A clinical trial to study the effects of two drugs, Lornoxicam and Ibuprofen in moderate to severe menstrual cramping pain due to primary dysmenorrhoea
- Conditions
- Health Condition 1: N944- Primary dysmenorrheaHealth Condition 2: null- primary dysmenorrhoea
- Registration Number
- CTRI/2011/12/002188
- Lead Sponsor
- Government Medical College Bhavnagar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 75
?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
?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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total pain relief scoreTimepoint: 2,4,6,8, 12, 24, 72 hours after post dose
- Secondary Outcome Measures
Name Time Method â?¢Safety and tolerability of will be assessed by the number of patients with clinical adverse experiencesTimepoint: At the end of the study