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

Inclusion Criteria1

Pain in the lower abdomen in relation to menstruation over at least the last three menstrual cycles.

Exclusion Criteria4

History of any pelvic organic disorder
Taking any form of contraceptive
Hypertension, diabetes, hepatic disorder, renal disorder, psychological diagnosis
Pregnancy

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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.