MenopausePhase 2/3NCT01805765
Qing'E Formula Therapy on Menopausal Symptoms
A Phase 2/3 study testing Qing'E pills in people with Menopause, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is effective in alleviating menopausal symptoms and safety. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Qing'E pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Oct 2014
- Phase
- Phase 2/3
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months.
- Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours.
- Patients unused estrogen tablets or progesterone injection in 6 months.
- Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
- Get subjects informed consent process should comply with GCP requirements.
Who cannot join
- Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g / L).
- Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
- Allergic constitution and known allergy to the drug.
- Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
- Patients with hyperthyroidism, coronary atheroma, diabetes, obesity (body mass index of more than 30 kg/m2), migraine, malignant tumors, thromboembolic disease, gastrointestinal diseases affect absorption or autoimmune diseases.
- Alcoholics or smokers (past or smoking).
- Patients are participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 201108
About this study
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial on the Effects of Chinese Medicine Formula (Qing'E) on Menopausal Symptoms
The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is effective in alleviating menopausal symptoms and safety.
Read the detailed description
This is a double-blind placebo-controlled randomized clinical trial to evaluate whether a Chinese medicine formula (Qing'E, composed of eucommia, psoralen, walnuts and garlic) is effective in alleviating menopausal symptoms. 240 Chinese women with menopausal symptoms will be recruited and randomized into two groups. One is treatment group with 12 weeks of Qing'E pills (well-controlled), 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), the Kupperman index. 2) NEI network indices. 3) Urine metabolomics. All measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms, Kupperman index and urine metabolomics. Tyhe investigators expect this research will provide an effective and safe therapy for menopausal symptoms.
- Conditions
- Menopause
- Being tested
- Qing'E pills, Placebo
- Keywords
- menopausal syndrome, climacteric syndrome, Hot flashes, Sweat
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qing'E pillsDrug
composed of eucommia, psoralen, walnuts and garlic
PlaceboDrug
Containing 2% of Qing'E pills
| Study group | Role | What they receive |
|---|---|---|
| Qing'E pills | Active comparator | 9 g pills,twice a day for 12 weeks Receives: Drug: Qing'E pills |
| Placebo | Placebo comparator | 9 g pills,twice a day for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot flushes
Change in frequency of hot flushes from baseline to week 12.
Measured: 12 weeks
Secondary outcomes (4)
Hot flushes
Change in frequency of hot flushes from baseline to week 4 and week 8.
Measured: 4 weeks, 8 weeks
Hot flushes
Decline rate of hot flushes from baseline to week 4, week 8 and week 12;
Measured: 4 weeks, 8 weeks and 12 weeks
Mean differences of Kupperman index
To calculate the Kupperman index, the symptoms were weighted as follows: hot flashes (4), insomnia (2), nervousness (2), and all other symptoms (night sweats, depressed mood (melancholy), dizziness, tiredness, joint and muscular pain, headache, and palpitations (1). The highest potential score is thus 51. The score of hot flashes was based on number of complaints per day: slight (more than 5), moderate (5-10), and severe (more than 10)
Measured: 4 weeks, 8 weeks and 12 weeks
Mean difference of single clinical symptom in Kupperman index
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 posted6 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2014
- Study completionOct 2014
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Longhua Hospital, Shanghai Yueyang Integrated Medicine Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Putuo District Center Hospital
- Responsible party
- Sponsor
- Investigators
- Qingshan Zheng, Doctor, Study chair, Shanghai Universitu of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805765
- Sponsor's protocol ID
- QE-2458-1
- Other IDs
- SHU-5366432
- Status last verified
- Mar 2013
- First submitted
- 26 Feb 2013
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial on the Effects of Chinese Medicine Formula (Qing'E) on Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT01805765
- Acronym / sponsor ID
- QE-2458-1
- Conditions
- Menopause
- Keywords
- menopausal syndrome, climacteric syndrome, Hot flashes, Sweat
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Longhua Hospital, Shanghai Yueyang Integrated Medicine Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Putuo District Center Hospital
- Study start
- Mar 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Mar 2013 (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 (Qing'E) is effective in alleviating menopausal symptoms and safety.
Detailed description
This is a double-blind placebo-controlled randomized clinical trial to evaluate whether a Chinese medicine formula (Qing'E, composed of eucommia, psoralen, walnuts and garlic) is effective in alleviating menopausal symptoms. 240 Chinese women with menopausal symptoms will be recruited and randomized into two groups. One is treatment group with 12 weeks of Qing'E pills (well-controlled), 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), the Kupperman index. 2) NEI network indices. 3) Urine metabolomics. All measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms, Kupperman index and urine metabolomics. Tyhe investigators expect this research will provide an effective and safe therapy for menopausal symptoms.
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 |
|---|---|---|
| Qing'E pills | Active comparator | Drug: Qing'E pills9 g pills,twice a day for 12 weeks |
| Placebo | Placebo comparator | Drug: Placebo9 g pills,twice a day for 12 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months.
- Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours.
- Patients unused estrogen tablets or progesterone injection in 6 months.
- Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
- Get subjects informed consent process should comply with GCP requirements.
Key exclusion criteria (7 listed)
- Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g / L).
- Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
- Allergic constitution and known allergy to the drug.
- Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
- Patients with hyperthyroidism, coronary atheroma, diabetes, obesity (body mass index of more than 30 kg/m2), migraine, malignant tumors, thromboembolic disease, gastrointestinal diseases affect absorption or autoimmune diseases.
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 |
|---|---|---|
| Qing'E pillscomposed of eucommia, psoralen, walnuts and garlic | Drug | Qing'E pills |
| PlaceboContaining 2% of Qing'E pills | Drug | Placebo |
Primary outcome
Hot flushes
Time frame: 12 weeks
Change in frequency of hot flushes from baseline to week 12.
4 secondary outcomes
Hot flushes
Time frame: 4 weeks, 8 weeks
Hot flushes
Time frame: 4 weeks, 8 weeks and 12 weeks
Mean differences of Kupperman index
Time frame: 4 weeks, 8 weeks and 12 weeks
Mean difference of single clinical symptom in Kupperman index
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 5 Apr 2019.
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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.
Qingshan Zheng, Doctor study chair
Shanghai Universitu of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Qing'E pills in people with Menopause, run by Shanghai University of Traditional Chinese Medicine at 1 site 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 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 5 Apr 2019. 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Hot flushes (time frame: 12 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 5 Apr 2019.