Effectiveness of individualized homoeopathic medicines in treatment of urolithiasis patients on health-related quality of life : A single group, pre-post interventional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement of each case will be assessed by using USS score index. This scale will help to assess or compare the outcome of the treatment with gradation in particular level. On the basis of the score obtained from this chart, the intensity of the cases will be grouped into mild(1-7), moderate (8-14) and severe (15-22)
研究概览
简要总结
Urolithiasisis the third most common disease of urinary tract. Thisdisease affects about 12% of the whole mankind at some stage intheir lifetime. Therecurrence rate of renal stone between men and female in Asia is 2:1. This condition has been gradually lower downthe kidney function and associate with an increase rick of chronic kidneydisease and even end stage renal disease and majorityof cases are treated by surgical intervention. So,it consider as a major social and economic problem. Beside this the recurrencerate is also high, and prevention of this recurrence remains to be a serioushealth issue as it requires better understanding of mechanism involve in stoneformation.
RESEARCHQUESTION : Doesindividualhomeopathic medicine produces significant effects in health relatedquality oflife in cases of urolithiasis?
HYPOTHESIS:
NULLHYPOTHESIS (H0):
Individualizedhomoeopathicmedicine has no role in management of pain and removing of stones in cases ofuncomplicated renal stone.
Individualizedhomoeopathicmedicines has no role in improvement of health related quality of life among such patients
ALTERNATIVEHYPOTHESIS (HA):
Individualizedhomoeopathicmedicine has role in management of the pain and removing of the stones in casesof uncomplicated renal stone.
Individualizedhomoeopathicmedicine has role in improvement of health related quality of life among such patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who are diagnosed with renal stone by USG and/or Xray.
- •All sex, of all religions and of all different socio economic status 3.Patients willing to give written consent for participation.
排除标准
- •Patients with gross pathological changes like CA, chronic kidney disease, kidney failure, hydronephosis.
- •Suffering from systemic diseases like Cardiovascular disease, Hepatobiliary disease, Endocrinal disease
- •Insane, non-co-operative patient
- •Stag horn calculi, calculi in pole of kidney
- •Acute retention of urine for more than 24 hours
- •Any developmental or congenital anomaly of kidney
- •Pregnant and lactating mother.
结局指标
主要结局
Improvement of each case will be assessed by using USS score index. This scale will help to assess or compare the outcome of the treatment with gradation in particular level. On the basis of the score obtained from this chart, the intensity of the cases will be grouped into mild(1-7), moderate (8-14) and severe (15-22)
时间窗: Follow up will be done on baseline and each follow up at an interval of 4 weeks and sonography at base line and after 3 months
Reduction of stone size and also removal of stone will be confirmed by USG reports and x-ray reports.
时间窗: Follow up will be done on baseline and each follow up at an interval of 4 weeks and sonography at base line and after 3 months
次要结局
- Improvement of the general health related quality of life will be assessed by WISQOL scale(Followed will be done on baseline and each followup at an interval of 4 weeks)