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临床试验/CTRI/2025/09/094480
CTRI/2025/09/094480尚未招募不适用

A CLINICAL STUDY ON THE EFFECTIVENESS OF HOMOEOPATHIC MEDICINE SEPIA OFFICINALIS IN THE TREATMENT OF RECURRENT CYSTITIS IN POSTMENOPAUSAL WOMEN

Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
The effectiveness of the Homoeopathic medicine Sepia officinalis will be evaluated based on the percentage reduction in the Acute Cystitis Symptom Score from pre-treatment to post treatment.

研究概览

简要总结

·       Recurrent cystitis is a prevalent urological condition, particularly in postmenopausal women, affecting their quality of life, daily activities, and mental well-being. Recurrent lower urinary tract infections are common after the menopause and occur in more than 10 percentage of women over the age of 60. Due to estrogen deficiency there is rise in vaginal pH promotes an alteration in the normal vaginal flora, with decreased lactobacilli leading to increased colonization by pathogenic faecal flora. This increases the incidence of urinary tract infections in postmenopausal women. Recurrent UTI refers to a group of patients who have suffered from a UTI at least three times in the last 12 months or at least two times during the previous 6 months and have diminished quality of life. The purpose of this study is to do a systematic clinical evaluation of Sepia officinalis in the treatment of recurrent cystitis in postmenopausal women. The validated Acute Cystitis Symptom Score will be used as an evaluation assessment tool to measure the degree of improvement and symptom severity after homoeopathic treatment. The objective of my study is to assess whether individualized Sepia officinalis therapy can effectively reduce the frequency and severity of recurrent cystitis episodes, and to evaluate improvement using a validated symptom-based scale. A minimum of 30 postmenopausal women with recurrent cystitis will be selected from OPD, IPD, and peripheral centers of White Memorial Homoeopathic Medical College and Hospital. Detailed case records as per the approved format will be maintained, and diagnosis will be confirmed using clinical history and the Acute Cystitis Symptom Score supported by clinical examination and urine tests when needed. Sepia officinalis will be prescribed and patients will be followed weekly during acute episodes, then every two weeks or as required for six months. Improvement will be assessed by comparing pre and post treatment ACSS scores. The effectiveness of the Homoeopathic medicine Sepia officinalis will be evaluated based on the percentage reduction in the Acute Cystitis Symptom Score from pre-treatment to post treatment.

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
45.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • Postmenopausal status (12 or more than 12 months of amenorrhea) Patients with more than 1 episodes of acute uncomplicated cystitis in the last 6 months.
  • ACSS score of 6 or more used as the cutoff for diagnosis and confirmed by urine analysis and urine culture.

排除标准

  • Complicated UTIs, including Pyelonephritis, UTI with kidney stones, structural abnormalities, or catheters.
  • History of diabetes mellitus or immunosuppressive conditions affecting UTI susceptibility.
  • Severe renal impairment or chronic kidney disease.

结局指标

主要结局

The effectiveness of the Homoeopathic medicine Sepia officinalis will be evaluated based on the percentage reduction in the Acute Cystitis Symptom Score from pre-treatment to post treatment.

时间窗: 6 months

Outcome will be classified as follows:

时间窗: 6 months

Mild improvement: 1 – 33%

时间窗: 6 months

Moderate improvement: 34 – 66%

时间窗: 6 months

Marked improvement: 67 – 99%

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr ISWARYA H

White Memorial Homoeo Medical College and Hospital

研究点 (1)

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