Qing'E Formula Therapy on Menopausal Symptoms

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Shanghai University of Traditional Chinese Medicine
Sponsor:
Collaborators:
Longhua Hospital
Shanghai Yueyang Hospital
Shanghai Traditional Chinese Medicine Hospital
Shanghai Putuo Hospital
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01805765
First received: February 26, 2013
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is effective in alleviating menopausal symptoms and safety.


Condition Intervention Phase
Menopause
Drug: Qing'E pills
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial on the Effects of Chinese Medicine Formula (Qing'E) on Menopausal Symptoms

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Hot flushes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in frequency of hot flushes from baseline to week 12.


Secondary Outcome Measures:
  • Hot flushes [ Time Frame: 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
    Change in frequency of hot flushes from baseline to week 4 and week 8.

  • Hot flushes [ Time Frame: 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Decline rate of hot flushes from baseline to week 4, week 8 and week 12;

  • Mean differences of Kupperman index [ Time Frame: 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
    To calculate the Kupperman index, the symptoms were weighted as follows: hot flashes (4), insomnia (2), nervousness (2), and all other symptoms (night sweats, depressed mood (melancholy), dizziness, tiredness, joint and muscular pain, headache, and palpitations (1). The highest potential score is thus 51. The score of hot flashes was based on number of complaints per day: slight (more than 5), moderate (5-10), and severe (more than 10)

  • Mean difference of single clinical symptom in Kupperman index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Nerve-endocrine-immune (NEI) network profile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    To evaluate the difference of NEI network expression from baseline to 12 weeks. The indices in NEI network include:

    Hypothalamic-pituitary-adrenal axis: CRH, ATCH, CORT; Hypothalamic-pituitary-thyroid axis: TRH, T3, T4; Renin - angiotensin - aldosterone system: PRA, Ang2, ALD; Sex hormones: E2, FSH; Immune factors: TNF-α、IL-6、IL-1; Cardiovascular indicators: ET, NO, Hcy, Folic acid


  • Urine metabolomics [ Time Frame: 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Qing'E pills
9 g pills,twice a day for 12 weeks
Drug: Qing'E pills
composed of eucommia, psoralen, walnuts and garlic
Placebo Comparator: Placebo
9 g pills,twice a day for 12 weeks
Drug: Placebo
Containing 2% of Qing'E pills

Detailed Description:

This is a double-blind placebo-controlled randomized clinical trial to evaluate whether a Chinese medicine formula (Qing'E, composed of eucommia, psoralen, walnuts and garlic) is effective in alleviating menopausal symptoms. 240 Chinese women with menopausal symptoms will be recruited and randomized into two groups. One is treatment group with 12 weeks of Qing'E pills (well-controlled), the other is controlled group with 12 weeks of placebo. The treatment outcome measures include: 1) the severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes), the Kupperman index. 2) NEI network indices. 3) Urine metabolomics. All measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms, Kupperman index and urine metabolomics. Tyhe investigators expect this research will provide an effective and safe therapy for menopausal symptoms.

  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. Patients unused estrogen tablets or progesterone injection in 6 months.
  4. Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
  5. Get subjects informed consent process should comply with GCP requirements.

Exclusion Criteria:

  1. Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g / L).
  2. Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
  3. Allergic constitution and known allergy to the drug.
  4. Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
  5. 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.
  6. Alcoholics or smokers (past or smoking).
  7. Patients are participating in other clinical trials.
  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: NCT01805765

Contacts
Contact: Zheng Qingshan, Doctor 86-021-51323006 zheng.zqs@gmail.com

Locations
China, Shanghai
Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 201108
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Longhua Hospital
Shanghai Yueyang Hospital
Shanghai Traditional Chinese Medicine Hospital
Shanghai Putuo Hospital
Investigators
Study Chair: Qingshan Zheng, Doctor Shanghai Universitu of TCM
  More Information

No publications provided

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01805765     History of Changes
Other Study ID Numbers: QE-2458-1, SHU-5366432
Study First Received: February 26, 2013
Last Updated: March 4, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai University of Traditional Chinese Medicine:
menopausal syndrome
climacteric syndrome
Hot flashes
Sweat

ClinicalTrials.gov processed this record on July 26, 2014