Efficacy of constitutional homoeopathic medicines in patients with non-surgical chronic rhinosinusitis: a prospective, randomized, double-blind, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Sino-nasal Outcome Test 20 (SNOT-20) questionnaire (translated Bengali version)
研究概览
简要总结
Chronic sinusitis is one of the mostprevalent chronic illnesses all over the world. An estimated134 million Indians suffer from chronic rhinosinusitis (CRS), 1 in 8 Indianssuffer from CRS. According to the,National Ambulatory Medical Care Survey, sinusitis is the fifth most commondiagnosis treated with antibiotics. Thus CRS has significant economicimplications. The small benefit gained for short duration may be masked by thenegative effects of antibiotics and the high recurrence rate of CRS. Homeopathymay hold promise in successful treatment of CRS, but has remainedunder-researched. In this double-blind, randomized, placebo-controlled,clinical trial at National Institute of Homoeopathy, 62 patients will berandomized to either individualized homoeopathic treatment + saline inhalation(n=31) or indistinguishable placebo + saline inhalation (n=31) to examinewhether individualized homoeopathy have any different effect from placebo intreatment of CRS. Sino-nasal Outcome Test 20 (SNOT-20) questionnaire (SNOT-20)scores, EQ-5D-5L scores, and 5 numeric rating scales measuring severity ofsneezing, rhinorrhoea, post-nasal drip (PND), facial pain or pressure, and lossof sense of smell will be assessed at baseline, after 2 months, and after 4months. Comparative analysis will be carried out to examine group differences,if any. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Investigator Blinded
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 of both sexes
- •Patients of age between 18 and 60 years
- •Patients having chronic rhino-sinusitis (CRS) since 12 weeks or more, fulfilling the diagnostic criteria of AAO-HNS.
- •Patients who have not taken any treatment since last 2 weeks for CRS.
- •Patients willing to take only homoeopathic medicines.
排除标准
- •Patients suffering from other uncontrolled systemic diseases (like DM, Cancer and Thyroid diseases etc.), uncontrolled infections or any vital organ failure.
- •Patients suffering from the complications of CRS.
- •Patients who are insisting for or in need of surgical interventions.
- •Patients who are undergoing treatment with antibiotics, glucocorticosteroids or antihistamines during 2 weeks prior to enrolment in the study.
- •Psychiatrically unstable patients
- •Self-reported immune-compromised patients
- •Substance abuse and/or dependence
- •Pregnant women and lactating mothers
- •Already undergoing homoeopathic treatment for any chronic disease since last 6 months.
结局指标
主要结局
Sino-nasal Outcome Test 20 (SNOT-20) questionnaire (translated Bengali version)
时间窗: Baseline, 2 months, 4 months
次要结局
- EQ-5D-5L questionnaire (Bengali version)(Baseline, 2 months, 4 months)
- Five numeric rating scales (0-10) measuring severity of sneezing, rhinorrhoea, post-nasal drip (PND), facial pain or pressure, and loss of sense of smell(Baseline, 2 months, 4 months)