CompletedPhase 2Phase 3ACTRN12608000617369

Complementary and Alternative Medicine and the menopausal transition: The effect of a Chinese Herbal Formula on Vasomotor symptoms and bone turnover.

A randomised placebo controlled double blind clinical trial on the effectiveness of a herbal formula to alleviate menopausal vasomotor symptoms.

Sponsor

Global Therapeutics Pty Ltd

Enrollment

90 participants

Start Date

Aug 1, 2004

Study Type

Interventional

Conditions

Menopause

Summary

Some evidence suggests that Chinese & western herbs may help reduce menopausal symptoms. Therefore, this study will investigate the effectiveness of a herbal formula to alleviate menopausal vasomotor symptoms and improve quality of life. The trial will consist of two arms, an intervention and a placebo group, with random assignment of participants. All participants and trial researchers will be blinded to treatment allocation. Preliminary data will also be gathered on the effect of herbal therapy on bone metabolic markers.

Eligibility

Sex: FemalesMin Age: 45 YearssMax Age: 65 Yearss

Inclusion Criteria2

Women with at least 12 months amenorrhoea aged between 45-65 years.
On average 6 episodes of vasomotor symptoms per day.

Exclusion Criteria4

Undiagnosed vaginal bleeding
History of breast cancer or cancer
Use of corticosteroids or anticoagulants
Uncontrolled and/or diagnosed medication conditions likely to interfere with the study treatment

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Interventions

Herbal medicine formulation in tablet form, with a dosage of 2 tablets twice per day for 16 weeks. The ingredients of the formulation remain commercial-in-confidence.