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Study aim
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Determining and comparing the average of primary dysmenorrhea pain intensity in women receiving bromelain and placebo, before and after the intervention.
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Design
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A clinical trial with a control group, with parallel groups, triple-blind, randomized block
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Settings and conduct
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In this study, patients are randomly divided into two groups. The first group receives Anaheal GDU500 capsules (containing 200 mg bromelain GDU/g 2500), (GDU= Gelatin Digesting Unit) and the second group receives placebo. In order not to identify, both groups are prepared in uniform packaging and a unique code will be used on each. The reception of drug and placebo will be checked in two cycles and in these two cycles, they will receive every 8 hours for 3 days in the first three days of the menstrual cycle. The first month, non of the groups receive any medication, just answer questionnaires for baseline information. Medicines will be received for 2 months. Finally, the data will be collected at the end of each drug receiving day, with two questionnaires, Visual analogue Scale and Moos Menstrual Questionnaire, and will be analyzed with descriptive and analytical statistical methods by SPSS software.
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Participants/Inclusion and exclusion criteria
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Entry requirements: having a certain age range with a certain weight and regular and painful menstrual cycles
Conditions of non-entry: having underlying and chronic diseases and sensitivity to herbal compounds, menstrual and abdominal-pelvic problems, using contraceptive pills, and having stress and mental problems
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Intervention groups
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The intervention group is 45 patients who take the Anaheal capsule three times a day for three days in two menstrual cycles.
The control group is 45 patients who take the placebo capsule three times a day for three days in two menstrual cycles.
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Main outcome variables
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Investigating the effectiveness of bromelain extract on primary dysmenorrhea pain