Comparative randomised cross-over study of the efficacy and safety of the extract of the roots of the South-African Uzara plant and ibuprofen in the treatment of patients with primary dysmenorrhoea

Ain Shams University Maternity Hospital (Egypt)0 个研究点目标入组 60 人开始时间: 2011年1月31日最近更新: 2016年10月17日

试验速览

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•1. Female students attending clinical classes in medicine (Faculty of Medicine) or nursing (High Institute of Nursery) at Ain Shams University Maternity Hospital and having moderate or severe spasmodic dysmenorrhoea (history of at least 6 consecutive months of moderate to severe dysmenorrhoea, with the pain starting one day before or on the day of onset of bleeding and lasting at least 1 day during menstruation) and requiring analgesic use for pain relief, in each of the last 3 consecutive cycles preceding admission into the study.
•2. Aged 18 - 28 years of age at the time of the study
•3. Regular cycles lasting 21 to 35 days with the actual menses periods lasting three to seven days
•4. Signed written informed consent by the student to participate in the study

•1. Students who are/were married or planning to get married during the study period
•2. Students on hormonal therapy during the last 6 months or those planning to take hormonal therapy including oral contraceptives during the study period
•3. Known or suspected secondary dysmenorrhoea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease [PID], ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, irritable bowel syndrome)
•4. History of significant chronic constipation and/or recurrent colitis
•5. Serious medical condition: having evidence of clinically relevant gynaecological, cardiovascular, haematologic, hepatic, gastrointestinal (especially active or severe peptic ulceration, or history thereof), renal, pulmonary (especially bronchial asthma or history thereof), endocrinologic, autoimmune diseases, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations
•6. Regular intake of medications that are not allowed in the study (pain medications for any other reason including non-steroidal anti-inflammatory drugs [NSAIDs], digoxin, antidepressants, tranquilizers, hypnotics, sedatives, or sex hormones)
•7. Any concomitant disease of condition that might require any intake of analgesic medication
•8. Unwilling to comply with the protocol
•9. Participation in another clinical trial in the last 3 months prior to the start of this study

发起方

Ain Shams University Maternity Hospital (Egypt)