A Study to evaluate the Efficacy and safety of Grace Hing Asafoetida 15mg Capsules in PrimaryDysmenorrhea.
- Conditions
- Health Condition 1: N944- Primary dysmenorrhea
- Registration Number
- CTRI/2022/05/042651
- Lead Sponsor
- TRA GRACE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference between the reported Visual <br/ ><br>Analogue Scale before and after the <br/ ><br>treatment(Grace hing capsule-15mg). Each <br/ ><br>participant will rank the severity of her <br/ ><br>dysmenorrhea symptoms before and after the <br/ ><br>treatment use on the VAS scale from 0 to 100, <br/ ><br>where 0 determines- No pain and 100 <br/ ><br>determines Very painful. Then, the difference <br/ ><br>between the two measurements will be <br/ ><br>calculatedTimepoint: 3 days before the beginning of the menstrual <br/ ><br>period and up to three days after termination of <br/ ><br>the menstrual period.
- Secondary Outcome Measures
Name Time Method To assess the associated systemic symptoms <br/ ><br>Score of DysmenorrheaTimepoint: 3 days before the beginning of the menstrual <br/ ><br>period and up to three days after termination of <br/ ><br>the menstrual period;To assess the improvement in the quality of life <br/ ><br>determined by SF- 36 health survey <br/ ><br>questionnaireTimepoint: 3 days before the beginning of the menstrual <br/ ><br>period and up to three days after termination of <br/ ><br>the menstrual period;To assess the PBLAC score for menstrual blood <br/ ><br>loss.Timepoint: During the Menstural Period for 5 days