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Completed

NCT Number: NCT01805765

Qing'E Formula Therapy on Menopausal Symptoms

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

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Key information

Conditions

Menopause Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201108, China

About this study

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.

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.
  • 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

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

Treatment and study plan

Qing'E pills

Drug

composed of eucommia, psoralen, walnuts and garlic

Placebo

Drug

Containing 2% of Qing'E pills

Primary outcomes

  1. Hot flushes

    Time frame: 12 weeks

    Change in frequency of hot flushes from baseline to week 12.

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Longhua Hospital
  • Shanghai Municipal Hospital of Traditional Chinese Medicine
  • Shanghai Putuo District Center Hospital
  • Shanghai Yueyang Integrated Medicine Hospital

Registry information

Official study title

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial on the Effects of Chinese Medicine Formula (Qing'E) on Menopausal Symptoms

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2013
Registry last updated
Apr 5, 2019

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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