Qing'E Formula Therapy on Menopausal Symptoms

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805765
• Other study ID #: QE-2458-1
• Secondary ID: SHU-5366432
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2013
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• Qing'E pills
composed of eucommia, psoralen, walnuts and garlic
• Placebo
Containing 2% of Qing'E pills

Locations

Country	Name	City	State
China	Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Longhua Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Putuo District Center Hospital, Shanghai Yueyang Integrated Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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-a?IL-6?IL-1; Cardiovascular indicators: ET, NO, Hcy, Folic acid	12 weeks
Other	Urine metabolomics		4 weeks, 8 weeks and 12 weeks
Primary	Hot flushes	Change in frequency of hot flushes from baseline to week 12.	12 weeks
Secondary	Hot flushes	Change in frequency of hot flushes from baseline to week 4 and week 8.	4 weeks, 8 weeks
Secondary	Hot flushes	Decline rate of hot flushes from baseline to week 4, week 8 and week 12;	4 weeks, 8 weeks and 12 weeks
Secondary	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
Secondary	Mean difference of single clinical symptom in Kupperman index		12 weeks