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NCT Number: NCT01931436

Pharmacokinetics Study of Qing'E Pill

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.

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Key information

Conditions

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 210038, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months.
  • Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours.
  • The score of Kupperman index is not less than 15.
  • Patients unused estrogen tablets or progesterone injection in 6 months.
  • Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
  • Get subjects informed consent process should comply with GCP requirements.

Exclusion criteria

  • There is no clinical significance abnormal in physical and laboratory examination.
  • Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
  • Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g/L).
  • 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.
  • Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
  • People with allergies.
  • People taking other drugs within 14 days before the trail.
  • Patients are participating in other clinical trials within 3 months.
  • Pregnant Women.
  • Alcoholics or smokers (past or smoking).

Treatment and study plan

Qing'E pill

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Wuxi People's Hospital

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 29, 2013
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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