Chinese Medicine Therapy on Menopausal Symptoms - Full Text View

Purpose

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.

Condition	Intervention
Menopause	Drug: EXD

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-blind Randomized Placebo-controlled Clinical Trial on the Effects of Chinese Medicine Formula (Erxian Decoction) on Menopausal Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Menopause Sweat

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

bone markers (N-MID osteocalcin and serum crosslaps) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Serum follicle-stimulating hormone (FSH), luteinizing hormone(LH), estradiol, progesterone levels [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	108
Study Start Date:	April 2009
Study Completion Date:	June 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: alternative medicine Intake of prepacked Chinese herbal medicine (EXD), one sachet of granules (15g extracted granules) twice a day	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. Other Name: Er-xian Decoction (Prod. Code:3PP3082-3083)
Placebo Comparator: placebo 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. Other Name: Er-xian Decoction (Prod. Code:3PP3082-3083)

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

Ages Eligible for Study:	45 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799734

Locations

China, Hksar
Department of Obstetrics and Gynecology, the University of Hong Kong
Hong Kong, Hksar, China
China, Hong Kong
Chinese Medicine Clinic cum Training and Research Centers of the University of Hong Kong
Hong Kong, Hong Kong, China

Sponsors and Collaborators

The University of Hong Kong

Investigators

Principal Investigator:

Yao Tong, PhD

School of Chinese Medicine, HKU

More Information

No publications provided

Responsible Party:	School of Chinese Medicine, Li Ka Shing Faculty of Medicine, HKU, School of Chinese Medicine, HKU
ClinicalTrials.gov Identifier:	NCT00799734 History of Changes
Other Study ID Numbers:	HKCTR-740
Study First Received:	November 28, 2008
Last Updated:	July 25, 2011
Health Authority:	Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:

hot flushes
night sweats
menopausal symptoms
osteoporosis
complementary and alternative medicine

ClinicalTrials.gov processed this record on May 16, 2013