per-protocol population set analysis, respectively. Statistically significant reductions in the PSQI index scores evidenced on the fourth week.
- Conditions
- Menopausal and Female Climacteric States
- Keywords
- Suan Zao Ren Tang, climacteric, PSQI, WHOQOL-BREF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startApr 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal and Female Climacteric StatesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- Chinese Medical Association
- Investigators
- Jung-Nien Lai, PHD, Study chair, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267539
- Sponsor's protocol ID
- TCHIRB-970110-E
- Status last verified
- Jan 2008
- First submitted
- 20 Dec 2010
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suan Tsao Jen Tang for Treating Menopause With Sleep Problem: a Clinical Observation
- ClinicalTrials.gov ID
- NCT01267539
- Acronym / sponsor ID
- TCHIRB-970110-E
- Conditions
- Menopausal and Female Climacteric States
- Keywords
- Suan Zao Ren Tang, climacteric, PSQI, WHOQOL-BREF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- Chinese Medical Association
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 Dec 2010 (estimated)
- 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.
A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City Hospital.Climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice daily for four weeks.
Detailed description
A prospective follow-up study was carried out in the Yang Ming branch of the Taipei City Hospital between April 2008 and April 2010. Sixty-seven climacteric women with sleep difficulty received SZRT at a rate of 4.0 g, thrice daily for four weeks. Baseline scores were measured on the Pittsburg Sleep Quality Index (PSQI), followed by further measures at the end of weeks one and four. The World Health Organization Quality of Life (WHOQOL) assessment and the Menopause Rating Scale (MRS) were undertaken as secondary outcomes. Regression models were constructed to explore the score differences between the baseline and at weeks one and four by various determinants including age, body mass index (BMI), and severity of baseline menopausal symptoms. Among 99 surveyed patients, 67 and 61 were screened for intention to treat (ITT) and per-protocol population set analysis, respectively. Statistically significant reductions in the PSQI index scores evidenced on the fourth week.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The subjects enrolled in the study were climacteric women, ranging from 40-65 years of age, with a Pittsburg Sleep Quality Index (PSQI) of greater than six. These women spent 45 minutes or more falling asleep, slept less than six hours, and had struggled with this issue continuously for at least one month.
Key inclusion criteria (3 listed)
- Climacteric women, ranging from 40-65 years of age
- Pittsburg Sleep Quality Index (PSQI) of greater than six
- Falling asleep more than 45 minutes or slept less than six hours
Key exclusion criteria (7 listed)
- Within three months of the study there had been a major incident
- Working the nightshift
- Lack of time or timing conflicts
- Pychosis, severe depression, obstructive sleep apnea-hypopnea, cardiac arrhythmia, acute myocardial infarction, high blood pressure, diabetes, or cancer
- Currently taking pharmaceuticals that affect melatonin, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, or prostaglandins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
Related trials for Menopausal and Female Climacteric States
RecruitingPhase 1
A Study to Compare the Steady-State Bioavailability of Injectable Letrozole SIE and Oral Letrozole in Post-Menopausal Women With Hormone Receptor Positive Early Breast Cancer
Hormone Receptor Positive Early Breast Cancer
Recruiting
Evaluation of a Mobile Menopause Application
N95.1 Menopausal and Female Climacteric States
Not yet recruitingObservational study
An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States
Vasomotor Symptoms (VMS) Associated With Menopause
Not yet recruiting
Enhancing Mental and Physical Health of Women Veterans 3.0
Cardiovascular Diseases, Overweight
Enrolling by invitationObservational study
Vaginal Ecosystem and Network in the United States Study
Bacterial Vaginosis, Candidiasis
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.
Jung-Nien Lai, PHD study chair
Taipei City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopausal and Female Climacteric States, run by Taipei City 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 7 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: finished, as of the sponsor's last update on 28 Dec 2010. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 28 Dec 2010.