Chinese Medicine Therapy on Menopausal Symptoms - Full Text View

Sponsor:	The University of Hong Kong
Information provided by:	The University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00799734

Purpose

The objective of this study is to evaluate whether a Chinese medicine formula (Erxian Decoction，EXD) is effective in alleviating menopausal symptoms, improve sex hormone profile and bone turn-over.

Condition	Intervention
Menopause	Other: Er-xian Decoction

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 ,the MENQOL Questionnaire and the MRS. 2)hormone indices 3) bone markers4)safety indices [ Time Frame: every four weeks ] [ Designated as safety issue: Yes ]
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 ]
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:

Hormone indices:serum follicle-stimulating hormone (FSH),luteinizing hormone (LH),estradiol, progesterone levels. The questionnaire of Menopausal Syndrome in Chinese Medicine. [ Time Frame: at the baseline and endpoint ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
alternative medicine: Experimental Intake of prepacked Chinese herbal medicine therapy (EXD), one sachet of granules (15g extracted granules) twice a day	Other: Er-xian Decoction 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.
placebo: Placebo Comparator placebo therapy of 15g granules with similar colour and taste.	Other: Er-xian Decoction 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.

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

Contacts

Contact: Yao Tong, PhD

852-2589-0476

tongyao@hku.hk

Locations

China
Chinese Medicine Clinic cum Training and Research Centers of the University of Hong Kong	Recruiting
Hong Kong, China
Contact: Zhang-jin Zhang, PhD 2589-0445 zhangzj@hku.hk
Principal Investigator: Zhang-jin Zhang, PhD

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, HKU ( School of Chinese Medicine, Li Ka Shing Faculty of Medicine, HKU )
Study ID Numbers:	HKCTR-740
Study First Received:	November 28, 2008
Last Updated:	January 19, 2010
ClinicalTrials.gov Identifier:	NCT00799734 History of Changes
Health Authority:	Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:

hot flushes
night sweats
osteoporosis

ClinicalTrials.gov processed this record on February 08, 2010