Conditions: Primary Dysmenorrhea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 280
Healthy volunteers: no

Brief summary:
The purpose of this study is to further assess the efficacy, safety and dose-response of KYG0395 in the treatment of primary dysmenorrhea.

Detailed description:
Compare the effect and safety of the investigational drug and placebo on dysmenorrhea in adult otherwise healthy women.

Arms:
arm 1: Patients received high dose KYG0395 capsule (tid) arm 2: Patients received lower dose KYG0395 capsule (bid) arm 3: Patients received placebo (tid)

Interventions: intervention 1: high dose KYG0395 intervention 2: lower dose KYG0395 intervention 3: Placebo
Intervention descriptions: intervention 1: 3 KYG0395 capsules tid (morning, midday, and evening) intervention 2: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday) intervention 3: 3 capsules of placebo tid (morning, midday, and evening)

Protocol document: