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Qing'E Formula Therapy on Menopausal Symptoms

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ClinicalTrials.gov Identifier: NCT01805765
Recruitment Status : Unknown
Verified March 2013 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : March 6, 2013
Last Update Posted : March 6, 2013
Sponsor:
Collaborators:
Longhua Hospital
Shanghai Yueyang Integrated Medicine Hospital
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai Putuo District Center Hospital
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

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

Condition or disease Intervention/treatment Phase
Menopause Drug: Qing'E pills Drug: Placebo Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Hot flushes [ Time Frame: 12 weeks ]
    Change in frequency of hot flushes from baseline to week 12.


Secondary Outcome Measures :
  1. Hot flushes [ Time Frame: 4 weeks, 8 weeks ]
    Change in frequency of hot flushes from baseline to week 4 and week 8.

  2. Hot flushes [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]
    Decline rate of hot flushes from baseline to week 4, week 8 and week 12;

  3. Mean differences of Kupperman index [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]
    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)

  4. Mean difference of single clinical symptom in Kupperman index [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Nerve-endocrine-immune (NEI) network profile [ Time Frame: 12 weeks ]

    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


  2. Urine metabolomics [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]


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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. 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.

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): 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 Integrated Medicine Hospital
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai Putuo District Center Hospital
Investigators
Study Chair: Qingshan Zheng, Doctor Shanghai Universitu of TCM

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01805765     History of Changes
Other Study ID Numbers: QE-2458-1
SHU-5366432 ( Other Identifier: Shanghai University of TCM )
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013

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