Menopause
Conditions
Keywords
menopausal syndrome, climacteric syndrome, Hot flashes, Sweat
Brief summary
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.
Interventions
DRUGQing'E pills
composed of eucommia, psoralen, walnuts and garlic
DRUGPlacebo
Containing 2% of Qing'E pills
Sponsors
Longhua Hospital
Shanghai Yueyang Integrated Medicine Hospital
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai Putuo District Center Hospital
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months. 2. Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours. 3. Patients unused estrogen tablets or progesterone injection in 6 months. 4. Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months. 5. Get subjects informed consent process should comply with GCP requirements.
Exclusion criteria
1. Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g / L). 2. Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer. 3. Allergic constitution and known allergy to the drug. 4. Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill. 5. 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. 6. Alcoholics or smokers (past or smoking). 7. Patients are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hot flushes | 12 weeks | Change in frequency of hot flushes from baseline to week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hot flushes | 4 weeks, 8 weeks | Change in frequency of hot flushes from baseline to week 4 and week 8. |
| Mean differences of Kupperman index | 4 weeks, 8 weeks and 12 weeks | 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) |
| Mean difference of single clinical symptom in Kupperman index | 12 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nerve-endocrine-immune (NEI） network profile | 12 weeks | To evaluate the difference of NEI network expression from baseline to 12 weeks. The indices in NEI network include: Hypothalamic-pituitary-adrenal axis: CRH, ATCH, CORT; Hypothalamic-pituitary-thyroid axis: TRH, T3, T4; Renin - angiotensin - aldosterone system: PRA, Ang2, ALD; Sex hormones: E2, FSH; Immune factors: TNF-α、IL-6、IL-1; Cardiovascular indicators: ET, NO, Hcy, Folic acid |
| Urine metabolomics | 4 weeks, 8 weeks and 12 weeks | — |
Countries
China
Outcome results
None listed