None listed
Conditions
Interventions
Intervention1: Dysmegesic: Twice a day for 3 days during 2 consecutive menstrual cycles.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Shield Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with either â??Moderateâ?? or â??Severeâ?? dysmenorrhea severity assessment during Visit 1 2. Regular menstrual cycles for atleast 6 months 3. Subjects with body mass index of 18.50 to 30.00 kg/m2 (Both values inclusive) 4. Subjects who understand the nature and purpose of the study and who are willing to comply with study procedures. 5. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment 6. Must be willing and able to give informed consent and comply with the study procedures
Exclusion criteria
Exclusion criteria: 1. Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, salpingitis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, endometriosis, fibroids, obstructive endometrial polyps, cervical stenosis inflammatory bowel disease, irritable bowel syndrome). 2. Subjects suffering from mild primary dysmenorrhea. 3. Concomitant treatment with oral contraceptives, gonadotrophin releasing hormone agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs. 4. Recent history of abdominal surgery in the last 6 months. 5. Unevaluated gynaecological abnormalities inclusive of oncological diagnosis or suspicion (unexplained vaginal bleeding, cervical dysplasia) 6. Gross developmental defect or congenital abnormalities of uterus 7. Subjects with uncontrolled hypertension, diabetes or other uncontrolled co-morbidities. 8. Pregnant and nursing women or women who have given birth or had a miscarriage. 9. Women who have undergone hysterectomy. 10. Any history of major systemic illness and significant gastrointestinal & liver disorders, renal disorders, endocrine abnormalities, cardiovascular, respiratory, neuropsychiatric disorders or any other significant medical illness, in view of the investigator. 11. Subjects who are contemplating surgery/ pregnancy within 90 days after scheduled end of study treatment 12. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 13. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VMS & NRS Scores from Baseline to end of each cycleTimepoint: Day 0, Day 28, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in duration of time for pain reliefTimepoint: Day 0, Day 28, Day 56;Mean change in Menstrual Symptom Questionnaire (MSQ) scoreTimepoint: Day 0, Day 28, Day 56;Mean change inAbsenteeism from work or school/college, Use of any rescue medicationTimepoint: Day 0 Day 28, Day 56 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed