Pharmacokinetics Study of Qing'E Pill

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931436
• Other study ID #: QE-2458-2
• Status: Completed
• Phase: Phase 1
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2022
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Menopause

Intervention

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

Locations

Country	Name	City	State
China	Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Wuxi People's Hospital

Country where clinical trial is conducted

China, 

Outcome

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