The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea

Phase 4

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Drug: Ayurved Siriraj Prasaplai with or without mefenamic acid; Drug: Placebo with or without mefenamic acid

• Registration Number: NCT01598012
• Lead Sponsor: Mahidol University

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 Description

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-09
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Primary Completion: 2013-07
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-26
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Woman who is diagnosed of primary dysmenorrhea.
• Woman who has regular menstruation.
• woman who has numeric rating score for pain during menstruation (dysmenorrhea) more than score 5 and continuous for 3 menstrual cycle.
• Woman who want to participate in this study.

Exclusion Criteria

• Woman who has allergic history for herbal or other components in Ayurved Siriraj Prasaplai drug.
• Woman who has hormonal contraception.
• Woman who has other diseases which is caused of abdominal pain.
• Breast feeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ayurved Siriraj Prasaplai	Ayurved Siriraj Prasaplai with or without mefenamic acid	-
placebo	Placebo with or without mefenamic acid	-

Primary Outcome Measures

Name	Time	Method
Pain score between experimental and placebo group	1 year	Compare pain score by using numeric rating scale (NRS) between the group of women who recieve Ayurved Siriraj Prasaplai with placebo group.

Secondary Outcome Measures

Name	Time	Method
To study about adverse effects of Ayurved Siriraj Prasaplai	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	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.

Trial Locations

Locations (1)

Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand