Clinical Trial: The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea

Brief Summary: Ayurved Siriraj Prasaplai is a Thai traditional herbal drug for pain treatment. Mostly it was used for antipain during menstruation or dysmenorrhea. This drug has been described by alternative medical doctor for treatment of primary dysmenorrhea for more than 10 years and showed clinical satisfied response. From review about this agent, it does not have clinical trial to prove its efficacy. So the author produce this research to study in efficacy of Ayurved Siriraj Prasaplai.

Detailed Summary: The participants were allocated in the study by block randomization and double blind. In experiment-group was treated with Ayurved Siriraj Prasaplai and control-group was treated with placebo (non-active agent). Both of drug was made in the same appearance of capsule (size and color). The participants have to start the drug when they have menstruation after that the dosage is 2 capsules for 3 times per day (after-meal) continue to 3 days. The participant have to record pain score (minimal/maximal/mean score) and multidimensional score in daily card, side effect and satisfaction. If the participant couldn't tolerate the pain, they could break the pain with mefenamic acid. They have record number of mefenamic acid which they used too. This study evaluate in only one cycle. After complete record, the participant come back to investigator for sending the report.
Sponsor: Mahidol University

Current Primary Outcome: Pain score between experimental and placebo group [ Time Frame: 1 year ]

Compare pain score by using numeric rating scale (NRS) between the group of women who recieve Ayurved Siriraj Prasaplai with placebo group.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To study about adverse effects of Ayurved Siriraj Prasaplai [ Time Frame: 1 year ]
    To study about adverse effects such as skin rash, nausea vomitting, palpitation, jaundice, hypersensitivity symptoms during treatment with Ayurved Siriraj Prasaplai or placebo.
  • Number of mefenamic acid for breaking pain during study of both group [ Time Frame: 1 year ]
    During experiment if participant couldn't tolerate the pain which be treated with Ayurved Siriraj Prasaplai or placebo, they could have breaking pain(rescue treatment) with mefenamic acid. Then the participant have to record the number of mefenamic acid and timing which they used in record form.


Original Secondary Outcome: Same as current

Information By: Mahidol University

Dates:
Date Received: April 9, 2012
Date Started: December 2011
Date Completion:
Last Updated: August 26, 2013
Last Verified: August 2013