Chinese Medicine Therapy on Menopausal Symptoms

NCT ID: NCT00799734

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-06-30

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.

Conditions

Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

alternative medicine

Intake of prepacked Chinese herbal medicine (EXD), one sachet of granules (15g extracted granules) twice a day

Group Type: ACTIVE_COMPARATOR

EXD

Intervention Type: DRUG

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 therapy of 15g granules with similar colour and taste.

Group Type: PLACEBO_COMPARATOR

EXD

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Er-xian Decoction (Prod. Code:3PP3082-3083)

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

School of Chinese Medicine, HKU

Principal Investigators

Yao Tong, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Chinese Medicine, HKU

Locations

Department of Obstetrics and Gynecology, the University of Hong Kong

Hong Kong, Hksar, China

Chinese Medicine Clinic cum Training and Research Centers of the University of Hong Kong

Hong Kong, Hong Kong, China

Countries

China

Other Identifiers

HKCTR-740

Identifier Type: -

Identifier Source: org_study_id