A Randomized Controlled Trial of Thai Herbal Prasaplai Formula for Primary Dysmenorrhea: Extend study

Phase 3

• Conditions: Primary dysmenorrheaMenstrual pain; Primary dysmenorrhea; Menstrual pain; Prasaplai; Thai traditional medicine; Pain relief; Body element

• Registration Number: TCTR20180523004
• Lead Sponsor: Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-23
• Study Completion: 2019-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

Women aged 18-45 years.
The menstrution cycle duration is 21 to 35 days.
Diagnosed with primary dysmenorrhea.
Pain scores higher than or equal 4 out of 10 on Numeric Rating Scores (NRS) lasting for 3 months.

Exclusion Criteria

History of allergy to ingredients contained in Plasaplai, starch and mefenamic.
Any gynecologic conditions confirmed of other pelvic pathologies by pelvic ultrasonography.
Placement of intrauterine devices or taking hormone.
History of abdominal surgery or other medical history which cause abdominal pain.
Using of any kind of analgesic drugs, medications or supplementary medicines.
Brest feeding, pregnant or likely to become pregnant within the next 6 months.
Blood transfusion within the last 3 months.
Smoking, alcoholism, or drug abuse.
Abnormal liver and renal functions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score at 3 months after end of the intervention Numeric rating scale

Secondary Outcome Measures

Name	Time	Method
relationship between body element and primary dysmenorrhea at 3 months after end of the intervention Characteristics of menstruation in T้hai Traditional Medicine,Safety at 3 months after end of the intervention questionnaire