Health Condition 1: N944- Primary dysmenorrhea Health Condition 2: null- primary dysmenorrhoea
Conditions
Interventions
Intervention1: Lornoxicam: Lornoxicam 8mg twice a day for 3 days of moderate to severe menstrual cycle
Control Intervention1: Lornoxicam and Ibuprofen: Ibuprofen 400mg BD for 3 days
Lornoxicam 8mg
Sponsors
Government Medical College Bhavnagar
Eligibility
Inclusion criteria
Inclusion criteria: ?Healthy women of 18 to 40 years of age groups ?Regular menstrual cycle (21 ? 35 days) ?With moderate or severe pain and self assessment of dysmenorrhoea ?History of primary dysmenorrhoea within 3 to 4 years of menarche ?Willing for non pregnant status during entire study period ?History of at least 6 month of menstrual cramping pain which last for 2 days of each menstrual cycle ?Patient who voluntary participate in the study with signed inform consent
Exclusion criteria
Exclusion criteria: ?Patient having secondary dysmenorrhoea ?Patient having mild menstrual pain ?Patient with any valvular heart disease or acute abdominal condition ?Patient with history of severe gastritis, peptic ulceration or any g.i.t bleeding ?Patient taking regular NSAIDs for some therapeutic indication for pain relief other than menstrual pain ?Patient underwent for some surgical procedure or IUD insertion or injectable contraceptive before the 4 month of study ?Patient allergic to any NSAIDs ?Patient on ACE inhibitors, platelet aggregation inhibitors, diuretics or anti diabetic drugs ?Taking rescue medication within the 1 hour of trial medication during study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pain relief scoreTimepoint: 2,4,6,8, 12, 24, 72 hours after post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Safety and tolerability of will be assessed by the number of patients with clinical adverse experiencesTimepoint: At the end of the study | — |
Countries
India
Contacts
Public ContactDr Jayshree Chimanbhai Patel
Government Medical College, Bhavnagar
Outcome results
None listed