Qing'E Formula Therapy on Menopausal Symptoms

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

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Drug: Qing'E pills; Drug: Placebo

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
• Enrollment (Actual): 240
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201108
      • Shanghai University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hot flushes	Change in frequency of hot flushes from baseline to week 12.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hot flushes	Change in frequency of hot flushes from baseline to week 4 and week 8.	4 weeks, 8 weeks
Hot flushes	Decline rate of hot flushes from baseline to week 4, week 8 and week 12;	4 weeks, 8 weeks and 12 weeks
Mean differences of Kupperman index	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 weeks, 8 weeks and 12 weeks
Mean difference of single clinical symptom in Kupperman index		12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nerve-endocrine-immune (NEI） network profile	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	12 weeks
Urine metabolomics		4 weeks, 8 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Shanghai Yueyang Integrated Medicine Hospital; Longhua Hospital; Shanghai Putuo District Center Hospital; Shanghai Municipal Hospital of Traditional Chinese Medicine
• Investigators: Study Chair: Qingshan Zheng, Doctor, Shanghai Universitu of TCM

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (ESTIMATE): March 6, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Hot flashes; Sweat; menopausal syndrome; climacteric syndrome
• Other Study ID Numbers: QE-2458-1; SHU-5366432 (OTHER: Shanghai University of TCM)