An Open-Label, Single-Arm, Multicentric, Prospective Clinical Study to Evaluate Efficacy and Safety of Gynoveda Ayurvedic Formulations (Poshini along with Upaja and Rutuja) in Female Infertility
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
- 5
研究概览
简要总结
It is an open-label, single-arm, multicentric, prospective clinical study to evaluate efficacy and safety of Gynoveda Ayurvedic Formulations (Poshini along with Upaja and Rutuja) in Female Infertility. The study will be carried out at 10 to 12 centers in India. Subjects will be instructed to take Tab. Poshini and Tab. Upaja at a dose of 2 tablets each, twice daily, orally after meals with water, for a duration of 120 days. Additionally, in participants where timely ovulation (egg rupture) does not occur (as identified in the previous menstrual cycle) Tab. Rutuja will be administered at a dose of 2 tablets twice daily from Day 6 to Day 16 of each menstrual cycle (only if ovulation is absent or suboptimal, as confirmed by follicular monitoring). If a subject achieves consecutive three ovulations during the course of the study, all study medications (Poshini, Upaja, and Rutuja) will be discontinued immediately. Primary objective will be to assess number of participants achieving Ovulation based on follicular study. The secondary objectives of the study will be to assess largest Developing Follicle (Dominant follicle), change in endometrial thickness, number and percentage of participants who report conception (A positive test of serum Beta hCG), change in serum AMH, global assessment for overall change as assessed by participants and investigator, tolerability of study medications as assessed by participants and investigator and safety evaluation by assessing adverse events, clinical symptoms, signs, vitals and laboratory tests on Screening Visit (Day up to 5 If needed), Baseline Visit (Day 0), Visit I (Day 30 + 5 days), Visit II (Day 60 + 5 days), Visit III (Day 90 + 5 days), Visit IV (Day 120 + 5days).
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 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Married female participants diagnosed with primary or secondary infertility
- •Menstrual cycle- 21 to 35 days
- •History of miscarriage or habitual abortion, provided it occurred more than one year prior to enrolment
- •Acceptable ultrasound (USG) findings: Simple cysts less than 2 cm, hemorrhagic cysts less than 2 cm, follicular cysts less than 2 cm, intramural and sub serosal fibroids less than 2 cm in size.
- •Serum AMH levels between 1to 4 ng per mL with baseline ovulation may be positive or negative
- •Ability to have regular intercourse during the ovulation induction phase of the study.
排除标准
- •Current pregnancy
- •Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids greater than 2 cm, endometriosis, cervical erosion, Ovarian cysts greater than 2 cm, (as diagnosed by USG lower abdomen and pelvis).
- •All submucosal fibroids to be excluded from the study
- •Pelvic inflammatory disease (PID), miscarriage within the last 1 year
- •History of positive for sexually transmitted infections: HIV, Hepatitis A, B, or C
- •Liver cirrhosis, chronic kidney disease, or other severe systemic illnesses
- •TORCH positive
- •All cases of hyperprolactinemia, whether controlled with medicine or not, will be excluded.
- •Known causes of infertility (e.g., tubal blockage, male factor infertility, PCOD, endometriosis, etc.
- •Current use of hormonal treatment or ovulation induction agents
- •Other known cause of infertility: endometriosis, tubal factor, uterine abnormalities
- •Uncorrected thyroid disease
- •Any systemic illness or condition affecting fertility
- •Medical conditions in which avoiding pregnancy is recommended until under improved control: poorly controlled Type 1 or Type 2 diabetes, poorly controlled hypertension.
- •Use of medications known to affect reproductive function or metabolism or that are an absolute contraindication during pregnancy within the past month.
- •Participants not willing to attempt conception during the study period
- •Use of any other investigational drug within 1 month prior to screening visit.
- •Subjects having known hypersensitivity to any ingredient of the study drug.
- •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
Dr Amit Apparao Khamitkar
Shripad Multi Specialty Hospital