CTRI/2011/12/002188
Recruiting
Phase 4
Comparative Efficacy, Safety and Cost Effectiveness of Lornoxicam with Ibuprofen in Patient with Primary Dysmenorrhoea : A Randomized, Double-Blind, Active-Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: N944- Primary dysmenorrheaHealth Condition 2: null- primary dysmenorrhoea
- Sponsor
- Government Medical College Bhavnagar
- Enrollment
- 75
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •?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
Outcomes
Primary Outcomes
Not specified
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