The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea
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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 |
- 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.
- 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.
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | July 2012 (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 |
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| Contact: Thanyarat Wongwananuruk, MD. | 6624197000 ext 4657-8 | sitwn@mahidol.ac.th |
| Thailand | |
| Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting |
| Bangkok, Thailand, 10700 | |
| Contact: Thanyarat Wongwananuruk, MD. 6624197000 ext 4657-8 sitwn@mahidol.ac.th | |
| Principal Investigator: Thanyarat Wongwananuruk, MD. | |
| Principal Investigator: | Thanyarat Wongwananuruk, MD. | Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology |
More Information
Additional 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: | May 14, 2012 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Mahidol University:
|
Ayurved Siriraj Prasaplai primary dysmenorrhea |
Additional relevant MeSH terms:
|
Menstruation Disturbances Dysmenorrhea Pathologic Processes Pelvic Pain Pain Signs and Symptoms Mefenamic Acid Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013