Health Condition 1: null- Primary Dysmenorrhea
Conditions
Interventions
Intervention1: Drotaverine hydrochloride with Mefenamic acid: Drotaverine hydrochloride (80mg) and mefenamic acid (250mg) t.i.d orally for three days in the investigational group
Control Intervention1
Sponsors
Walter Bushnell Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients with regular menstruation (28 ± 7 day cycle) Patients with history of primary dysmenorrhoea Patients ready to follow-up
Exclusion criteria
Exclusion criteria: Failure to meet all inclusion criteria Causes of secondary dysmenorrhea including endometriosis, pelvic inflammatory disease, adenomyosis, fibroids (myomas), endometrial polyps, cervical stenosis (after uterine or cervical surgery), functional ovarian cysts, benign or malignant tumors of ovary, bowel or bladder, or other site, Inflammatory bowel disease Pregnant and lactating women Any pelvic abnormality on physical examination including infection or inflammatory process Premenstrual syndrome (PMS), infertility, heavy menstrual flow or irregular cycles, dyspareunia Any previous clinical history of gastroduodenal ulcer, gastrointestinal bleeding, or gastroduodenal perforation Concomitant use of medications that are known to increase the likelihood of upper gastrointestinal adverse events (e.g. corticosteroids and anticoagulants) Presence of serious co-morbidity, such as cardiovascular disease, cerebrovascular disease, renal or hepatic impairment, history of venous disease, diabetes, or hypertension Patients with history of hypersensitivity to NSAID and/or drotaverine Women will also be excluded if they had used an intrauterine device or oral contraceptives within six months prior to the study and had received NSAIDs or analgesics within 48 h prior to study entry Patients participating in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of pain relief at different time intervals i.e 15, 30 minutes, 1, 2, 4, 8, 12, 24 and 48 hours after the first dose of study medication Total area under pain relief (PR) score up to 2, 4 and 8 hours (TOPAR/2, TOPAR/4 and TOPAR/8)Timepoint: Assessment of pain relief at different time intervals i.e 15, 30 minutes, 1, 2, 4, 8, 12, 24 and 48 hours after the first dose of study medication Total area under pain relief (PR) score up to 2, 4 and 8 hours (TOPAR/2, TOPAR/4 and TOPAR/8) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Intensity Difference Sum of Pain Intensity Difference over 2, 4 and 8 hours Peak PID over 2, 4 and 8 h Peak PR over 2, 4 and 8 h Total study drug consumption Patientâ??s and investigatorâ??s global evaluation of the efficacyTimepoint: Pain Intensity Difference Sum of Pain Intensity Difference over 2, 4 and 8 hours Peak PID over 2, 4 and 8 h Peak PR over 2, 4 and 8 h Total study drug consumption Patientâ??s and investigatorâ??s global evaluation of the efficacy | — |
Countries
India
Contacts
Public ContactDr J B Sharma
All India Institute of Medical sciences
Outcome results
None listed