MenopauseNCT00799734
Chinese Medicine Therapy on Menopausal Symptoms
A study testing EXD in people with Menopause, run by The University of Hong Kong at 2 sites in China.
Trial summary
The objective of this study is to evaluate whether a Chinese medicine formula (Erxian Decoction，EXD) is effective in alleviating menopausal symptoms, improving sex hormone profile and bone turn-over. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- EXD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2009to Jun 2011
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese women aged 45 to 55 years old
- having irregular menstrual cycles (≥3 months) indicating perimenopausal status or with cessation of menstrual period for at least three months within the previous 12 months
- Total scores of Menopause Rating Scale≥28 indicating the menopausal symptoms are moderate or severe
- Not having used HRT or Chinese Medicine for at least 3 months prior to entry into the study
- Willing to give informed ,written consent to participate in the clinical study
Who cannot join
- Taking hormones or medications, which could affect the vasomotoric symptoms
- Having chronic illness, such as gastrointestinal, renal or liver disease, diabetes mellitus requiring treatment, uncontrolled hypertension
- Having serious diseases, such as cancer, autoimmune system diseases, thrombosis and thrombophlebitis
- Consuming alcohol, or taking psychiatric or psychotherapeutic drugs
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Obstetrics and Gynecology, the University of Hong Kong
Hong Kong, Hksar
Chinese Medicine Clinic cum Training and Research Centers of the University of Hong Kong
Hong Kong, Hong Kong
About this study
Official title: A Double-blind Randomized Placebo-controlled Clinical Trial on the Effects of Chinese Medicine Formula (Erxian Decoction) on Menopausal Symptoms
The objective of this study is to evaluate whether a Chinese medicine formula (Erxian Decoction，EXD) is effective in alleviating menopausal symptoms, improving sex hormone profile and bone turn-over.
Read the detailed description
This is a double-blind randomized placebo-controlled clinical trial to evaluate whether a Chinese medicine formula (Erxian Decoction) is effective in alleviating menopausal symptoms. This study will be conducted in Queen Mary Hospital and Chinese Medicine Clinic cum Training and Research Centers of the University of Hong Kong (Sassoon Road and Central). Women will be recruited from the general population by advertisements and promotion through media coverage.108 Chinese women with menopausal symptoms will be recruited and randomized into two groups.One is treatment group with 12 weeks of Erxian Decoction (well-controlled granules), the other is controlled group with 12 weeks of placebo. The treatment outcome measures include: 1) the severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes plus night sweats),the Menopause-Specific Quality of Life (MENQOL) Questionnaire and the Menopause Rating Scale(MRS). 2)biochemical indices:serum follicle-stimulating hormone(FSH),luteinizing hormone(LH),estradiol, progesterone levels. 3)safety indices: blood count,liver and renal function tests. All measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms and MENQOL Questionnaire, MRS. We expect this research will provide an effective and low-cost therapy for menopausal symptoms.
- Conditions
- Menopause
- Being tested
- EXD
- Keywords
- hot flushes, night sweats, menopausal symptoms, osteoporosis, complementary and alternative medicine
- Medical subject headings
- Hot Flashes, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXDDrug
Also called Er-xian Decoction (Prod. Code:3PP3082-3083)
Interventions: Intake of prepacked Chinese herbal medicine therapy (EXD), one sachet of granules (15g extracted granules) twice a day and placebo therapy of 15g granules with similar colour and taste.
| Study group | Role | What they receive |
|---|---|---|
| alternative medicine | Active comparator | Intake of prepacked Chinese herbal medicine (EXD), one sachet of granules (15g extracted granules) twice a day Receives: Drug: EXD |
| placebo | Placebo comparator | placebo therapy of 15g granules with similar colour and taste. Receives: Drug: EXD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes plus night sweats),the Menopause-Specific Quality of Life (MENQOL) Questionnaire and the Menopause Rating Scale(MRS).
