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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01931436
First Posted: August 29, 2013
Last Update Posted: August 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wuxi People's Hospital
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
  Purpose
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
Menopause Drug: Qing'E pill Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931436


Contacts
Contact: Zheng Qingshan, MD +86-021-51322556 zheng.zqs@gmail.com

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

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01931436     History of Changes
Other Study ID Numbers: QE-2458-2
First Submitted: August 8, 2013
First Posted: August 29, 2013
Last Update Posted: August 29, 2013
Last Verified: August 2013

Keywords provided by Shanghai University of Traditional Chinese Medicine:
Menopause, pharmacokinetic