None listed
Conditions
Brief 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.
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-confiden
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.
Sponsors
University of Western Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Pain in the lower abdomen in relation to menstruation over at least the last three menstrual cycles.
Exclusion criteria
1. History of any pelvic organic disorder 2. Taking any form of contraceptive 3. Hypertension, diabetes, hepatic disorder, renal disorder, psychological diagnosis 4. Pregnancy
Outcome results
None listed