CTRI/2022/09/045828已完成2 期
A randomized, comparative, double blind, multi-centric, prospective, interventional clinical study to evaluate efficacy and safety of ‘AHPL/AYLIQ/0717 syrup’ in comparison with Marketed formulation in participants suffering from menstrual irregularities. - NI
Ari Healthcare Pvt Ltd0 个研究点目标入组 89 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
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 irregular with non-organic causes for last 3 months.
- •2) Females willing to provide written informed consent and ready to comply with study protocol.
排除标准
- •1) Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids, endometriosis, cervical erosion and PCOS (as diagnosed by USG). 2) Subjects having clinical signs of hyper-andronism. 3) Subjects having known systematic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, hypothyroidism, hyperthyroidism, hirsutism, Addison disease and or Cushing disease. 4) Subjects with known HIV, cancer, hepatitis B and C conditions. 5) Subjects with one year of history of delivery or abortion. 6) History of genitor-urinary surgery, and or other major medical or surgical diseases; which can affect or related with study outcomes. 7) Pregnant and lactating women. 8) Women of child bearing age, not willing to follow adequate contraceptive methods excluding oral contraceptive pills. 9) Use of corticosteroids or hormones or hormonal drugs within last 1 month from screening visit. 10) Use of any other investigational drug within 1 month prior to screening visit. 11) Subject who are not willing to refrain from the use of any Ayurvedic, Homeopathy, Unani, Siddha medicine, and Nutraceutical and food supplements for menstrual irregularity during trial duration. 12) Known hypersensitivity to ingredients used in study drugs. 13) Other conditions, which in the opinion of investigators, make patient unsuitable for enrolment or could interfere with her participation in, and completion of the study.
研究者
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