The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598012
• Other study ID #: R015535011
• Secondary ID: (IO)R015535011
• Status: Completed
• Phase: Phase 4
• First received: April 9, 2012
• Last updated: August 26, 2013
• Start date: December 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

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)
• 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)

Locations

Country	Name	City	State
Thailand	Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Secondary	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.	1 year	Yes
Secondary	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.	1 year	No

External Links

•   Siriraj Institutional Review board (SIRB)