CTRI/2018/03/012481已完成3 期
Single Arm study to evaluate Efficacy and Safety of Oral Tracnil in patients of PCOS with Associated symptoms of Mild to Moderate Acne and Hirsutism
Curatio Health Care I Pvt Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Female patients between age 18 to 45 years of age
- •2.Presence of PCOS with associated symptoms of mild to moderate acne and hirsutism
- •3.Patients with BMI >28 or Waist Hip Ratio >0.9
- •4.Patients with 5-50 Non-inflammatory facial lesions, except in the nose region (comedo closed and open comedo -degree 1) and/or 10 to 50 inflammatory facial lesions, except in the nose region (papule and pustule -degree 2)
- •5.Patients with Ferriman-Gallwey hirsutism score 7 to 20, with Mild to moderate Acne
- •6.Euthyroid Status
- •7.Patient must not be pregnant, nursing or intend to become pregnant during the study
- •8.Patient must agree to practice a medically acceptable form of birth control.
- •9.Ability to understand and consent to participate in this clinical study, expressed by signing the consent form
- •10.Patient willing to participate by providing written informed consent
排除标准
- •1.Any finding of clinical observation (clinical assessment / physical) that is interpreted by the investigator as a risk to safety or which may interfere with the effectiveness of the treatment and research of the participants in the clinical trial;
- •2.Any laboratory examination found that the investigator considers as safety risk or that may interfere with the effectiveness of the treatment and research of the participants in the clinical trial;
- •3.Patients already taking or requiring Hormonal Treatment during study duration
- •4.Other condition causing ovulatory disorders or androgen excess as hyperprolactinaemia, hypothyroidism, adrenal hyperplasia and Cushingâ??s syndrome
- •5.Known hypersensitivity to the drug components used during the study;
- •6.Patients with Uncontrolled or poorly controlled Diabetes Mellitus (HbA1C >6.5)
- •7.Patients with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding
- •8.Patients in the reproductive age who do not agree touse acceptable contraception [intrauterinedevice (IUD), barrier methods and tubal ligation]; other than surgically sterile (bilateral oophorectomy or hysterectomy) or sexual abstinence or who have not yet initiated sexual activity;
- •9.Presence of dermatoses related to diabetes mellitus (plantar ulcer, necrobiosis lipoid, annular granuloma, dermatophytosis, deep mycoses, bacterial infections, opportunistic infections)
- •10.Presence of dermatological diseases in the test area (face): vitiligo, psoriasis, atopic dermatitis
- •11.Participant with cyst or lump in the face region; other diseases or medications, according to the investigator, that would interfere directly in the results of the study or jeopardize the health of the participant.
研究者
相似试验
招募中
2 期
Single arm study to evaluate the efficacy and safety of Relugolix in adenomyosisJPRN-jRCTs031220684Hirota Yasushi20
已完成
2 期
R-evolution trialHepatocellular carcinomaChemotherapyJPRN-jRCTs031190236Ogasawara Sadahisa30
已完成
不适用
A single arm study to assess the efficacy and safety of high dose intake of food containing aged garlic extract on fatigueHealthy volunteerJPRN-UMIN000029109Momoya Co., Ltd.10
已完成
3 期
Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trialJPRN-UMIN000039474ational Cerebral and Cardiovascular Center25
招募中
不适用
A single arm study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy for obese patients with diabetes mellitus.diabetes mellitusJPRN-UMIN000035768ational Center for Global Health and Medicine10