A Randomised Comparative Clinical Study To Evaluate The Efficacy Of Nagakeshara(Messua Ferrae Linn. ) And Its Market Substitute Surpunnaga(Ochrocarpus Longifolius Benth and Hook) In The Management Of Asragdara Wsr To Abnormal Uterine Bleeding.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in symptoms of Asragdara
研究概览
简要总结
Due to scarcity and unavailability of Nagakeshara and lack of awareness, fresh stamens and buds of other plants are used instead of Nagakesharastamens. Nagakeshara is being substituted by Surpunnaga in the market. This study aims at the comparative evaluation of Raktastambhana karma of Surpunnaga with Nagakeshara and hence to prove its effect in asragdara clinically.
Aim: To compare the efficacy of Nagakeshara and its market substitute Surpunnaga in the management of asragdara wsr to abnormal uterine bleeding*.*
Objectives: 1. Pharmacognostical and phytochemical evaluation of Nagakeshara and its Market substitute *Surpunnaga.*2. To compare the efficacy of Nagakeshara and its Market substitute Surpunnaga on the Management of symptoms of Asragdara. 3. To compare the efficacy of Nagakeshara and its Market substitute Surpunnaga on the Management of scale of PBLAC scoring system.
Null Hypothesis [Ho]-There is no difference in the efficacy of Nagakeshara and its Market substitute Surpunnaga in the Management of asragdara.
Alternative Hypothesis [HA] – There is a difference in the efficacy of Nagakeshara and its Market substitute Surpunnaga in the Management of asragdara.
Study Design : Study type : Interventional , A Single blind Randomised comparative clinical study. Phase of clinical trial : phase 2 , Sample size: 60 patients will be registered and they will be divided into group A and group B. Each group will have 30 patients, Study duration: 18 months.
The statistical analysis of the research will be done using the appropriate statistical tests and with a significance level of <0.05 and 80% statistical power.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects gave the complaint of Asragdara with any two of the following features for 2 consecutive cycles.
- •Heavy menstrual bleeding (amount Greater than 80ml) (Amount more than 80 ml will be assessed by pictorial blood loss assessment chart scoring more than 100 points.) Prolonged menstrual bleeding Greater than 7 days.
- •Inter menstrual bleeding with/without heavy flow or Frequent menstrual cycle less than 24days.
- •Features different from normal menstrual blood, pain, burning sensation, body ache.
排除标准
- •Patients with chronic of systemic illness (Congestive cardiac failure, Hypertension, cirrhosis of liver, Tuberculosis endometritis, severe anemia, chronic renal disease, Insulin dependent diabetes mellitus etc.).
- •Patients using Intrauterine contraceptive device or oral contraceptive pills (latrogenic).
- •Patients with uterine and pelvic pathology (Fibroid size Greater than 2 cm, endometriosis, adenomyosis, polyp, high grade cervical erosion, endometrial thickness Greater than 20mm etc.).
- •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 hematological disorders (Leukemia, Thrombocytopenic Purpura).
- •Postmenopausal bleeding.
- •Sexually transmitted infections/Genital tract infections.
结局指标
主要结局
Change in symptoms of Asragdara
时间窗: Change in the symptoms of Asragdara from baseline to 2 months of period.
次要结局
- Changes in PBLAC scoring system.(Changes in PBLAC scoring system from baseline to 2 months of period.)
研究者
Disha Parmar
National Institute Of Ayurved