The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea

Mahidol University

Status and phase

Completed

Phase 4

Conditions

Primary Dysmenorrhea

Treatments

Drug: Ayurved Siriraj Prasaplai with or without mefenamic acid

Drug: Placebo with or without mefenamic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01598012

R015535011

(IO)R015535011 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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