Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Single (unmarried), young adult females between 20 and 24 years of age. Subjects having regular menstrual cycles in the interval of 21–35 days and bleeding duration of 3-7 days. Subjects suffering from pain during menstruation for more than 2 consecutive menstrual cycles. Lower abdominal and pelvic pain associated with onset of menses. Onset of pain within 6–12 hours after onset of menses and pain lasting for 9–72 hours. Subjects of Grade 1, 2 and 3 on the Verbal Multidimensional Scoring (VMS) System.
Exclusion criteria
Exclusion criteria: Female subjects with known history of Secondary Dysmenorrhea, Pelvic pathology, endometriosis, tubercular endometritis, polycystic ovarian syndrome. Female subjects with known history of thyroid, pituitary and hypothalamic abnormalities, general diseases like tuberculosis, nephritis, diabetes and heart diseases. History of any other surgical and neurological condition or surgery resulting in Dysmenorrhea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in spasmodic lower abdominal pain as assessed in VMSS. Timepoint: Mentruation related spasmodic lower abdominal pain relief within 3 days of administration of trial drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in Associated Symptoms of Primary Dysmenorrhea as assessed in CMSS.Timepoint: Relief within 3 days of administration of trial drug. | — |
Countries
India
Contacts
SDMIAH BANGALORE