NCT01598012.
Trial name or title | The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea |
Methods | Block randomisation and double blinded |
Participants | Inclusion: women diagnosed with primary dysmenorrhoea, with regular menstruation; has a numeric rating score for pain during menstruation (dysmenorrhoea) > 5 and continuous for 3 menstrual cycles, and want to participate in this study. Exclusion: women with allergy history to herbal or other components in Ayurved Siriraj Prasaplai drug; using hormonal contraception; has other diseases which cause abdominal pain; breast feeding Location: Thailand |
Interventions | Group 1: Ayurved Siriraj Prasaplai with or without mefenamic acid. Prasaplai in capsule, 2 capsules 3 times a day for 3 days. Mefenamic acid 500 mg prn for severe pain (as rescue medication). Other name: Ponstan Group 2: Placebo with or without mefenamic acid. Placebo in a capsule (physically identical appearance to Prasaplai) 2 capsules 3 times a day for 3 days. Mefenamic acid (Ponstan) 500 mg prn for severe pain, every 6 hours (rescue medication) |
Outcomes |
Primary
Secondary
|
Starting date | December 2011 |
Contact information | Thanyarat Wongwananuruk, Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 |
Notes | Data collection has finished. As of November 2014 the study authors are writing up their results. Not published at February 2016. |
prn: as needed
qd: every day / daily
OCP: oral contraceptive pills