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

Phase 3

Suspended

• Conditions: Women who have diagnosis with Primary Dysmenorrhea.; Primary Dysmenorrhea; Prasaplai; Thai herbal medicine; Menstruation

• Registration Number: TCTR20211011002
• Lead Sponsor: Agricultural Research Development Agency

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-06-30
• Study Start: 2021-10-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

1. Aged 18-45 years, 2. Regular menstrual cycle duration is 21 to 35 days, 3. Diagnosed with primary dysmenorrhea, 4. Pain scores higher than or equal 4 out of 10 on Numeric Rating Scales (NRS) lasting for 3 months.

Exclusion Criteria

1. History of allergy to ingredients contained in PSP, starch and mefenamic, 2. Any gynecologic conditions confirmed of other pelvic pathologies by pelvic ultrasonography, 3. Placement of intrauterine devices, 4. Other abdominal surgery in 1 year or medical history which can cause abdominal pain such as gallbladder, gallstone, dyspepsia, or irritable bowel syndrome, 5. Using of any kind of analgesic drugs, medications, hormones, or supplementary medicines, 6. Breastfeeding period, pregnant or likely to become pregnant within the next 6 months, 7. Blood transfusion within the last 3 months, 8. Smoking, alcoholism, or drug abuse, 9. Abnormal liver and renal functions with symptoms.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain score every month, continually 3 months after intervention NRS

Secondary Outcome Measures

Name	Time	Method
Safty screening, after intervention every month (3 months), and follow up Blood chemistry,Metabolomic profile screening, after intervention every month (3 months), and follow up Compound