Climacteric SymptomsNCT00275964
Development of Active Safety Surveillance System for Traditional Chinese Medicine
An observational study of Climacteric Symptoms and Hot Flushes and/or Sweats, run by National Taiwan University Hospital.
Trial summary
Context:Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have attracted people's focus on the alternative therapy for menopausal symptoms. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Climacteric Symptoms, Hot Flushes and/or Sweats
- What is being tested?
- TMN-1
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2004to Sep 2004
- 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 45 to 55 years
- Women only
- Adult
Who may be able to join
- women between age of 45 and 55 and suffered from hot flushes and/or sweats
- had not participated in any trial within the previous 3 months before beginning this study
- were willing to participate in the trial and give written informed consent
Who cannot join
- had received any form of hormonal therapy within 3 months prior to the study
- had been diagnosed with any form of cancer and under treatment
- were afflicted with abnormal uterine bleeding and unknown etiology
- had hypertension or diabetes mellitus and were under treatment for these conditions
- had any abnormal finding for kidney, liver, or thyroid functions
- were currently taking antidepressants, alpha or beta-blocking agent, e.g., clomidine, ergot, ergot derivatives, or anti-estrogen medications such as tamoxifen and/or herbal hormones (isoflavon
- were suffering from arrhythmia or any other form of heart disease.
About this study
Context:Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have attracted people's focus on the alternative therapy for menopausal symptoms. This study drug- a mixture of CHIA-WEI-HSIAO-YAO-SAN, CHIH-PO-TI-HUANG-WAN, HSIANG-SHA-LIU-CHUN-TZU-TANG (TMN1) is widely used as an alternative to hormonal therapies for hot flush in Taiwan. However, there is a paucity of data supporting their efficacy and safety.
Objective:To evaluate the safety and efficacy of TMN1 in the treatment of hot flush.
Read more
Design and Setting:A multi-center, prospective, observational follow-up study was conducted from July 2003 to December 2004 in 4 hospitals.
Participants:In total, 136 eligible subjects entered this study. They were required to take study drug 3 times a day for 12 weeks and make 9 visits at scheduled time for follow up efficacy and safety evaluations.
Main Outcome Measures:During the observation period, the investigators and study nurses actively enquired subjects if there was any adverse event (AEs) occurring to them by using Traditional Chinese medicine Adverse Events (TCM AE) questionnaire which includes 20 AEs proposed by experienced CM doctors as most commonly seen in the use of study drug. Every subject's complaint or abnormal laboratory value were carefully examined for possible causality and reviewed and decided by the research team. The primary outcome measure was the mean changes from baseline to week 12 in terms of frequency of hot flush and the severity of menopausal symptoms measured by the Kupperman Menopause Index. The secondary outcome measures included changes in quality of life measured by World Health Organization Quality of Life (WHOQOL) questionnaire, and adverse events monitored actively by a global assessment of tolerability. During the study period, every subject also received tests on routine hematology, biochemical function, and gynecologically relevant hormones at baseline visit, 4 weeks and 12 weeks after medication.
- Conditions
- Climacteric Symptoms, Hot Flushes and/or Sweats
- Being tested
- TMN-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMN-1Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startFeb 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Climacteric SymptomsStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health
- Investigators
- Jung Der Wang, M.D., Sc.D.,, Study director, Institute of Occupational Medicine and Industrial Hygiene, National Taiwan University College of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275964
- Sponsor's protocol ID
- 920807
- Status last verified
- Jun 2005
- First submitted
- 11 Jan 2006
- Last updated
- 24 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Active Safety Surveillance System for Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT00275964
- Acronym / sponsor ID
- 920807
- Conditions
- Climacteric Symptoms, Hot Flushes and/or Sweats
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Department of Health
- Study start
- Feb 2004
- Study completion
- Sep 2004
- First posted
- 12 Jan 2006 (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.
Context:Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have attracted people's focus on the alternative therapy for menopausal symptoms. This study drug- a mixture of CHIA-WEI-HSIAO-YAO-SAN, CHIH-PO-TI-HUANG-WAN, HSIANG-SHA-LIU-CHUN-TZU-TANG (TMN1) is widely used as an alternative to hormonal therapies for hot flush in Taiwan. However, there is a paucity of data supporting their efficacy and safety.
Objective:To evaluate the safety and efficacy of TMN1 in the treatment of hot flush.
Design and Setting:A multi-center, prospective, observational follow-up study was conducted from July 2003 to December 2004 in 4 hospitals.
Participants:In total, 136 eligible subjects entered this study. They were required to take study drug 3 times a day for 12 weeks and make 9 visits at scheduled time for follow up efficacy and safety evaluations.
Main Outcome Measures:During the observation period, the investigators and study nurses actively enquired subjects if there was any adverse event (AEs) occurring to them by using Traditional Chinese medicine Adverse Events (TCM AE) questionnaire which includes 20 AEs proposed by experienced CM doctors as most commonly seen in the use of study drug. Every subject's complaint or abnormal laboratory value were carefully examined for possible causality and reviewed and decided by the research team. The primary outcome measure was the mean changes from baseline to week 12 in terms of frequency of hot flush and the severity of menopausal symptoms measured by the Kupperman Menopause Index. The secondary outcome measures included changes in quality of life measured by World Health Organization Quality of Life (WHOQOL) questionnaire, and adverse events monitored actively by a global assessment of tolerability. During the study period, every subject also received tests on routine hematology, biochemical function, and gynecologically relevant hormones at baseline visit, 4 weeks and 12 weeks after medication.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women between age of 45 and 55 and suffered from hot flushes and/or sweats
- had not participated in any trial within the previous 3 months before beginning this study
- were willing to participate in the trial and give written informed consent
Key exclusion criteria (7 listed)
- had received any form of hormonal therapy within 3 months prior to the study
- had been diagnosed with any form of cancer and under treatment
- were afflicted with abnormal uterine bleeding and unknown etiology
- had hypertension or diabetes mellitus and were under treatment for these conditions
- had any abnormal finding for kidney, liver, or thyroid functions
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 |
|---|---|---|
| TMN-1 | Drug | – |
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 24 Oct 2008.
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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.
Jung Der Wang, M.D., Sc.D., study director
Institute of Occupational Medicine and Industrial Hygiene, National Taiwan University College of Public Health
Questions about this trial
What is this clinical trial studying?
An observational study of Climacteric Symptoms and Hot Flushes and/or Sweats, run by National Taiwan University Hospital.
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 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
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 24 Oct 2008.