Management of Chronic rhinosinusitis in adults with individualized homoeopathic medicines in different scales- An open label randomized triple arm pragmatic trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Sino Nasal Outcome Test
研究概览
简要总结
Chronic rhinosinusitis (CRS) is one of the most common chronic and debilitating conditions affecting 10-15% of the world population. An estimated 134 million Indians suffer from CRS. It has been shown to impair quality of life (QoL) and increase the risk of depression, anxiety, mood and sleep disorders and has significant morbidity and healthcare expenditure. Current management techniques mainly target to reduce inflammation with a variable results and endoscopic sinus surgery (ESS). Though homeopathy is one of the popular choice of CRS patients but effects of classical or individualized form of homeopathy (IH) remained unexplored. In this open label randomized triple arm pragmatic trial at The Calcutta Homoeopathic Medical College and Hospital, 111 patients suffering from CRS will be randomized to receive individualized homoeopathic medicines in centesimal scale(n=37), individualized homoeopathic medicines in decimal scale (n=37), individualized homoeopathic medicines in fifty millesimalscale (n=37) . We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homeopathy (IH) in treatment of CRS and to investigate whether there are any differences in outcomes between these three groups over 3 months of intervention. Sino-nasal Outcome Test-22 (SNOT-22) and EQ-5D-5L will be used as the primary and secondary outcome measures respectively. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of both sexes2.Patients of age between 18 to 65 years 3.Patient having chronic rhinosinusitis (CRS) [ICD-11 CA0A.Y] since 12 weeks or more, fulfilling the diagnostic criteria of AAO-HNS50 4.Case presenting with complaints like running nose, headache etc of chronic rhinosinusitis by using SINONASAL OUTCOME TEST (SNOT22)5.Patients undergoing X Ray paranasal sinus which show finding of chronic rhinosinusitis 6.Patients who have not taken any treatment since last 2 weeks for CRS 7.Patients who are literate, can read bengali, hindi, english, capable of filling the questionnaire 8.Providing written informed consent voluntarily.
排除标准
- •1.Cases suffering from uncontrolled systemic illness or life-threatening infections2.Cases suffering from complications of CRS 3.Cases insisting for or in need of surgical interventions, major ENT surgery within last 6 months4.Patients with previous history of nose surgery5.Patients having DNS, cleft lip, otitis media6.Patients who are undergoing treatment with antibiotics, glucocorticoids or antihistamines during 2 weeks prior to enrolment in the study 7.Cases already undergoing homeopathic treatment for any chronic disease since last 6 months8.Substance abuse and/or dependence9.Pregnant, puerperial or lactating women10.Patients with psychiatric diseases11.Self-reported immune-compromised states 12.Vulnerable population – Unconscious, non-ambulatory, too ill for consultation, differently abled, terminally ill or critically ill patients, mentally disabled people13.Simultaneous participation in any other clinical trial.
结局指标
主要结局
Sino Nasal Outcome Test
时间窗: At baseline, and every month, up to 3 months
(SNOT22)
时间窗: At baseline, and every month, up to 3 months
次要结局
- EQ-5D-5L questionnaire(At baseline, and every month, up to 3 months)
研究者
Deepak Kumar
The Calcutta Homoeopathic Medical College and Hospital