Clinical study to evaluate efficacy and safety of TULHA tablets in participants suffering from Delayed Periods (Oligomenorrhea)- An Open Label, Prospective, Interventional, Multi-center, Study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
研究概览
简要总结
It is an open label, prospective, interventional, multi-center, clinical study to evaluate efficacy and safety of TULHA tablets in participants suffering from Delayed Periods (Oligomenorrhea). The study will be conducted at 10 to 12 centers in India. Subjects will be asked to take 2 tablets of TULHA two times daily after meals with water for 120 days. Primary objective of the study will be to assess number of subjects achieving regular frequency of menstrual cycle. The secondary objectives of the study will be to assess changes in number of bleeding days, amount of menstrual bleeding, number of subjects achieving ovulation during the study period, change in symptoms associated with delayed periods, change in weight and BMI, change in skin glow, spontaneous pregnancy, global assessment for overall change by subject and investigator, tolerability of study medications as assessed by participants and investigator, safety evaluation by assessing adverse events, clinical symptoms, signs, vitals and laboratory tests on Baseline visit, Day 30, Day 60, Day 90 and Day 120
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female (married and unmarried) patients diagnosed with delayed periods (35 to 90 days) since 2 cycles
- •Female with natural periods without OC or hormonal pills
- •Subjects with serum AMH 1 to 4 ng per ml
- •Subjects with normal Serum FSH level
- •Subjects willing to provide written informed consent and ready to comply with the study protocol.
- •Note: Subjects with Intramural and subserosal fibroids less than 2 cm and ovarian cysts less than 2 cm in size will be included.
排除标准
- •Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids greater than 2 cm, endometriosis, chocolate cysts, cervical erosion and PCOD (as diagnosed by USG).
- •Subjects with heavy and extended (10 days) bleeding
- •Subjects with submucosal fibroids
- •Subjects having hyperprolactinemia.
- •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.
- •Known cases of autoimmune and chronic debilitating disease
- •Subjects on anti-depressant medications
- •Pregnant and lactating women.
- •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.
- •Known hypersensitivity to ingredients used in study drug.
- •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.
研究者
Dr Avinash Deore
Shree Sai Ayurvedic Panchakarma Rugnalaya