Qing'E Formula Therapy on Menopausal Symptoms

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is effective in alleviating menopausal symptoms and safety.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Longhua Hospital; Shanghai Municipal Hospital of Traditional Chinese Medicine; Shanghai Putuo District Center Hospital; Shanghai Yueyang Integrated Medicine Hospital

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.