A comparative clinical study of NÄgakesara CÅ«rnÌ£a and KutakÄ« CÅ«rnÌ£a in the management of AsrÌ£gdara with special reference to Dysfunctional Uterine Bleeding.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy (reduction in complaints of DUB)
研究概览
简要总结
Dysfunctional uterine bleeding occurs most commonly at the extremes of reproductive age (20% of cases occur in adolescence and 40% in patients over age 40).Various treatments are available in modern medicine such as hormones therapy, anti-fibrinolytic agents, anti-prostaglandins etc. but have not proved their definite efficacy in spite of high cost and side effects. Although the medical therapy is generally used first, excessive menstrual bleeding accounts for two third of all hysterectomies.So, there is great scope of research to find out safe, potent, cost effective remedy from Ä€yurvedaby addressing the root of the problem thereby improving the quality of life of women. This study will be carried out to evaluate the efficacy of NÄgakesara CÅ«rnÌ£a and KutakÄ« CÅ«rnÌ£a in AsrÌ£gdara and to know about the possible aetiology of *Asrigdara.*Patients will be selected from O.P.D. and I.P.D. of PrasutiTantra and StriRoga Department of N.I.A., Jaipur as per criteria. Written voluntary informed consent will be taken from each patient before starting the trial. The clinical study will be conducted on minimum hundred clinically diagnosed patients of AsrÌ£gdara and randomly divided into two groups. An observational study about the NidÄna of AsrÌ£gdara will also be carried out by making a questionnaire among minimum two hundred patients. All the patients registered for the present trial will be assessed on the basis of subjective parameters, objective parameters and laboratory investigations and Pictorial blood loss assessment chart (PBLAC) and SF-36 questionnaire for quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- Female
入选标准
- •Patients ready to participate in the clinical trial.
- •Patients diagnosed as dysfunctional uterine bleeding.
- •Excessive menstrual bleeding (amount >80 ml) or Prolonged menstrual bleeding (>7 days) with or without heavy flow or Frequent menstrual cycle (interval< 21 days) 4) Patients presenting with inter-menstrual bleeding with or without heavy flow for 2 consecutive cycles.
排除标准
- •Patients with chronic systemic illness (Congestive cardiac failure, Hypertension, cirrhosis of liver, Tuberculosis endometritis, severe anaemia, chronic renal disease, Insulin dependent diabetes mellitus etc.).
- •Patients using Intrauterine contraceptive device or oral contraceptive pills (Iatrogenic).
- •Patients with uterine and pelvic pathology (Fibroid size >2 cm, endometriosis, adenomyosis, polyp, high grade cervical erosion, endometrial thickness >20 mm etc.).
- •Congenital malformations of uterus(Septate uterus, double uterus).
- •Benign and malignant growth.
- •Thyroid dysfunction (endocrinal disorders).
- •Patients having bleeding due to abortion, ectopic pregnancy, during puerperium.
- •Patients taking Anti-coagulation therapy and having haematological disorders (Leukemia, Thrombocytopenic Purpura).
- •Postmenopausal bleeding.
- •Sexually transmitted infections/Genital tract infections.
结局指标
主要结局
Efficacy (reduction in complaints of DUB)
时间窗: 2 months
次要结局
- Any adverse event reported voluntarily, observed or enquired(3 months)
