Chinese Medicine Therapy on Menopausal Symptoms

NCT00799734 | Completed DMC

• 1 other identifier: HKCTR-740
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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.

Conditions

Menopause

Keywords

hot flushes; night sweats; menopausal symptoms; osteoporosis; complementary and alternative medicine

Outcome Measures

Primary Outcomes (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).

  every four weeks

Secondary Outcomes (2)

• bone markers (N-MID osteocalcin and serum crosslaps)

  12 weeks

• Serum follicle-stimulating hormone (FSH), luteinizing hormone(LH), estradiol, progesterone levels

  12 weeks

Study Arms (2)

alternative medicine

ACTIVE COMPARATOR

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

Drug: EXD

placebo

PLACEBO COMPARATOR

placebo therapy of 15g granules with similar colour and taste.

Drug: EXD

Interventions

EXD 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.

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

alternative medicine; placebo

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Department of Obstetrics and Gynecology, the University of Hong Kong

Hong Kong, Hksar, China

Location

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

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Hot Flashes; Osteoporosis

Interventions

dixanthogen; er-xian decoction

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yao Tong, PhD

  School of Chinese Medicine, HKU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2008
• First Posted: December 1, 2008
• Study Start: April 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: July 26, 2011

Record last verified: 2011-07

Locations

CN (2)