Pharmacokinetics Study of Qing'E Pill

Shanghai University of Traditional Chinese Medicine

Status and phase: Completed; Phase 1

Conditions: Menopause

Treatments: Drug: Qing'E pill

Study type: Interventional

Funder types: Other

Identifiers

NCT01931436

QE-2458-2

Details and patient eligibility

About

This study will investigate the pharmacokinetics of single and multiple doses of Qing'E pills in Chinese menopause volunteers. The main components of Qing'E pill into the blood such as psoralen and Isopsoralen will be detected.

Enrollment: 24 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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. The score of Kupperman index is not less than 15.
4. Patients unused estrogen tablets or progesterone injection in 6 months.
5. Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
6. Get subjects informed consent process should comply with GCP requirements.

Exclusion criteria

1. There is no clinical significance abnormal in physical and laboratory examination.
2. Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
3. Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g/L).
4. 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.
5. Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
6. People with allergies.
7. People taking other drugs within 14 days before the trail.
8. Patients are participating in other clinical trials within 3 months.
9. Pregnant Women.
10. Alcoholics or smokers (past or smoking).

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Qing'E pill

Experimental group

Description:

Administered twice a day, and each 9 g

Treatment:

Drug: Qing'E pill