An Open Labelled Single Arm Clinical Study To evaluate the Efficacy and safety of Grace Hing (Hing oil 15mg) HPMC Capsules in the Treatment of Primary Dysmenorrhea

TRA GRACE0 个研究点目标入组 15 人开始时间: 待定最近更新: 2023年1月9日

试验速览

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•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.

发起方

TRA GRACE