The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea

Mahidol University40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Primary Dysmenorrhea

Interventions

Ayurved Siriraj Prasaplai with or without mefenamic acidDRUG

Prasaplai in capsule, 2 cap three times a day for 3 days. Mefenamic acid 500 mg prn for severe pain (as rescue medication)

Placebo with or without mefenamic acidDRUG

Placebo in capsule (physically identical appearance as Prasaplai) 2 cap three times a day for 3 days. Mefenamic acid 500 mg prn for severe pain, every 6 hours (rescue medication)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Outcomes

Primary Outcomes

Pain score between experimental and placebo group

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

Time frame: 1 year

Secondary Outcomes

To study about adverse effects of Ayurved Siriraj Prasaplai

To study about adverse effects such as skin rash, nausea vomitting, palpitation, jaundice, hypersensitivity symptoms during treatment with Ayurved Siriraj Prasaplai or placebo.

Time frame: 1 year

Number of mefenamic acid for breaking pain during study of both group

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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