An interventional study of EXD in Menopause, sponsored by The University of Hong Kong. Completed at 2 sites in China. Open to female participants aged 45 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-26.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
The objective of this study is to evaluate whether a Chinese medicine formula (Erxian Decoction，EXD) is effective in alleviating menopausal symptoms, improving sex hormone profile and bone turn-over.
This is a double-blind randomized placebo-controlled clinical trial to evaluate whether a Chinese medicine formula (Erxian Decoction) is effective in alleviating menopausal symptoms. This study will be conducted in Queen Mary Hospital and Chinese Medicine Clinic cum Training and Research Centers of the University of Hong Kong (Sassoon Road and Central). Women will be recruited from the general population by advertisements and promotion through media coverage.108 Chinese women with menopausal symptoms will be recruited and randomized into two groups.One is treatment group with 12 weeks of Erxian Decoction (well-controlled granules), 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 plus night sweats),the Menopause-Specific Quality of Life (MENQOL) Questionnaire and the Menopause Rating Scale(MRS). 2)biochemical indices:serum follicle-stimulating hormone(FSH),luteinizing hormone(LH),estradiol, progesterone levels. 3)safety indices: blood count,liver and renal function tests. All measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms and MENQOL Questionnaire, MRS. We expect this research will provide an effective and low-cost therapy for menopausal symptoms.
The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intake of prepacked Chinese herbal medicine (EXD), one sachet of granules (15g extracted granules) twice a day
Drug: EXD
placebo therapy of 15g granules with similar colour and taste.
Drug: EXD
Interventions: Intake of prepacked Chinese herbal medicine therapy (EXD), one sachet of granules (15g extracted granules) twice a day and placebo therapy of 15g granules with similar colour and taste.
Also known as: Er-xian Decoction (Prod. Code:3PP3082-3083)
The severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes plus night sweats),the Menopause-Specific Quality of Life (MENQOL) Questionnaire and the Menopause Rating Scale(MRS).
Time frame: every four weeks
bone markers (N-MID osteocalcin and serum crosslaps)
Time frame: 12 weeks
Serum follicle-stimulating hormone (FSH), luteinizing hormone(LH), estradiol, progesterone levels
Time frame: 12 weeks
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong