CompletedPhase 2ACTRN12608000630314

Chinese herbal medicine for Primary Dysmenorrhea.

A randomised, double-blind, placebo controlled clinical trial of the effectiveness of Chinese herbal medicine in the management of primary dysmenorrhea.

Sponsor

University of Western Sydney

Enrollment

120 participants

Start Date

Mar 1, 2004

Study Type

Interventional

Conditions

Primary Dysmenorrhea

Summary

This is a randomised, double-blind placebo controlled trial in the use of Chinese herbal medicine in the management of primary dysmenorrhea in Australia. This investigation seeks to establish whether Chinese herbs offer any beneficial effect in the management of this disorder. Dysmenorrhea is a common gynaecological complaint among adolescent girls and women of reproductive age and refers to the occurrence of painful menstrual cramps of lower abdominal origin. This trial will include the assessment of Chinese herbs in standard and individual formulas against placebo.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for women aged 18 to 45 who experience painful periods (primary dysmenorrhea) with lower abdominal pain for at least 3 menstrual cycles. It investigates whether Chinese herbal medicine can help relieve menstrual pain. Participants take the herbal treatment and report their pain levels over several cycles.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Chinese herbal medicine extract in an oral powder form. Intervention Group 1 – standard Chinese herbal formula. Intervention Group 2 – Individualised Chinese herbal formula. The dosage is for 10 days per menstrual cycle for three months treatment. Taking 6g/day twice per day mixed with warm water, commencing one week prior to bleeding (between days 20-28 of the cycle) until the third day of the cycle (during menstrual bleeding). The formulation ingredients currently remain commercial-in-confidence.