A double-blind, randomized, placebo-controlled trial to evaluate the efficacy of individualized homoeopathic medicines in the treatment of chronic rhinosinusitis in adults
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Sino Nasal Outcome Test-22 questionnaire (SNOT 22)
研究概览
简要总结
Chronic rhinosinusitis is a group of disorders that is characterized by inflammation of the mucosa of the nose and paranasal sinuses and present with of at least two of the following primary clinical symptoms: anosmia, hyposmia, facial discomfort or pressure, facial congestion or fullness, purulent nasal discharge, and nasal congestion or blockage. These symptoms must persist for a minimum period of 12 weeks. Homoeopathy is a frequently used therapy to treat chronic rhinosinusitis; however, the research evidence is limited. This 3 months, double-blind, randomized, placebo-controlled trial is aimed at evaluating the efficacy of homoeopathic medicines in the treatment of chronic rhinosinusitis in 105 adults .The primary outcome is SNOT-22; the secondary outcomes are MYMOP-2 questionnaires and measure the frequency of conventional treatment utilization, all measured at baseline, and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Result will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from CRS for 12 weeks or more, who had not taken any treatment for the last 2 weeks, fulfilled the diagnostic criteria of AAO-HNS.
- •Age 18 to 65 years.
- •Patients ability to understand English, Hindi and/or Bengali.
- •Participants of either sex or transgender.
排除标准
- •Not willing to provide with written consent of voluntary participation.
- •Mild case 8 to 20 and severe case more than 50 of chronic rhinosinusitis according to SNOT 22 score.
- •3, Have DNS, swollen nasal turbinate, nasal polyp or nasal obstruction or any other structural abnormalities of nose and eyes.
- •Respiratory infections.
- •Patients with risk of developing bronchial asthma.
- •Suffering from uncontrolled systemic illness or life threatening infections.
- •Regular or excessive use of alcohol, tobacco, substance abuse and any other addiction.
- •Person under corticosteroid therapy.
- •Vulnerable population unconscious, non ambulatory, too sick for consultation, terminally ill or critically ill, mentally incompetent people.
- •Self reported immune compromised state.
- •Already undergoing homoeopathic treatment within last 3 months for any other disease.
- •Simultaneous participation in any other trial.
结局指标
主要结局
Sino Nasal Outcome Test-22 questionnaire (SNOT 22)
时间窗: Baseline, and every month, up to 3 months
次要结局
- Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) questionnaire(Baseline, and every month, up to 3 months)
- Detect the frequency of conventional treatment utilization.(Baseline, and every month, up to 3 months)
研究者
Monalisa Khatun
D N De Homoeopathic Medical College and Hospital