The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01598012
First received: April 9, 2012
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Primary Dysmenorrhea
Drug: Ayurved Siriraj Prasaplai with or without mefenamic acid
Drug: Placebo with or without mefenamic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Pain score between experimental and placebo group [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare pain score by using numeric rating scale (NRS) between the group of women who recieve Ayurved Siriraj Prasaplai with placebo group.


Secondary Outcome Measures:
  • To study about adverse effects of Ayurved Siriraj Prasaplai [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: December 2011
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598012

Locations
Thailand
Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Thanyarat Wongwananuruk, MD. Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01598012     History of Changes
Other Study ID Numbers: R015535011, (IO)R015535011
Study First Received: April 9, 2012
Last Updated: August 26, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Ayurved Siriraj Prasaplai
primary dysmenorrhea

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Mefenamic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014