Status:
COMPLETED
Qing'E Formula Therapy on Menopausal Symptoms
Lead Sponsor:
Shanghai University of Traditional Chinese Medicine
Collaborating Sponsors:
Longhua Hospital
Shanghai Yueyang Integrated Medicine Hospital
Conditions:
Menopause
Eligibility:
FEMALE
40-60 years
Phase:
PHASE2
PHASE3
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 alleviat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01805765
Start Date
March 1 2013
End Date
October 1 2014
Last Update
April 5 2019
Active Locations (1)
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1
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China, 201108