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.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Number of subjects achieving regular frequency of menstrual cycle
研究概览
简要总结
It is a randomized,comparative, double blind, multi-centric prospective, interventional clinicalstudy to evaluate efficacy and safety of AHPL/AYLIQ/0717 syrup in comparisonwith Marketed formulation in participants suffering from menstrualirregularities. Study will be conducted at 4 to 5 centers in India. Subjects willbe randomly assigned to AHPL/AYLIQ/0717 syrup group or marketed formulationsyrup group in 1: 1 ratio. Subjects will be asked to take given medication in adose of 3 teaspoons full twice daily orally after meals with water for 120 days.The primary objective of the study will be to assess number of subjectsachieving regular frequency of menstrual cycle. Secondary objectives of thestudy will be to assess number of subjects achieving regular menstrual bleeding days, changes inamount of menstrual bleeding, abdominal pain (spasm) on VAS, changesin symptoms associated with irregular menstruation, frequency of use of NSAIDsand / or antispasmodic drugs as rescue medications, global assessment foroverall change by physician and by patient, global assessment of tolerabilityof study drugs and changes in safety laboratory parameters on Day 0, Day 30,Day 60, Day 90 and Day 120.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients diagnosed with irregular with non-organic causes for last 3 months.
- •Females willing to provide written informed consent and ready to comply with study protocol.
排除标准
- •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).
- •Subjects having clinical signs of hyper-andronism.
- •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.
- •Subjects with known HIV, cancer, hepatitis B and C conditions.
- •Subjects with one year of history of delivery or abortion.
- •History of genitor-urinary surgery, and or other major medical or surgical diseases; which can affect or related with study outcomes.
- •Pregnant and lactating women.
- •Women of child bearing age, not willing to follow adequate contraceptive methods excluding oral contraceptive pills.
- •Use of corticosteroids or hormones or hormonal drugs within last 1 month from screening visit.
- •Use of any other investigational drug within 1 month prior to screening visit.
- •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.
- •Known hypersensitivity to ingredients used in study drugs.
- •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.
结局指标
主要结局
Number of subjects achieving regular frequency of menstrual cycle
时间窗: Day 0, Day 30, Day 60, Day 90 and Day 120.
次要结局
- 1) Number of subjects achieving regular menstrual bleeding days(2) Changes in amount of menstrual bleeding)