Efficacy Of Dhatrayadi Ghrita Uttar Basti Combined With Latakaranja Ghanavati Orally In The Management Of Infertility Due To Anovulation An Exploratory Study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Follicular Development Ovarian Volume and Ovulation Assessed By Transvaginal Sonographic TVS Follicular Monitoring
研究概览
简要总结
Title of Study Efficacy of Dhatryadi Ghrita Uttar Basti combined with Latakaranja Ghanavati orally in the management of infertility due to anovulation An exploratory study
Background Anovulation is a major cause of female infertility contributing to about 25 to 30 percent of cases. Modern ovulation induction drugs may have side effects and limited success. Ayurveda offers non hormonal approaches like Uttar Basti and herbal formulations Dhatryadi Ghrita has uterine and hormonal modulatory action while Latakaranja is known for ovulation inducing and endocrine regulating properties
Objectives Primary Objective To evaluate the effect of Dhatryadi Ghrita Uttar Basti with Latakaranja Ghanavati orally on follicular development ovarian volume and ovulation assessed by transvaginal sonography
Secondary Objectives To assess effect on endometrial thickness hormonal profile menstrual pattern and conception status
Study Design Exploratory prospective single group clinical trial Sample size 30 women Duration 3 months with 1 month follow up
Intervention Dhatryadi Ghrita Uttar Basti 5 ml intrauterine for 5 days in 3 consecutive cycles after menstruation Latakaranja Ghanavati 500 mg twice daily orally for 12 days from day 3 of each cycle for 3 cycles
Inclusion Criteria Married women aged 20 to 35 years diagnosed with anovulatory infertility with normal uterine cavity and tubal patency partner with normal semen analysis
Exclusion Criteria Tubal blockage uterine anomalies endometriosis uncontrolled systemic or endocrine disorders acute pelvic infection severe illness pregnancy or use of other fertility drugs
Outcome Measures Primary Follicular development ovarian volume and ovulation Secondary Endometrial thickness hormonal profile menstrual regularity and conception
Statistical Analysis Paired T test or Wilcoxon signed rank test for within group changes. Repeated measures ANOVA or Friedman test for multiple observations. Significance level p less than 0.05
Ethical Considerations Study will be conducted after approval from Institutional Ethics Committee and registered with CTRI. Written informed consent will be taken from all participants
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
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Married Women aged 20 to 35 years in reproductive age group Diagnosed with anovulatory infertility confirmed by TVS Regular or irregular cycles with confirmed absence of ovulation Normal uterine cavity and tubal patency HSG or laparoscopy Partner with normal semen analysis Those patients who are eligible for Basti karma Provided written informed consent.
排除标准
- •Tubal blockage, uterine anomalies or endometriosis Uncontrolled endocrine and Metabolic disorders Acute PID Severe systemic illness diabetes hypertension hepatic renal disorders Tuberculosis Concurrent use of other fertility treatments or hormone therapy Pregnant or lactating women History of pelvic surgery affecting reproductive organs Those patients who are not eligible for Basti karma Patient on Metformin and other insuline sensitizing medication Rosiglitazone Pioglitazone Patient on Clomiphene citrate or estrogen modulators.
结局指标
主要结局
Follicular Development Ovarian Volume and Ovulation Assessed By Transvaginal Sonographic TVS Follicular Monitoring
时间窗: Within 2 weeks prior to treatment start and Day 2 3 after menses
次要结局
- Regularisation of the menstrual cycle Endometrial thickness(Hormonal profile changes)
研究者
Dr Ritiksha Jopale
All Inddia Institute of Ayurveda