An Analytical and Comparative Study Between Shatavari and Nirgundi in Anovulation and Endometrial Expression Profiling
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Based on Subjective and objective parameters and laboratory investigations
研究概览
简要总结
Anovulation is the failure of the ovary to produce an ovum. Technically anovulation refers to the absence of ovulation; however, some women ovulate infrequently. Anovulation or ovulatory dysfunction is most common cause of infertility which is about 30-40%. as per FIGO and, it is also possible cause of PCOS (Poly Cystic Ovarian Syndrome) due to hormonal imbalance. Hormones i.e. LH, FSH, oestrogen, Progesterone, prolactin, AMH, TSH and hypothalamo-pituitary ovarian axis play an important role in a complex procedure of ovulation but any alteration or imbalance between all these may lead to anovulation. The clinical features of anovulation resemble with symptoms of ‘beejadushti’ i.e. beejopaghata (destruction of sperm or ovum) and pushpopaghata (destruction of menstrual blood or ovum). In Ayurvedic texts, the information related to anovulation is found in scattered form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Married women Patients with 2 consecutive anovulatory cycles.
排除标准
- •Unmarried patients Patient having like organic pelvic pathology, benign and malignant tumours (Vulval, vaginal, rectal, cervical, uterine, ovarian), PID, congenital anomalies of genital tract and different type of infections of genital tract.
- •Patient suffering from chronic systemic diseases like uncontrolled hypertension, uncontrolled diabetes or any disorders influencing the general physical health and ultimately influencing menses.
- •Patients using IUCD and OCPs or injectable contraceptives & others.
- •Patients diagnosed with venereal diseases like syphilis, Gonorrhoea, HIV, HBsAg etc.
- •Patient is on chemotherapy/radiotherapy for malignant condition of the breast or any other organ.
结局指标
主要结局
Based on Subjective and objective parameters and laboratory investigations
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
A Subjective Criteria
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Characteristics of menstruation
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Intermenstrual period
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Duration of menstrual bleeding
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Amount of blood loss
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
B Objective criteria
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Size and maturity of follicles/ovulation
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Viscosity of cervical mucus
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Hormonal profile
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum Progesterone (on D 8 & 21),
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum LH (midcycle daily)
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum FSH (D2/3)
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum Estradiol (D2/3)
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum Prolactin
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum Testosterone
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum AMH
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Serum Cortisol (morning 7-8 am)
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Biochemical characterization of endometrium.
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
Applebaum’s Uterine Scoring System for Reproduction (USSR)
时间窗: Total Four follow ups will be done at the regular interval of 1 month or as per her duration and interval of menstrual cycle
次要结局
- Ovulation will be observed in the patients of anovulatory cycle(3 follow ups will be done with medication at the regular interval of one month or duration & interval of her cycle & last follow up will be done without medication after 3rd cycle of uttara basti)
研究者
Dr Powar Padmja Parashram
Banaras Hindu University