跳至主要内容
临床试验/CTRI/2024/03/063640
CTRI/2024/03/063640招募中2 期

Individualised Homoeopathic Treatment of Chronic Brucellosis in human beings along with Standard Care – An open-label, pragmatic, and two arm Pilot Study

Central Council for Research in Homoeopathy1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
54
试验地点
1
主要终点
symptomatic profile of the pateint will be assessed by cured,major improvemnt,moderate improvement,slight improvement,no changes,slight detioration,moderate detioration ,major detioration and diststrous detioration.MYMOP 2 tool to find the improvemnt.

研究概览

简要总结

Brucellosis, classified among the "seven neglected endemic zoonoses" by the World Health Organization (WHO), continues to pose significant health concerns, particularly in regions like Western Asia, the Middle East, the Mediterranean, and Central and South America. Despite progress in control efforts, its persistence in areas like Peru, Kuwait, and Saudi Arabia underscores the need for ongoing monitoring and interventions. Brucellosis, caused by Brucella sp., not only affects animals but also poses financial burdens on affected individuals due to hospital care, pharmacotherapy, and lost income from sick leave.

The clinical manifestations of Brucellosis encompass fever, sweats, fatigue, anorexia, headache, arthralgia, and back pain. Recognizing these symptoms, exceedingly prolonged fever without an evident cause is crucial for early diagnosis.

While the mortality rate is low, timely diagnosis and therapy are critical, particularly in cases of endocarditis or central nervous system involvement. Focal disease cases may require intensive therapeutic approaches, including surgical intervention and extended antibiotic therapy.

Research into combining homoeopathic treatments with allopathic standard care for Brucellosis may yield valuable evidence. Well-designed clinical studies can establish a robust body of evidence, enhancing our understanding and management of the disease. This integrated approach evaluates the ADD-ON effects of homoeopathic remedies alongside established allopathic protocols, which may contribute to evidence-based healthcare practices. The ultimate goal is to improve treatment strategies for Brucellosis, offering clinicians more comprehensive options and benefiting patients by potentially enhancing outcomes and quality of life. This research aligns with a commitment to delivering the best care through an evidence-backed, integrative approach.

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

入选标准

  • •Patients aged between 18 and 60 present with clinical signs and symptoms of recurrent or chronic Brucellosis.
  • (Chronic brucellosis refers to patients whose symptoms persist for 12 months or more from diagnosis and treatment ).
  • •Patients willing to give informed consent.

排除标准

  • •Known cases of uncontrolled diabetes hypertension.
  • •Person with any organic changes CA and others, i.e. tuberculosis, etc.
  • •Severe condition of the patient in any aspect of health.
  • •Pregnant or lactating women.

结局指标

主要结局

symptomatic profile of the pateint will be assessed by cured,major improvemnt,moderate improvement,slight improvement,no changes,slight detioration,moderate detioration ,major detioration and diststrous detioration.MYMOP 2 tool to find the improvemnt.

时间窗: base line, Every 03 day for first 1 month(09 times),consecutively per month for next 11 months.

次要结局

  • To assess the Quality of Life (QoL) using the EQ-5D-5L questionnaire as a parameter to compare and detect differences between two groups. This evaluation will provide valuable insights into the impact of the treatment approach on the overall well-being and quality of life of patients in each group.(To assess the Quality of Life (QoL) using the EQ-5D-5L questionnaire EVERY MONTH, UPTO 12 TH MONTH.)

研究者

发起方
Central Council for Research in Homoeopathy
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

DrChittaranjan Kundu

Central Council for Research in Homoeopathy

研究点 (1)

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