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eardngam, alternative dysmenorrhea treatments besides NSAIDs: a randomized clinical trial

Phase 3
Completed
Conditions
Primary dysmenorrhea in young adult females
dysmenorrhea, young adult, mefenamic acid, herbal medicine, Thai Traditional Medicine, randomized controlled trial
Registration Number
TCTR20200608004
Lead Sponsor
Department of Thai Traditional and Alternative Medicine
Brief Summary

This study concludes that the effectiveness of Leardngam for menstrual pain alleviation was comparable to that of mefenamic acid. It caused less gastrointestinal distress than mefenamic acid and had no effect on the menstrual cycle. Women with primary dysmenorrhea may use it as an alternative or a supplement.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
240
Inclusion Criteria

[1]Dysmenorrhea (Numeric rating scale >3)
[2]frequency of dysmenorrhea >80% of cycle
[3]Regular menstruation
[4]No underlying illness
[5]No other gynecologic disorders
[6]No concurrent of drug; steroid, NSAIDs, anti-platelet, anti-hypertension, magnesium hydroxide, cyclosporin
[7]Normal level of laboratory chemistry values
[8] No history of drug/herb allery
[9] understanding thai language
[10] Normal mental status
[11] not pregnant status

Exclusion Criteria

Medical complication during the trial
Drug allery during the trial
Abnormal laboratory chemistry values
Abnormal finding in pelvis by u/s
pregnancy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
dysmenorrhea intensity at the end of each cycle for three consecutive cycles Numeric rating scale,adverse effect at the end of each cycle for three consecutive cycles questionnaire, Fibser scale
Secondary Outcome Measures
NameTimeMethod
Menstrual characteristic at the end of each cycle for three consecutive cycles Questionnaires, and Pictorial Blood Loss Assessment Chart (PBAC)
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