Chinese Medicine Therapy on Menopausal Symptoms

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

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Drug: EXD

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Er-xian Decoction (Prod. Code:3PP3082-3083)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
bone markers (N-MID osteocalcin and serum crosslaps)	12 weeks
Serum follicle-stimulating hormone (FSH), luteinizing hormone(LH), estradiol, progesterone levels	12 weeks

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Yao Tong, PhD, School of Chinese Medicine, HKU

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: November 28, 2008
• First Submitted That Met QC Criteria: November 28, 2008
• First Posted (ESTIMATE): December 1, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 26, 2011
• Last Update Submitted That Met QC Criteria: July 25, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: osteoporosis; menopausal symptoms; hot flushes; complementary and alternative medicine; night sweats
• Other Study ID Numbers: HKCTR-740