Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Pharmacokinetics Study of Qing'E Pill

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
Wuxi People's Hospital
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine Identifier:
First received: August 8, 2013
Last updated: August 26, 2013
Last verified: August 2013
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.

Condition Intervention Phase
Drug: Qing'E pill
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:

Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Pharmacokinetic parameters of the main components of Qing'E pill (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC)) [ Time Frame: 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.

Estimated Enrollment: 24
Study Start Date: August 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Qing'E pill
Administered twice a day, and each 9 g
Drug: Qing'E pill
Qing'E pill is composed of eucommia, psoralen, walnuts and garlic.


Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01931436

Contact: Zheng Qingshan, MD +86-021-51322556

China, Shanghai
Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 210038
Contact: Yang Jie, MD    +86-0510-85350351   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Wuxi People's Hospital
  More Information

Responsible Party: Shanghai University of Traditional Chinese Medicine Identifier: NCT01931436     History of Changes
Other Study ID Numbers: QE-2458-2
Study First Received: August 8, 2013
Last Updated: August 26, 2013

Keywords provided by Shanghai University of Traditional Chinese Medicine:
Menopause, pharmacokinetic processed this record on April 28, 2017