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. 2016 Mar 22;2016(3):CD002124. doi: 10.1002/14651858.CD002124.pub2

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
  • Pain score by using NRS.


Secondary
  • Adverse effects of Ayurved Siriraj Prasapla

  • number of mefenamic acid for breaking pain.

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