Pharmacokinetics Study of Qing'E Pill

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Shanghai University of Traditional Chinese Medicine
Sponsor:
Collaborator:
Wuxi People’s Hospital
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01931436
First received: August 8, 2013
Last updated: August 26, 2013
Last verified: August 2013
  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: Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years to 60 Years
Genders 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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01931436     History of Changes
Other Study ID Numbers: QE-2458-2
Study First Received: August 8, 2013
Last Updated: August 26, 2013
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014