CTRI/2022/12/048147招募中2 期
Evaluation of efficacy and safety of combination therapy of VAMHA and MYRHA in the management of PCOS â?? An Open labeled, Randomized, Multi-center, Comparative Prospective, Clinical study
Gynoveda Femtech Pvt. Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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 diagnosed with PCOS by presence of two of the of the three Rotterdam criteria: Oligomenorrhoea, anovulation; Hyperandrogenism (high total testosterone levels); and the observation of polycystic ovaries by USG.
- •2. Subjects not immediately (at the time of screening) requiring Hormone therapy for the treatment of PCOS
- •3. Subjects who were willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.
排除标准
- •1. Subjects with excessive menstrual bleeding
- •2. Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids, endometriosis, cervical erosion (as diagnosed by USG lower abdomen and pelvis).
- •3. Subjects having clinical and/or biochemical signs of severe hyperandrogenism
- •4. Subjects having systematic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, Hirsutism, Addisonâ??s disease and/or Cushing disease.
- •5. Subjects with uncontrolled Hyper or Hypothyroidism
- •6. Subjects with raised Prolactin levels
- •7. Subjects with one year of history of child birth
- •8. History of genitor-urinary surgery, and/or other major medical or surgical diseases; which can affect or related with study outcomes.
- •9. Use of corticosteroids or hormones or hormonal drugs within last 1 months of screening visit.
- •10. Use of any other investigational drug within 1 month prior to screening visit.
- •11. Subjects having known hypersensitivity to any ingredient of the study drug.
- •12. Any other condition which in the opinion of investigator would have placed the subject at risk or would have influenced the conduct of study or interpretation of results
研究者
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