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临床试验/CTRI/2024/08/072622
CTRI/2024/08/072622Not Applicable2 期

Effects of individualized homoeopathic medicine on quality of life of patients with chronic sinusitis using SNOT22 – An experimental control study

Dr Vijayraje alias Satish Santram Karnik1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年8月30日最近更新:

试验速览

阶段
2 期
状态
Not Applicable
发起方
入组人数
130
试验地点
1
主要终点
1) To study the change in clinical features of Chronic Sinusitis before and after treatment using SNOT-22.

研究概览

简要总结

Chronic rhinosinusitis (CRS) is a common disorder, with up to an estimated 134 million Indian sufferers, and having significant impact on quality of life (QOL) and health costs.

Chronic sinusitis is characterized by symptoms of sinus inflammation lasting >12 weeks. This illness is most commonly associated with either bacteria or fungi infections [1].Typically causes nasal congestion, blockage or discharge, and may be accompanied by facial pain or loss of smell. Examination reveals erythematous swollen nasal mucosa with pus [2].

The Task Force of the Rhinology and Paranasal Sinus Committee in 1997 suggested the term rhinosinusitis (RS), instead of sinusitis. [3]

In one year, there were up to 73 million restricted activity days in patients with sinusitis. In addition, up to 14.7% of people in one National Health Interview Survey had sinusitis the preceding year. There are higher rates of sinusitis in the South, Midwest, and among women. Children younger than 15 years of age and adults aged 25 to 64 years are affected the most. Genetic factors influence the susceptibility to sinusitis. [4]

Quality of life is patient’s ability to enjoy normal life activities. It is an important consideration in medical care. Some medical treatments can seriously impair quality of life without providing appreciable benefit, whereas others greatly enhance quality of life.

The drastic negative effect of sinusitis on patients’ quality of life has been generally underappreciated and unrecognized. Recent studies show that patients score the effects of chronic sinus disease in areas such as bodily pain and social functioning as more debilitating than diseases such as angina, congestive heart failure, emphysema, chronic bronchitis, and lower back pain, to name a few. In the past, many patients were told they would just have to "live with" their sinus problem

The most widely used patient-reported outcome measures (PROM) for CRS patients is the Sino-Nasal Outcome Test (SNOT) instrument. The SNOT instrument is a collection of several validated instruments (SNOT-16, SNOT-20, SNOT-22) defined by the number of included items. All of the SNOT instruments are derived from the Rhino-Sinusitis Outcome Measure (RSOM-31)

There are many researches available who have tested validity and reliability of the SNOT 22 and have concluded it to be showing good reliability and validity for CRS.[5]

In the study “Assessment of health -related quality of life in patients with chronic Rhinosinusitis – validation of the German Sino -Nasal Outcome Test 22”concluded that it is reliable, valid and responsive questionnaire to assess symptoms, HRQOL and treatment response in CRS patients. Good psychometric properties were observed.6]A wide range of medical/surgical therapies has been used to treat chronic sinusitis. Modern Medical therapy includes antibiotics, corticosteroids, decongestants, antihistamines, mast�’cell stabilizers, anti�’leukotriene, nasal douching, immunotherapy and reduction of environmental factors [7]. Nasal Saline Irrigation is found to be beneficial while surgery is reserved for mostly complicated cases. Overuse and unnecessary selection of antibiotic drugs leads to increased drug resistance for respiratory pathogens which paves way to chronic disease and increased treatment costs [8]. Homoeopathic medicines are reported to cause improvement in a range of chronic recurring pathologies and especially respiratory disorders [9], [10]. Homoeopathy differs with regular medicine in its interpretation and application of several fundamental principles of science. It is these differences of interpretation and the practice growing out of them which give homoeopathy its individuality and continue its existence as a distinct school of medicine [11]. Considering chronic sinusitis not only physical suffering but a condition affecting whole quality of life of patient, “Effects of individualized homoeopathic medicine on quality of life of patients with chronic sinusitis using snot22 –” will be studied.

研究设计

研究类型
Interventional
分配方式
Other
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

  • 1.Patients above 18 years of age 2.Patients from various socio-economic status & all the sexes will be considered for study.

排除标准

  • Patients suffering from complications of chronic sinusitis
  • Pregnant and lactating females
  • Patients who are suspected Immuno compromised
  • Patient suffering from Malignancy.

结局指标

主要结局

1) To study the change in clinical features of Chronic Sinusitis before and after treatment using SNOT-22.

时间窗: Duration of study – 18 months | Duration of each case – Each case will be studied for up to 7 days or till remission occurs whichever is earlier. | Duration of followup each case – each case will be followed up every month or whenever required | whole results of outcome will be explained at the end of 18 months.

2) To study the therapeutics of Chronic Sinusitis.

时间窗: Duration of study – 18 months | Duration of each case – Each case will be studied for up to 7 days or till remission occurs whichever is earlier. | Duration of followup each case – each case will be followed up every month or whenever required | whole results of outcome will be explained at the end of 18 months.

次要结局

  • 1.As per the work done on psychometric & clinometric validity of 22-Item (SINO NASAL OUTCOME TEST) or SNOT-22; SNOT-22 will be taken as a reliable scoring chart.(The SNOT-20 does have an importance rating. Patients will be asked to indicate the 5 items that are most important to them & that they expect to improve with treatment.)

研究者

发起方
Dr Vijayraje alias Satish Santram Karnik
申办方类型
Other [self sponsored research]
责任方
Principal Investigator
主要研究者

Dr Vijayraje alias Satish Santram Karnik

SJPES HMC and hospital Kolhapur

研究点 (1)

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