Clinical trial NCT01598012: The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea
Official title: The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Dysmenorrhea
Keywords: Ayurved Siriraj Prasaplai
primary dysmenorrhea
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score between experimental and placebo group
timeFrame: 1 year
Secondary outcomes:
measure: To study about adverse effects of Ayurved Siriraj Prasaplai
timeFrame: 1 year
measure: Number of mefenamic acid for breaking pain during study of both group
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology
name: Thanyarat Wongwananuruk, MD.
role: PRINCIPAL_INVESTIGATOR
References: