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.
|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|
- Hot flushes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change in frequency of hot flushes from baseline to week 12.
- 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 ]
- 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 ]
|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)|
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
Containing 2% of Qing'E pills
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805765
|Contact: Zheng Qingshan, Doctorfirstname.lastname@example.org|
|Shanghai University of Traditional Chinese Medicine||Recruiting|
|Shanghai, Shanghai, China, 201108|
|Study Chair:||Qingshan Zheng, Doctor||Shanghai Universitu of TCM|