Primary DysmenorrheaPhase 4NCT01598012
The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea
A Phase 4 study testing Ayurved Siriraj Prasaplai with or without mefenamic acid in people with Primary Dysmenorrhea, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Ayurved Siriraj Prasaplai with or without mefenamic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2011to Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
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.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Ayurved Siriraj Prasaplai with or without mefenamic acid, Placebo with or without mefenamic acid
- Keywords
- Ayurved Siriraj Prasaplai, primary dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ayurved Siriraj Prasaplai with or without mefenamic acidDrug
Also called Ponstan
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 acidDrug
Also called Ponstan
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)
| Study group | Role | What they receive |
|---|---|---|
| Ayurved Siriraj Prasaplai | Experimental | Not described Receives: Drug: Ayurved Siriraj Prasaplai with or without mefenamic acid |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo with or without mefenamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thanyarat Wongwananuruk, MD., Principal investigator, Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598012
- Sponsor's protocol ID
- R015535011
- Other IDs
- (IO)R015535011
- Status last verified
- Aug 2013
- First submitted
- 9 Apr 2012
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT01598012
- Acronym / sponsor ID
- R015535011
- Conditions
- Primary Dysmenorrhea
- Keywords
- Ayurved Siriraj Prasaplai, primary dysmenorrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ayurved Siriraj Prasaplai | Experimental | Drug: Ayurved Siriraj Prasaplai with or without mefenamic acid |
| placebo | Placebo comparator | Drug: Placebo with or without mefenamic acid |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ayurved Siriraj Prasaplai with or without mefenamic acidAlso: PonstanPrasaplai in capsule, 2 cap three times a day for 3 days. Mefenamic acid 500 mg prn for severe pain (as rescue medication) | Drug | Ayurved Siriraj Prasaplai |
| Placebo with or without mefenamic acidAlso: PonstanPlacebo 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) | Drug | placebo |
Primary outcome
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.
2 secondary outcomes
To study about adverse effects of Ayurved Siriraj Prasaplai
Time frame: 1 year
Number of mefenamic acid for breaking pain during study of both group
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
- Siriraj Institutional Review board (SIRB)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanyarat Wongwananuruk, MD. principal investigator
Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ayurved Siriraj Prasaplai with or without mefenamic acid in people with Primary Dysmenorrhea, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score between experimental and placebo group (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2013.