Chinese Medicine Therapy on Menopausal Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Double-blind Randomized Placebo-controlled Clinical Trial on the Effects of Chinese Medicine Formula (Erxian Decoction) on Menopausal Symptoms

Conditions
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Menopause

Intervention / Treatment
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* Drug: EXD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese women aged 45 to 55 years old having irregular menstrual cycles (≥3 months) indicating perimenopausal status or with cessation of menstrual period for at least three months within the previous 12 months Total scores of Menopause Rating Scale≥28 indicating the menopausal symptoms are moderate or severe Not having used HRT or Chinese Medicine for at least 3 months prior to entry into the study Willing to give informed ,written consent to participate in the clinical study Exclusion Criteria: Taking hormones or medications, which could affect the vasomotoric symptoms Having chronic illness, such as gastrointestinal, renal or liver disease, diabetes mellitus requiring treatment, uncontrolled hypertension Having serious diseases, such as cancer, autoimmune system diseases, thrombosis and thrombophlebitis Consuming alcohol, or taking psychiatric or psychotherapeutic drugs

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: alternative medicine<br>Intake of prepacked Chinese herbal medicine (EXD), one sachet of granules (15g extracted granules) twice a day | Drug: EXD<br>* 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.<br>* Other names: Er-xian Decoction (Prod. Code:3PP3082-3083);|
| Placebo Comparator: placebo<br>placebo therapy of 15g granules with similar colour and taste. | Drug: EXD<br>* 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.<br>* Other names: Er-xian Decoction (Prod. Code:3PP3082-3083);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | every four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone markers (N-MID osteocalcin and serum crosslaps) |  | 12 weeks | 
| Serum follicle-stimulating hormone (FSH), luteinizing hormone(LH), estradiol, progesterone levels |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hot flushes, night sweats, menopausal symptoms, osteoporosis, complementary and alternative medicine