Pharmacokinetics Study of Qing'E Pill

A Single-site, Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics of the Main Components of Qing'E Pill (a Chinese Medicine Formula) Into the Blood in Chinese Menopausal Women

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01931436

Enrollment

Registered

2013-08-29

Start date

2013-08-31

Completion date

2014-04-30

Last updated

2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

Menopause, pharmacokinetic

Brief summary

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.

Interventions

DRUGQing'E pill

Qing'E pill is composed of eucommia, psoralen, walnuts and garlic.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 60 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic parameters of the main components of Qing'E pill (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))	Up to 48 hours postdose for each period	To detect the main components of Qing'E pill into the blood such as psoralen and Isopsoralen.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026