Multicentric, open-labeled, randomized, parallel-group, active-controlled phase III clinical trial comparing fixed dose combination of Miconazole Nitrate 100 mg + Neomycin Sulphate 20 mg + Tinidazole 500 mg vaginal tablets with Miconazole Nitrate 100 mg vaginal pessary in patients with vaginitis

Centaur Pharmaceuticals Pvt Ltd0 个研究点目标入组 32 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•1.All the patients with duly filled Informed Consent Forms [ICF].
•2.Female patient above the age of 18 years.
•3.Clinically diagnosed vaginitis, presence of any four following seven symptoms:
•Vaginal discharge
•Frequent urination
•Burning micturition
•Irritation
•Foul smell of discharge
•Dyspareunia
•4.Vaginal smear positive for bacteria/ fungal infection/ infestation
•5.Patient with negative urine pregnancy test.
•6.Patient between 5th to 25th days of menstrual cycle.
•7.Female of childbearing age on accepted mode of contraception such as oral contraceptive tablets or Copper-t [CuT]

•1.Known sensitivity to azoles derivatives and amino glycosides.
•2.Women who will be the under treatment during the study period for cervical intra epithelial neoplasia or cervical carcinoma.
•3.Pregnancy and lactation.
•4.Women with gynaecological condition that contraindicated the use of vaginal tablet.
•5.Women who have used any other local or systemic antibacterial, antiprotozoal, antifungal agent in the last two weeks.
•6.Patients who have been tested positive for HIV-I and HIV-II, HBV and VDRL.
•7.Patients using spermicides, diaphragm and oral contraceptives.
•8.Patients whose routing urine analysis has unveiled presence of gonococci. [gonococcal infection]
•9.Women with metabolic or immunological disorder.
•10.Dysfunctional uterine bleeding.
•11.Patient consuming alcohol or chronic alcoholic patient.
•12.Patients with concomitant disease like Pulmonary Kochâ??s, Bronchial asthma, Diabetes Mellitus, Epilepsy, CCF etc.
•13.Patient with concomitant medication which according to the investigator can alter the metabolism and efficacy of the test medication.

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