THE EFFECTIVENESS OF INDIVIDUALISED HOMOEOPATHICMEDICINE ON SYMPTOMATIC IMPROVEMENT AND QUALITY OF LIFEIN WOMEN WITH URINARY INCONTINENCE
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To find out the effectiveness of homoeopathic medicines in urinary
研究概览
简要总结
Aim of the study :
To determine the effectiveness of individualised homoeopathic medicines in patients with Urinary Incontinence
Objectives of the study :
Primary Objective :
To find out the effectiveness of homoeopathic medicines in urinary incontinence disorder among women by using King’s Health Questionnaire
Hypothesis :
a..Null hypothesis :(H0)
There is no significant improvement in Urinary Incontinence patients after homoeopathic treatment.
b.Alternative hypothesis :(H1)
There is significant improvement in Urinary Incontinence patients after homoeopathic treatment.
Methods of Data Collection
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A clinical Observational study will be conducted in the outpatient department of NHRIMH,Kottayam. Referral cases selected from peripheral camps also will be included.
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After filling screening form and after performing necessary Laboratory investigations including routine blood examination , urine analysis and Ultrasound Abdomen/Pelvis will be done , and then the cases, fitting in the inclusion criteria will be enrolled into the study.
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Patient will be explained about the study in detail and written informed consent will be obtained.
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Using standard case record format, cases will be recorded followed by formation of individual totality and repertorization will be done using appropriate repertory as per the need of the case. Final selection will be done after reference with Materia medica.
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Each case will be follow up for one year after enrollment.
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Depending on the susceptibility of the patient and severity of disease,medicine will be administered in various potencies and in appropriate doses according to the homoeopathic principles.
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The Study will be conducted only after clearance from Institutional Review board , Ethical Committee , University and CTRI registration
Drop out Criteria
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If patient is not reporting for 3 or more consecutive visits, even after telephonic follow ups, that patient will be dropped out from the study.
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In case of any medical emergency, or complications, patient will be withdrawn from the study and treated as per the need or referred to higher centres for further management.
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If there is any adverse reaction noted after administration of Homoeopathic medicine it will be reported to the Institutional pharmaco-vigilance department.
Outcome measurement :
Outcome of the treatment will be measured by assessing the symptomatic improvement and quality of life in the patients using King’s Health Questionnaires after the administration of homoeopathic medicine
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 80.00 Year(s)(—)
- 性别
- Female
入选标准
- •Females with Stress/Urge/Mixed Urinary Incontinence Symptoms 2.Females of age group 18 to 80 years 3.Symtpoms assessment by validated Questionnaires 4.All cases with Comorbidities like obesity ,diabetes and other metabolic conditions ,previous pelvic surgeries.
排除标准
- •1.Cases with Acute Symptomatic Urinary tract infection excluded by Urine Analysis
- •Urinary tract congenital anomalies excluded by USG abdomen and Pelvis 3.Overflow Incontinence ,malignant pelvic neoplasms ,neuropsychiatric disorders 4.Pregnant and Lactating mothers.
结局指标
主要结局
To find out the effectiveness of homoeopathic medicines in urinary
时间窗: 6 Months enrollment with 1 year Follow up
incontinence disorder among women by using King’s Health Questionnaire
时间窗: 6 Months enrollment with 1 year Follow up
次要结局
未报告次要终点
