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临床试验/CTRI/2025/03/082228
CTRI/2025/03/082228尚未招募2/3 期

Effect of Individualized Homoeopathic Medicines in the Management of Chronic Bronchitis : A prospective, single arm, prepost, clinical trial

The Calcutta Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年3月18日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
To assess the improvement in the FEV1/FVC through Spirometry in chronic bronchitis patients treated with Individualized Homoeopathic Medicine

研究概览

简要总结

Chronic bronchitis (ICD-11 Code J41.0) is a chronic miasmatic disease which has been classically defined as chronic cough with sputum expectoration for at least 3 months per year for two consecutive years provided there are no other underlying cause that can explain these symptoms (an important caveat that is often ignored). The hallmark symptom of CB is chronic cough which is often associated with sputum production. According to the classic definition, this cough occurs for at least two years in a row, lasts for three months each year, and is present on the majority of days in a month. In the appropriate clinical context CB can be diagnosed by the presence of non-reversible airflow obstruction (FEV1/FVC < 0.7 post bronchodilation).  Following preliminary screening for Chronic Bronchitis symptoms and detailed screening using specified selection criteria, eligible patients will be recruited in the trial. Following that, outcome data will be obtained. Each case will be studied properly through analysis and evaluation of each and every symptom then accordingly qualitative picture will be constructed on the basis of totality of symptom to prescribe simillimum. Every patient will be assessed periodically to follow-up the reaction of the remedy through SGRQ at the baseline and after 3 months. Spirometry will be done at the baseline and at the end of 3 months. The usual follow up will be done at an interval of 4 weeks and will be recorded in follow-up sheets.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Clinical history of chronic cough with sputum expectoration for at least 3 months per year for two consecutive years
  • FEV1/FVC less than 0.7 and FEV1 greater than 80% predicted
  • Age between 18 and 65 years and of either gender
  • Individuals who can read and or write English or Bengali
  • Individuals willing to participate in trial and give written consent for the same.

排除标准

  • Individuals who are currently on any other homoeopathic treatment or undergoing any kind of treatment for chronic bronchitis from any system of medicine
  • Individuals with life threatening diseases
  • Lung cancer known or suspected
  • Individuals requiring Oxygen therapy or hospitalisation
  • Pregnant or lactating mothers
  • Individuals having any substance abuse or severe psychiatric illness
  • Individuals who have not taken any other homoeopathic medicine for at least 6 weeks
  • Self-reported immunocompromised states.

结局指标

主要结局

To assess the improvement in the FEV1/FVC through Spirometry in chronic bronchitis patients treated with Individualized Homoeopathic Medicine

时间窗: At the baseline and after 3 months

次要结局

  • To assess the standard of treatment in chronic bronchitis patients with individualized homoeopathic medicine by using St. George’s Respiratory Questionnaire(At the baseline and after 3 months)

研究者

发起方
The Calcutta Homoeopathic Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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