Clinical trial NCT01805765: Qing'E Formula Therapy on Menopausal Symptoms
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial on the Effects of Chinese Medicine Formula (Qing'E) on Menopausal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Menopause
Keywords: menopausal syndrome
climacteric syndrome
Hot flashes
Sweat
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Longhua Hospital
name: Shanghai Yueyang Integrated Medicine Hospital
name: Shanghai Municipal Hospital of Traditional Chinese Medicine
name: Shanghai Putuo District Center Hospital
First posted: 2013-03-06
Enrollment: 240
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hot flushes
timeFrame: 12 weeks
Secondary outcomes:
measure: Hot flushes
timeFrame: 4 weeks, 8 weeks
measure: Hot flushes
timeFrame: 4 weeks, 8 weeks and 12 weeks
measure: Mean differences of Kupperman index
timeFrame: 4 weeks, 8 weeks and 12 weeks
measure: Mean difference of single clinical symptom in Kupperman index
timeFrame: 12 weeks
Other outcomes:
measure: Nerve-endocrine-immune (NEI） network profile
timeFrame: 12 weeks
measure: Urine metabolomics
timeFrame: 4 weeks, 8 weeks and 12 weeks
Locations:
city: Shanghai
country: China
facility: Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Universitu of TCM
name: Qingshan Zheng, Doctor
role: STUDY_CHAIR
References: