Chinese Medicine Therapy on Menopausal Symptoms

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799734
• Other study ID #: HKCTR-740
• Status: Completed
• Phase: N/A
• First received: November 28, 2008
• Last updated: July 25, 2011
• Start date: April 2009
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	bone markers (N-MID osteocalcin and serum crosslaps)		12 weeks	Yes
Secondary	Serum follicle-stimulating hormone (FSH), luteinizing hormone(LH), estradiol, progesterone levels		12 weeks	Yes