A comparative clinical study to evaluate the efficacy of Kuberaksha vati and Dashmoola Taila Matra Basti in the management of Udavartini yonivyapad with special reference to primary dysmenorrhea.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.To evaluate the efficacy of Kuberaksha vati and Dashmoola taila matra basti in the management of udavartini yonivyapad.
研究概览
简要总结
This is a Randomised, comparative clinical study Phase 2 Parallel group trial. Comparing the efficacy of Kuberaksha vati and Dashmoola taila Matra Basti in cases of Udavartini Yonivyapad for 3 months in 40 patients. The patient fulfilling the clinical criteria for diagnosis of Udavartini Yonivyapad will be randomly selected from OPD/IPD of state Ayurvedic College and Hospital, Lucknow and referred cases from other hospitals. A careful history, physical examination and necessary investigation will be performed. Further patient divided into two groups, Group-A- In this group patients will be treated with Kuberaksha vati orally 2 tabs BD (250 mg each) with lukewarm water after meal for the period of 3 months. Group-B- In this group patients will be treated with Kuberaksha vati orally 2 tabs BD (250 mg each) with lukewarm water after meal for the period of 3 months along with Dashmoola taila Matra Basti per rectal in the dose of 60 ml for the period of 7 days before the expected date of menses. Follow up period will be 30 days after the completion of trial.
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
- 16.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.female patient of age 16 to 35 years.
- •2.Patient suffering from pain during mensuration for more than 3 consecutive cycle.
- •3.Patient coming with chief complaint of pain during menses with or without associated symptoms.
- •Patient willing and able to participate in study.
排除标准
- •1.Female patients age below 16 years and above 35 years of age.
- •2.Patients with any identifiable pelvic pathology like fibroids, adenomyosis, endometriosis, PID, UTI etc.
- •3.Patients using IUD /oral contraceptive pills.
- •4.Patient have H/O hypothyroidism and hyperthyroidism with DUB .
- •5.Patients with systemic disorders like Tuberculosis, Hypertension, Diabetes mellitus, anemia etc.
- •6.Patient not willing for trial.
结局指标
主要结局
1.To evaluate the efficacy of Kuberaksha vati and Dashmoola taila matra basti in the management of udavartini yonivyapad.
时间窗: 1.after 4 weeks | 2.after 4 weeks
2.To compare the efficacy of Kuberaksha vati and Kuberaksha vati with Dashmoola Taila Matra Basti.
时间窗: 1.after 4 weeks | 2.after 4 weeks
次要结局
- 1.Conceptual Study of Udavartini Yonivyapada.(2.To find out safe & potent drug for Udavartini Yonivyapada.)