跳至主要内容
临床试验/CTRI/2025/02/080658
CTRI/2025/02/080658招募中2 期

Role of individualised homoeopathic medicine in urinary tract infections - an in-vitro and pre-post, single arm clinical trial

National Institute of Homoeopathy1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月26日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
40
试验地点
1
主要终点
Determination of the invitro effectiveness of the individualised homoeopathic medicines against inhibiting growth of the bacterial pathogens causing chronic urinary tract infections

研究概览

简要总结

Research question - is there any inhibition in the growth of pathogens cultured invitro from urine sample collected from a particular patient after the application of individualised homoeopathic medicines chosen for that particular patient

Are individualised homoeopathic medicines effective in reducing the symptoms in patients of chronic urinary tract infections

Null hypothesis is there is no significant change in growth of pathogens cultured invitro from urine sample collected from a particular patient after the application of individualised homoeopathic medicines chosen for that particular patient

There is significant change in UTI SIQ 8 scoring in patients with chronic urinary tract infections when treated with individualised homoeopathic medicines

Alternate hypothesis is there is significant change in growth of pathogens cultured invitro from urine sample collected from a particular patient after the application of individualised homoeopathic medicines chosen for that particular patient

There is significant change in UTI SIQ 8 scoring in patients with chronic urinary tract infections when treated with individualised homoeopathic medicines

Aim is to evaluate the effectiveness of individualised homoeopathic medicines against cultured strains of bacterial pathogens causing chronic urinary tract infections

To assess the clinical effectiveness of individualised homoeopathic medicines in treating chronic urinary tract infections by determining the changes in symptom scoring of chronic urinary tract infections

Primary objectives are to determine whether there is any inhibition in the growth of pathogens cultured invitro from urine sample collected from a particular patient after the application of individualised homoeopathic medicines chosen for that particular patient

To determine the changes of UTI SIQ 8 score before and after treatment with individualised homoeopathic medicines for patients affected by chronic urinary tract infections

To determine the correlation between changes in the symptoms of chronic urinary tract infections and changes in the growth of pathogens invitro after application of individualised homoeopathic medicine chosen for that particular patient It is a single arm interventional study conducted at the OPD setting of National Institute of Homoeopathy, Kolkata where each case will be taken in detail appropriate consent taken and then the patient will be enrolled. Appropriate statistical tools will be used and data analyzed at the end of the study.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
10.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients having two or three UTIs in six months or three or more in a year or if symptoms that don’t disappear within 24 to 48 hours after treatment begins or if urinary tract infection that lasts longer than two weeks Patients of both genders different socio economic status of all religions Patients of age groups 10 to 60 years of age Patient’s parents who are willing to give written informed consent and to participate in the study and give verbal children aged between 10 to 11 years and or written assent children aged between 12 to 17 years Patients or parents or guardians of patients who can read or write or understand either English Hindi or Bengali languages.

排除标准

  • Pregnant or lactating women Patient taking any antibiotics Patients undergoing any other homeopathic medications Patient having any psychiatric or life threatening illness severe systemic illness or immuno compromised state Patients with any conditions requiring surgical interventions such as SOL malignancy or stone in PUJ or VUJ.

结局指标

主要结局

Determination of the invitro effectiveness of the individualised homoeopathic medicines against inhibiting growth of the bacterial pathogens causing chronic urinary tract infections

时间窗: Baseline 3 and 6 months

Significant changes of UTI SIQ 8 score before and after treatment with individualised homoeopathic medicines for patients affected by chronic urinary tract infection

时间窗: Baseline 3 and 6 months

次要结局

  • Determination of any correlation between clinical study and invitro bacterial inhibition(Baseline 3 and 6 months)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ezhilmathi K S

National Institute of Homoeopathy

研究点 (1)

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