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临床试验/CTRI/2024/02/062992
CTRI/2024/02/062992尚未招募2 期

A Randomised Placebo Control Clinical Trial To Verify The Efficacy Of Homoeopathic Medicines In Cases Of Acute Cystitis In Female.

Rajkot Homoeopathic Medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月26日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To ascertain the role of Homoeopathic Medicines in cases of Acute Cystitis in female by using Acute Cystitis Symptom Score (ACSS)

研究概览

简要总结

The term acute simple cystitis to refer to an acute urinary tract infection (UTI) that is presumed to be confined to the bladder. Such infections lack signs or symptoms that suggest an infection extending beyond the bladder, which include:

Fever (>99.9°F/37.7°C).

Other signs or symptoms of systemic illness (including chills or rigors, significant fatigue or malaise beyond baseline).

Flank pain.

Cystitis among women is extremely common. The shorter distance from the anus to the urethra likely explains why women are at higher risk for urinary tract infections (UTIs) than men. Among otherwise healthy women, risk factors for cystitis include recent sexual intercourse and a history of UTI. Use of spermicide-coated condoms, diaphragms, and spermicides alone are also associated with an increased cystitis risk. Other comorbidities, such as diabetes mellitus and structural or functional urinary tract abnormalities, can also increase the risk of cystitis.

A study consisting of 2 044 065 females who were 15-50 years of age during the study period (1997-2018) .The study identified 546 076 first events of uncomplicated cystitis (26.7% of the study population), In fully adjusted models, rural living was associated with lower risks of uncomplicated cystitis compared to urban living, while both Middle Eastern/North African and Latin American/Caribbean women had higher risks compared to Swedish women. Low education and low income were also associated with higher risks compared to high education and high income.

in this trial the investigator intend to assess the efficacy of individualised Homoeopathic  Medicine for Acute Cystitis in Female on 100 patients in a single blind, randomised, parallel arm, placebo controlled design in the outpatient of Sainath Homoeopathic Hoapital, attached with Rajkot Homoeopathic Medical College, Dist-Rajkot 360002, Gujarat, India. The patients will be prescribed either individualised Homoeopathic Medicine or identical Placebo. Data will be gathered at base line and after completing treatment using acute Cystitis Symptoms Score. Randomization will be computer generated. The collected data will be subjected to statistical analysis. The main aim is to evaluate the effectiveness of individualised Homoeopathic Medicine than placebo in cases of Acute Cystitis in Female.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Pre-diagnosed cases of Acute cystitis or new cases showing sign and symptoms of acute cystitis.
  • Female patients
  • Female of age group 18 years to 60 years.

排除标准

  • Age less than 18 years and more than 60 years.
  • Patients with acute cystitis who were on other therapeutic measures.
  • Patients with other systemic disorders and other urinary tract diseases.
  • Substance induced acute cystitis.

结局指标

主要结局

To ascertain the role of Homoeopathic Medicines in cases of Acute Cystitis in female by using Acute Cystitis Symptom Score (ACSS)

时间窗: 6 months

次要结局

  • To prepare therapeutic compendium of Homoeopathic Medicines in cases of Acute Cystitis in Female.(6 months)

研究者

发起方
Rajkot Homoeopathic Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Janakiben Rajnikant Bhanvadia

Rajkot Homoeopathic Medical College

研究点 (1)

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