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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211011002
Enrollment
88
Registered
2021-10-11
Start date
2019-07-31
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women who have diagnosis with Primary Dysmenorrhea. Primary Dysmenorrhea Prasaplai Thai herbal medicine Menstruation

Interventions

The dosage of Prasaplai for research takes two capsules three times per day before meals beginning on three days before menstruation and two days in menstruation continually 3 months.,The dosage of pl
Experimental Drug,Placebo Comparator No treatment
Prasaplai,Placebo

Sponsors

Agricultural Research Development Agency
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
pain score every month, continually 3 months after intervention NRS

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactDarat kanlayananthaphecha

Mahidol University

darat.kan@mahidol.edu66895034662

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026