Measured: every four weeks
Secondary outcomes (2)
bone markers (N-MID osteocalcin and serum crosslaps)
Measured: 12 weeks
Serum follicle-stimulating hormone (FSH), luteinizing hormone(LH), estradiol, progesterone levels
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Yao Tong, PhD, Principal investigator, School of Chinese Medicine, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799734
- Sponsor's protocol ID
- HKCTR-740
- Status last verified
- Jul 2011
- First submitted
- 28 Nov 2008
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Placebo-controlled Clinical Trial on the Effects of Chinese Medicine Formula (Erxian Decoction) on Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT00799734
- Acronym / sponsor ID
- HKCTR-740
- Conditions
- Menopause
- Keywords
- hot flushes, night sweats, menopausal symptoms, osteoporosis, complementary and alternative medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Dec 2008 (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 objective of this study is to evaluate whether a Chinese medicine formula (Erxian Decoction，EXD) is effective in alleviating menopausal symptoms, improving sex hormone profile and bone turn-over.
Detailed description
This is a double-blind randomized placebo-controlled clinical trial to evaluate whether a Chinese medicine formula (Erxian Decoction) is effective in alleviating menopausal symptoms. This study will be conducted in Queen Mary Hospital and Chinese Medicine Clinic cum Training and Research Centers of the University of Hong Kong (Sassoon Road and Central). Women will be recruited from the general population by advertisements and promotion through media coverage.108 Chinese women with menopausal symptoms will be recruited and randomized into two groups.One is treatment group with 12 weeks of Erxian Decoction (well-controlled granules), the other is controlled group with 12 weeks of placebo. The treatment outcome measures include: 1) the severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes plus night sweats),the Menopause-Specific Quality of Life (MENQOL) Questionnaire and the Menopause Rating Scale(MRS). 2)biochemical indices:serum follicle-stimulating hormone(FSH),luteinizing hormone(LH),estradiol, progesterone levels. 3)safety indices: blood count,liver and renal function tests. All measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms and MENQOL Questionnaire, MRS. We expect this research will provide an effective and low-cost therapy for menopausal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alternative medicine | Active comparator | Drug: EXDIntake of prepacked Chinese herbal medicine (EXD), one sachet of granules (15g extracted granules) twice a day |
| placebo | Placebo comparator | Drug: EXDplacebo therapy of 15g granules with similar colour and taste. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese women aged 45 to 55 years old
- having irregular menstrual cycles (≥3 months) indicating perimenopausal status or with cessation of menstrual period for at least three months within the previous 12 months
- Total scores of Menopause Rating Scale≥28 indicating the menopausal symptoms are moderate or severe
- Not having used HRT or Chinese Medicine for at least 3 months prior to entry into the study
- Willing to give informed ,written consent to participate in the clinical study
Key exclusion criteria (4 listed)
- Taking hormones or medications, which could affect the vasomotoric symptoms
- Having chronic illness, such as gastrointestinal, renal or liver disease, diabetes mellitus requiring treatment, uncontrolled hypertension
- Having serious diseases, such as cancer, autoimmune system diseases, thrombosis and thrombophlebitis
- Consuming alcohol, or taking psychiatric or psychotherapeutic drugs
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 |
|---|---|---|
| EXDAlso: Er-xian Decoction (Prod. Code:3PP3082-3083)Interventions: Intake of prepacked Chinese herbal medicine therapy (EXD), one sachet of granules (15g extracted granules) twice a day and placebo therapy of 15g granules with similar colour and taste. | Drug | alternative medicine, placebo |
Primary outcome
The severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes plus night sweats),the Menopause-Specific Quality of Life (MENQOL) Questionnaire and the Menopause Rating Scale(MRS).
Time frame: every four weeks
2 secondary outcomes
bone markers (N-MID osteocalcin and serum crosslaps)
Time frame: 12 weeks
Serum follicle-stimulating hormone (FSH), luteinizing hormone(LH), estradiol, progesterone levels
Time frame: 12 weeks
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 26 Jul 2011.
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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.
Yao Tong, PhD principal investigator
School of Chinese Medicine, HKU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXD in people with Menopause, run by The University of Hong Kong at 2 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 5 inclusion and 4 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 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
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?
The severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes plus night sweats),the Menopause-Specific Quality of Life (MENQOL) Questionnaire and the Menopause Rating Scale(MRS). (time frame: every four weeks). 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 26 Jul 2011.