Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
Intervention1: Grace Hing (Hing oil 15mg) HPMC Capsules: Each HMPC Capsules contains:
Hing Oil- 15 mg. Take
liquid filled vegetarian capsule
twice daily, along with the meal
Control Intervention1: NA
Sponsors
NUTRA GRACE
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy female patients between 18 â?? 35 years of age. 2. Patient has a history of Over-the-Counter (OTC) analgesic use for treatment of primary dysmenorrhea; 3. Patient has a history of regular menstrual cycles that typically occurs between every 21 to 35 days 4. Patients having a self-reported history of primary dysmenorrhea with other causes of dysmenorrhea having been excluded. 5. Patient who normally experiences pain relief from the analgesic medications in taken.
Exclusion criteria
Exclusion criteria: 1. Patient has a known allergy to any of the excipients in any of the study medication products. 2. GI Disorders hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure. 3.Patient has an ongoing sexually transmitted disease or has abnormal vaginal discharge. 4. Patient has a current or past history of severe gastritis, gastrointestinal bleeding or ulceration. 5. Patient has a current or past history of one or more of the following conditions: secondary dysmenorrhea, pelvic inflammatory disease, urinary tract infection, adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator would impact patient safety and/or the study data. 6. patient requires prescription Analgesics, narcotic, non-NSAID or has routinely taken OTC medications in excess of label recommended instructions for control of dysmenorrhea symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference between the reported Visual Analogue Scale before and after the treatment(Grace hing capsule-15mg). Each participant will rank the severity of her dysmenorrhea symptoms before and after the treatment use on the VAS scale from 0 to 100, where 0 determines- "No pain" and 100 determines "Very painful". Then, the difference between the two measurements will be calculatedTimepoint: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the associated systemic symptoms Score of DysmenorrheaTimepoint: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period;To assess the improvement in the quality of life determined by SF- 36 health survey questionnaireTimepoint: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period;To assess the PBLAC score for menstrual blood loss.Timepoint: During the Menstural Period for 5 days | — |
Countries
India
Contacts
Public ContactMr Sunil Gupta
Pharexcel Consulting Private Limited
Outcome results
None listed