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The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea

NCT ID: NCT01598012

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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

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Primary Dysmenorrhea

Keywords

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Ayurved Siriraj Prasaplai primary dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ayurved Siriraj Prasaplai

Group Type EXPERIMENTAL

Ayurved Siriraj Prasaplai with or without mefenamic acid

Intervention Type DRUG

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

placebo

Group Type PLACEBO_COMPARATOR

Placebo with or without mefenamic acid

Intervention Type 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)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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Ponstan Ponstan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thanyarat Wongwananuruk, MD.

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Endocrinology Unit, Department of Obstetric and Gynecology

Locations

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

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Related Links

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http://www.si.mahidol.ac.th/Th/division/sirb/

Siriraj Institutional Review board (SIRB)

Other Identifiers

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(IO)R015535011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R015535011

Identifier Type: -

Identifier Source: org_study_id