The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea

NCT01598012 | Completed Phase 4

• 2 other identifiers: R015535011(IO)R015535011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

Ayurved Siriraj Prasaplai; primary dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• To study about adverse effects of Ayurved Siriraj Prasaplai

  1 year

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

  1 year

Study Arms (2)

Ayurved Siriraj Prasaplai

EXPERIMENTAL

Drug: Ayurved Siriraj Prasaplai with or without mefenamic acid

placebo

PLACEBO COMPARATOR

Drug: Placebo with or without mefenamic acid

Interventions

Ayurved Siriraj Prasaplai with or without mefenamic acid DRUG

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

Also known as: Ponstan

Ayurved Siriraj Prasaplai

Placebo with or without mefenamic acid DRUG

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)

Also known as: Ponstan

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

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

Bangkok, Bangkok, 10700, Thailand

Location

Related Links

• Siriraj Institutional Review board (SIRB)

MeSH Terms

Interventions

Mefenamic Acid

Intervention Hierarchy (Ancestors)

Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Thanyarat Wongwananuruk, MD.

  Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2012
• First Posted: May 15, 2012
• Study Start: December 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

TH (1)