Clinical trial NCT00799734: Chinese Medicine Therapy on Menopausal Symptoms
Official title: A Double-blind Randomized Placebo-controlled Clinical Trial on the Effects of Chinese Medicine Formula (Erxian Decoction) on Menopausal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: hot flushes
night sweats
menopausal symptoms
osteoporosis
complementary and alternative medicine
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2008-12-01
Enrollment: 108
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Chinese women aged 45 to 55 years old
2. 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
3. Total scores of Menopause Rating Scale≥28 indicating the menopausal symptoms are moderate or severe
4. Not having used HRT or Chinese Medicine for at least 3 months prior to entry into the study
5. Willing to give informed ,written consent to participate in the clinical study

Exclusion Criteria:

1. Taking hormones or medications, which could affect the vasomotoric symptoms
2. Having chronic illness, such as gastrointestinal, renal or liver disease, diabetes mellitus requiring treatment, uncontrolled hypertension
3. Having serious diseases, such as cancer, autoimmune system diseases, thrombosis and thrombophlebitis
4. Consuming alcohol, or taking psychiatric or psychotherapeutic drugs

Primary outcomes:
measure: 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).
timeFrame: every four weeks
Secondary outcomes:
measure: bone markers (N-MID osteocalcin and serum crosslaps)
timeFrame: 12 weeks
measure: Serum follicle-stimulating hormone (FSH), luteinizing hormone(LH), estradiol, progesterone levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Obstetrics and Gynecology, the University of Hong Kong
state: Hksar
city: Hong Kong
country: China
facility: Chinese Medicine Clinic cum Training and Research Centers of the University of Hong Kong
state: Hong Kong
Study officials:
affiliation: School of Chinese Medicine, HKU
name: Yao Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References: