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临床试验/CTRI/2022/10/046919
CTRI/2022/10/046919尚未招募3 期

THE EFFECTIVENESS OF INDIVIDUALISED HOMOEOPATHICMEDICINE ON SYMPTOMATIC IMPROVEMENT AND QUALITY OF LIFEIN WOMEN WITH URINARY INCONTINENCE

DR VINITHA T1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月11日最近更新:

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

  1. A clinical Observational study will be conducted in the outpatient department of NHRIMH,Kottayam. Referral cases selected from peripheral camps also will  be included.

  2. 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.

  3. Patient will be explained about the study in detail and written informed consent will be obtained.

  4. 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.

  5. Each case will be follow up for one year after enrollment.

  6. 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.

  7. The Study will be conducted only after clearance from Institutional Review board , Ethical Committee , University and CTRI registration

Drop out Criteria

  1. 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.

  2. 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.

  3. 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

研究者

发起方
DR VINITHA T
申办方类型
Other [self]

研究点 (1)

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