Primary Dysmenorrhea Clinical Trial
Official title:
The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea
Verified date | August 2013 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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 |
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