Menopausal SyndromePhase 3NCT00933725
Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome
A Phase 3 study testing TCM intervention and Western intervention in people with Menopausal Syndrome, run by Guangzhou University of Traditional Chinese Medicine at 8 sites in China.
Trial summary
The purpose of this multiple-centered, randomized, controlled study is to investigate the efficacy and safety of a combination using herbs prescription and traditional Chinese medicine (TCM) emotion treatment in women with menopausal syndrome. Read more about this study
- Who is it for?
- Ages 41 to 60 years, women only
- Conditions the study is for
- Menopausal Syndrome
- What is being tested?
- TCM intervention and Western intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 8 sitesChina
- Study dates
- Aug 2009to Jun 2011
- Phase
- Phase 3
- 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 41 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 41-60;
- Amenorrhea for at least 6 months;
- Menstruation dysfunction or cessation because of age or bilateral ovariectomy;
- Hot flushes and night sweats symptoms;
- Vaginal secretion decreased with or without dyspareunia;
- Kupperman Index (KI) score ≥ 15;
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- Self-rating Anxiety Scale or Self-rating Depression Scale standard score >50,but <72(standard score= scale score ×1.25);
- FSH ≥ 20 IU/L;
- Thickness of endometrium ≤0.5cm if Amenorrhea for at least 12 months;or ≤1.5cm if Amenorrhea for 6 months to 12 months;
- Meet the diagnosis criteria of TCM syndrome of liver stagnation and kidney deficiency.
Who cannot join
- With malignant tumor in reproductive system;
- With benign tumor in reproductive system and need surgery;
- Malignant tumor in mammary gland;
- Irregular vaginal bleeding for unknown reasons;
- Thickness of endometrium ≥1.5cm by ultrasound examination;
- Have used Sex hormone medicine or joined other clinical trials 3 months before;
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- Allergy;
- Severe diseases (eg., of the cardiovascular, liver, kidney) or uncontrolled endocrine diseases (eg., diabetes mellitus, hyperthyreosis )
- Severe psychiatric disease diagnosed by psychiatric physician;
- Refuse informed consent.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
Foshan Hospital of Traditional Chinese Medicine
Foshan, Guangdong, 528000
Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Liwan Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510360
Longhua Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, 200032
Baokang Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, 300170
Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
Affiliated Hospital of Hubei College of Traditional Chinese Medicine
Wuhan, Hubei, 430061
About this study
Official title: Efficacy and Safety of Combined Treatment of Herbs and TCM Emotion Treatment for Women With Menopausal Syndrome: A Multiple-centered Randomized Controlled Trial
The purpose of this multiple-centered, randomized, controlled study is to investigate the efficacy and safety of a combination using herbs prescription and traditional Chinese medicine (TCM) emotion treatment in women with menopausal syndrome.
Read the detailed description
Menopausal syndrome is a high incident disease which is associated with great influence in women's health and quality of life. It involves physical discomforts and emotional symptoms. Traditional Chinese medicine (TCM) theory emphasizes treating physical and emotional symptoms simultaneously viewing one person as an entirety. Herbs prescription and TCM emotion treatment is effective and safe to treat women with menopausal syndrome in clinical practice.
- Conditions
- Menopausal Syndrome
- Being tested
- TCM intervention, Western intervention
- Keywords
- menopausal syndrome, TCM intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM interventionOther
Drug: Particle of compound Chinese herbs(produced by San_jiu Medical \& Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months.
One tablet placebo of Tibolone (provided by San_jiu Medical \& Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China, once every two days, taken orally, for two months.
Behavioral: TCM emotion treatment: made under the guide of TCM theory, administered by qualified TCM physician, for three times in two months.
Western interventionOther
Drug: Tibolone, (produced by Oujianong corporation, Nanjing, China), 2.5mg, once every two days, taken orally, for two months; Particle placebo of compound Chinese herbs (produced by San_jiu Medical \& Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months.
Behavioral: supportive psychotherapy, administered by qualified physician, for three times in two months.
| Study group | Role | What they receive |
|---|---|---|
| TCM intervention | Experimental | Particle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone Receives: Other: TCM intervention |
| Western intervention | Active comparator | Tibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs Receives: Other: Western intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kupperman index
Measured: 2 months
Secondary outcomes (1)
blood serum estradiol
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal SyndromeStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoyun Wang, Bachelor, Principal investigator, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933725
- Sponsor's protocol ID
- 2007BAI20B014
- Other IDs
- 2007BAI20B014
- Status last verified
- May 2010
- First submitted
- 2 Jul 2009
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combined Treatment of Herbs and TCM Emotion Treatment for Women With Menopausal Syndrome: A Multiple-centered Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00933725
- Acronym / sponsor ID
- 2007BAI20B014
- Conditions
- Menopausal Syndrome
- Keywords
- menopausal syndrome, TCM intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Jul 2009 (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.
The purpose of this multiple-centered, randomized, controlled study is to investigate the efficacy and safety of a combination using herbs prescription and traditional Chinese medicine (TCM) emotion treatment in women with menopausal syndrome.
Detailed description
Menopausal syndrome is a high incident disease which is associated with great influence in women's health and quality of life. It involves physical discomforts and emotional symptoms. Traditional Chinese medicine (TCM) theory emphasizes treating physical and emotional symptoms simultaneously viewing one person as an entirety. Herbs prescription and TCM emotion treatment is effective and safe to treat women with menopausal syndrome in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM intervention | Experimental | Other: TCM interventionParticle of compound Chinese herbs and TCM emotion treatment and tablet placebo of Tibolone |
| Western intervention | Active comparator | Other: Western interventionTibolone and supportive psychotherapy and Particle placebo of compound Chinese herbs |
Who may qualify
- Ages
- 41 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Aged 41-60;
- Amenorrhea for at least 6 months;
- Menstruation dysfunction or cessation because of age or bilateral ovariectomy;
- Hot flushes and night sweats symptoms;
- Vaginal secretion decreased with or without dyspareunia;
Key exclusion criteria (10 listed)
- With malignant tumor in reproductive system;
- With benign tumor in reproductive system and need surgery;
- Malignant tumor in mammary gland;
- Irregular vaginal bleeding for unknown reasons;
- Thickness of endometrium ≥1.5cm by ultrasound examination;
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 |
|---|---|---|
| TCM interventionDrug: Particle of compound Chinese herbs(produced by San_jiu Medical \& Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months. One tablet placebo of Tibolone (provided by San_jiu Medical \& Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China, once every two days, taken orally, for two months. Behavioral: TCM emotion treatment: made under the guide of TCM theory, administered by qualified TCM physician, for three times in two months. | Other | TCM intervention |
| Western interventionDrug: Tibolone, (produced by Oujianong corporation, Nanjing, China), 2.5mg, once every two days, taken orally, for two months; Particle placebo of compound Chinese herbs (produced by San_jiu Medical \& Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months. Behavioral: supportive psychotherapy, administered by qualified physician, for three times in two months. | Other | Western intervention |
Primary outcome
Kupperman index
Time frame: 2 months
1 secondary outcome
blood serum estradiol
Time frame: 2 months
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 18 Jun 2012.
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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.
Xiaoyun Wang, Bachelor principal investigator
Guangzhou University of Traditional Chinese Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TCM intervention and Western intervention in people with Menopausal Syndrome, run by Guangzhou University of Traditional Chinese Medicine at 8 sites in China.
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 10 inclusion and 10 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 18 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Kupperman index (time frame: 2 months). 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 18 Jun 2012.