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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000617369

Enrollment

Registered

2008-12-08

Start date

2004-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

45 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Women with at least 12 months amenorrhoea aged between 45-65 years. 2. On average 6 episodes of vasomotor symptoms per day.

Exclusion criteria

1. Undiagnosed vaginal bleeding 2. History of breast cancer or cancer 3. Use of corticosteroids or anticoagulants 4. Uncontrolled and/or diagnosed medication conditions likely to interfere with the study treatment

Outcome results