The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea
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|ClinicalTrials.gov Identifier: NCT01598012|
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : August 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Primary Dysmenorrhea||Drug: Ayurved Siriraj Prasaplai with or without mefenamic acid Drug: Placebo with or without mefenamic acid||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||August 2013|
|Experimental: Ayurved Siriraj Prasaplai||
Drug: Ayurved Siriraj Prasaplai with or without mefenamic acid
Prasaplai in capsule, 2 cap three times a day for 3 days. Mefenamic acid 500 mg prn for severe pain (as rescue medication)
Other Name: Ponstan
|Placebo Comparator: placebo||
Drug: Placebo with or without mefenamic acid
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)
Other Name: Ponstan
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598012
|Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University|
|Bangkok, Thailand, 10700|
|Principal Investigator:||Thanyarat Wongwananuruk, MD.||Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology|