Clinical evaluation of Bimbimoola Syrup in Shayyamutra (Enuresis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Bedwetting frequency
研究概览
简要总结
This study is a Single blinded Randomised clinical trial to determine the efficacy of Bimbimoola syrup in Shayyamutra
(Enuresis) for the age group of 6 to 12 years for 30 days. Study will be conducted at UAU, Gurukul campus,
Haridwar on 34 patients. Assessment will be done on the basis of subjective parameters. Study will be
conducted at OPD/IPD level of PG department of Kaumarbhritya. The assignment will be done at interval of 30 days of
clinical trial and result obtained will be tabulated and statistically analyzed using appropriate tests
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
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children presenting with clinical feature of shayyamutra that is Repeated voiding of urine in bed or clothes twice a week for at least 3 consecutive months after 5 years of age.
- •Primary nocturnal enuresis.
排除标准
- •1.Children below 6 years and above 12 years.
- •2.Known case of Immune deficiency disorders, DM, DI and TB, Urinary tract infection, any other infection will be excluded, from the study.
- •3.Patients with any congenital anomalies or with anatomical deficits of genito-urinary system will not include in the study.
- •4.Secondary enuresis and diurnal eneuresis.
结局指标
主要结局
Bedwetting frequency
时间窗: The assessment of patient will be done at 1st day, 15th day, and 30th day
Lack of memory
时间窗: The assessment of patient will be done at 1st day, 15th day, and 30th day
Shamefulness
时间窗: The assessment of patient will be done at 1st day, 15th day, and 30th day
Irritability
时间窗: The assessment of patient will be done at 1st day, 15th day, and 30th day
Lack of Concentration
时间窗: The assessment of patient will be done at 1st day, 15th day, and 30th day
Fear
时间窗: The assessment of patient will be done at 1st day, 15th day, and 30th day
次要结局
- Reduction in number of enuretic episodes per week ( Bedwetting frequency )(The assessment of patient will be done at 1st day , 15th day, & 30th day)
研究者
Nancy Singh
Gurukul Campus Uttarakhand Ayurved University, Haridwar