Effectiveness of Individualised Homoeopathic medicinesin comparison with Berberis Vulgarisin the treatment of Urolithiasis:An open label prospective randomised clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Primary outcome: Urolithiasis Symptom Score (USS score)
研究概览
简要总结
Urolithiasis is the formation of urinary calculi in the urinary system. Urolithiasis is a common, highly recurrent disease with increasing prevalence worldwide. Apart from conservative treatment, extra corporeal shock-wave lithotripsy (ESWL)and ureteroscopy are commonly practiced in conventional medicine in cases of calculi, but these interventions are expensive for the common people and may lead to complications. The possible morbidity, significant cost and the need for highly specialized equipment and special expertise raise the question whether the current treatments are indeed the most attractive options to meet the increasing demand. Hence it would be worthwhile to look for an alternative, by using homoeopathic medicines for the treatment of urolithiasis.
HYPOTHESES:
A. i) NULL HYPOTHESIS(H0): There is no significant difference in the Urolithiasis Symptoms Score(USS) before and after treatment of urolithiasis with Individualised Homoeopathic (IH) medicines. ➢ ii)ALTERNATIVE HYPOTHESIS (HA): There is a significant difference in the Urolithiasis Symptoms Score(USS) before and after treatment of urolithiasis with Individualised Homoeopathic(IH) medicines.
B. i) NULL HYPOTHESIS(H0): There is no significant difference in the Urolithiasis Symptoms Score(USS) before and after treatment of urolithiasis with Berberis Vulgaris(BV).
ii) ALTERNATIVE HYPOTHESIS (HA): There is a significant difference in the Urolithiasis Symptoms Score(USS) before and after treatment of urolithiasis with Berberis Vulgaris(BV).
C. i) NULL HYPOTHESIS(H0): There is no significant difference in changes (before and after treatment) of Urolithiasis Symptoms Score(USS) in Individualised Homoeopathic (IH)medicines in comparison with Berberis Vulgaris (BV) in the treatment of urolithiasis.
ii) ALTERNATIVE HYPOTHESIS (HA): There is a significant difference in changes (before and after treatment) of Urolithiasis Symptoms Score(USS) in Individualised Homoeopathic (IH) medicines in comparison with Berberis Vulgaris (BV) in the treatment of urolithiasis.
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
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with urolithiasis (by radiological evidence: Ultrasonography of lower abdomen/K.U.B/C.T/M.R.I etc.) 2.Patients between 20-70 years of age, all religions, all socio-economic status.
- •3.All sexes, genders, races.
- •4.Patients who are on lifesaving conventional drug therapies (e,g antidiabetics, antihypertensives, thyroid drugs)to be continued uninterrupted.
- •6.Patients who are willing to give written consent to participate in the study.
排除标准
- •Diagnosed cases of unstable mental or psychiatric illness.
- •2.Patients who are suffering from any life-threatening illness or other uncontrolled systemic disease affecting quality of life or any other vital organ.
- •3.Patients who are suffering from any major complication, Congenital Anomalies of Kidney and the Urinary Tract, severe hydronephrosis.
- •4.Patients who are on active treatment from any other system of medicine.
- •5.Patients not willing to give consent for participation in the study.
- •6.Patients not willing to undergo any investigation if advised.
结局指标
主要结局
Primary outcome: Urolithiasis Symptom Score (USS score)
时间窗: Baseline,3rd and 6th month of treatment
On the basis of score obtained from USS index chart, cases according to intensity
时间窗: Baseline,3rd and 6th month of treatment
will be grouped into mild (1-7), moderate (8-14) and severe (15-22). The scores of the initial
时间窗: Baseline,3rd and 6th month of treatment
and follow ups will be compared.
时间窗: Baseline,3rd and 6th month of treatment
次要结局
- Ultrasonography of KUB region at baseline,3(rd and 6th month of treatment will be)