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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
TCTR20180523004
Enrollment
88
Registered
2018-05-23
Start date
2018-06-01
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

Primary dysmenorrhea Menstrual pain Primary dysmenorrhea Menstrual pain Prasaplai Thai traditional medicine Pain relief Body element

Interventions

Placebo capsule consist of starch 500 mg. take two capsules three times per day before meals consecutive for 3 months.,Prasaplai capsule 500 mg. take two capsules three times per day before meals con
Placebo Comparator Drug,Placebo Comparator Drug
Placebo,Prasaplai

Sponsors

Mahidol University
Lead Sponsor
Siriraj Hospital
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Pain score at 3 months after end of the intervention Numeric rating scale

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactPanicha Chantrapanichkul

Siriraj Hospital

panichachan@hotmail.com0869952264

Outcome results

None listed

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