A Clinical Evaluation of Efficacy and Safety of White-free Capsule in patients suffering from leucorrhoea- An open labeled, single center, non-comparative, interventional, prospective, clinical study - NI

Jagat Pharma Pvt Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1.Women must agree to practice reliable contraception [Intrauterine device (IUD), Tubal sterilization, Vasectomy in male partner. Participants who use a hormonal contraceptive as one of their birth control methods should have the same method for a minimum of 3 months before the first dose of study drug. Acceptable hormonal methods (every hormonal method must be used with a barrier method like a condom, preferably a male condom). Oral contraceptives, Injectable progesterone, Contraceptive vaginal ring. Acceptable barrier methods (should be used with a hormonal method) Male or female condom with or without spermicide] for 30 days following treatment
•2.Presenting complaints of moderate grade Vaginal white discharge (moderate discharge, 3-4 days in a week, requires change of undergarments once daily), from last 15 days
•3.Not currently menstruating or expected to in the next 4 days
•4.Provide written informed consent before initiation of any study procedures and be available for all study visits

•1.Suffering from bacterial vaginosis (Purulent discharge with fishy smell) as per InvestigatorÃ¢â?¬•s opinion
•2.Women who had used prescribed medications (oral or topical antibiotics including metronidazole, clindamycin, tinidazole etc. Anti-fungal drugs including clotrimazole and ketoconazole etc.) for vaginal complaints in the past 2 weeks.
•3.Including, but not limited to, ongoing or active infection, active liver, kidney or autoimmune diseases, uncontrolled diabetes, hypertension, cardiac diseases.
•4.Subjects with known history of hepatitis B and/ or C
•5.Patients on Oral Contraceptive Pills for last one month
•6.Patients with IUCD for last one month
•7.Known case of venereal disease
•8.History of significant per vaginal bleeding over the last 1 month
•9.Prolapsed of uterus
•10.Known case of malignancy in the internal genital parts and known case of any malignancy
•11.Allergy to any constituent of white free capsule
•12.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria

发起方

Jagat Pharma Pvt Ltd