Clinical Study to Evaluate the onset of Analgesic Effectiveness and Safety of Combination of Camylofin (50 mg) and Nonsteroidal Anti-Inflammatory Agent Mefenamic acid (250 mg) in Patients with Moderate to Severe Primary Dysmenorrhea
- Conditions
- Health Condition 1: Z538- Procedure and treatment not carried out for other reasons
- Registration Number
- CTRI/2020/12/030017
- Lead Sponsor
- Dr Pragya Pandey
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
1. Perimenopausal women above 18 years of age and below45years of age
2. Female patients with primary dysmenorrhea on the 1st or 2nd day of their current menstrual cycle
3. History of moderate to severe primary dysmenorrhea during four or more of the previous six menstrual cycles on10-point numeric rating scale
4. Patients willing to provide written informed consent
5. Female of childbearing potential must have a negative pregnancy test and be nonlactating at screening visit.
6. Patient is willing to abstain from alcohol consumption throughout the 12-hour Treatment Period
1. Female patients with a history of taking Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg or any other prescription-only and/or non-prescription analgesics, antispasmodics, antidepressants, or antipsychotic medication within the 4 weeks before study enrolment.
2. Patients who are determined as being the risk group for COVID-19.
3. Female patients on antacids, Antihistaminics, tricyclic antidepressants, phenothiazines, disopyramide, pethidine
4. Female patients taking Ace inhibitors, Asprin, Diuretics, Lithium, Methotrexate, Warfarin
5. Female patients with positive urine pregnancy test
6. Lactating female patients
7. Female patients with a history of irregular menstrual cycle in the last 6 months
8. Female patients with secondary dysmenorrhea (including the following etiologies: leiomyomata [fibroids], pelvic inflammatory disease, tubo-ovarian abscess, ovarian torsion, endometriosis) 9. Evidence of clinically relevant gynecological, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations
10. Physical examination suggesting a diagnosis of acute abdomen
11. Female patients with a history of upper gastrointestinal bleeding and/or active peptic ulcer
12. Females using an Intrauterine Contraceptive Device (IUCD) or currently using an oral contraceptive for less than 3 months, has been on a unstable dose within the last 3 months or has switched from one oral contraceptive to another within the last 3 months or intends to do so in the course of the study
13. Cognitive impairment, alcohol abuse, or psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments
14. History of hypersensitivity to study drug or any of its ingredients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To estimate time of onset of action of Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg tablet in patients with moderate to severe primary dysmenorrhea.Timepoint: 1. Day 1 to day 2
- Secondary Outcome Measures
Name Time Method 1. To evaluate the analgesic/pain relieving effect of Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg tablet in patients with moderate to severe primary dysmenorrhea. <br/ ><br>2. To assess the tolerability profile of the treatmentTimepoint: 1. Day 1 to day 2 <br/ ><br>2. Day 1 to day 2