A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED MULITCENTRIC TRIAL ON THE EFFECTS OF HOMOEOPATHIC MEDICINES ON CHRONIC RHINOSINUSITIS
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- •To assess the improvement in the TSS over 3 months with area under the curve.
研究概览
简要总结
A Randomized Double Blind Placebo Controlled Mulitcentric Trial on the effects of Homoeopathic Medicines on Chronic Rhinosinusitis shall be conducted by Central Council for Research in Homoeopathy at its four institutes for a duration of 18 months (6 months for enrollment + 3 months treatment+ 3 months observation period+ 6 months for data analysis and manuscript preparation) with primary objective to evaluate the changes in total symptoms score (TSS) and the changes in Sino nasal outcome test -22 (SNOT-22). A total of 120 patients shall be enrolled (30 for each centre in the ratio Homoeoapthy:Placebo:20:10). The main Inclusion Criteria are Patients suffering from chronic rhinosinusitis (with or without nasal polyps) as defined in European Position paper on rhinosinusitis and polyps 2007.i.e. Presence of two or more symptoms one of which should be nasal blockage/ obstruction/congestion or nasal discharge (anterior/posterior nasal drip), facial pain/pressure, reduction or loss of smell for >12 weeks with validation by interview, Written informed consent, Patients who can act in accordance with the protocol, evidence of rhinosinusitis on imaging by CT Scan. One group will be given individualized homoeopathic medicines and the other group will be given placebo orally. For a period of 3 months.TSS score, Sino Nasal Outcome Test-22, Lund Mackay CT scoring, Nasal Endoscopy scoring, Absolute Eosinophil Count (AEC) will be used for assessement.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •1.Age group between 18-60 years from both gender. 2.Patients suffering from chronic rhinosinusitis (with or without nasal polyps) as defined in European Position paper on rhinosinusitis and polyps 2007.i.e. -Presence of two or more symptoms one of which should be nasal blockage/ obstruction/congestion or nasal discharge (anterior/posterior nasal drip):.
- •facial pain/pressure.
- •reduction or loss of smell for >12 weeks with validation by interview. 3 Written informed consent 4 Patients who can act in accordance with the protocol.
排除标准
- •1Patients who are not adequately symptomatic.
- •2Patients with serious underlying medical condition (eg.
- •Severe renal or hepatic disease) 3Patients with history of malignancy.
- •4Patients taken any medication prior to entry into the study (can be enrolled after wash out period of 15 days).
- •5Patients taken topical steroids within 4 weeks before the study therapy (can be enrolled after wash out period of 1 month) 6 Atrophic rhinitis 7Complications of chronic rhinosinusitis 8Significant psychological problems 9Pregnant women 10 Lactating mother 11Do not give informed consent.
- •12H/o of underlying immunodeficiencies, cystic fibrosis, bronchiectasis, chronic obstructive pulmonary disease, diabetes mellitus, neoplasia or fungal sinusitis.
- •13Systemic diseases preventing participation in the study and medical and/or surgical treatments influencing the study.
- •14 No prior paranasal sinus, nose surgery.
结局指标
主要结局
•To assess the improvement in the TSS over 3 months with area under the curve.
时间窗: •To assess the improvement in the TSS over 3 months with area under the curve. | •The changes from baseline to 3 months in the Sinus Nasal Outcome Test 22 (SNOT-22)
•The changes from baseline to 3 months in the Sinus Nasal Outcome Test 22 (SNOT-22)
时间窗: •To assess the improvement in the TSS over 3 months with area under the curve. | •The changes from baseline to 3 months in the Sinus Nasal Outcome Test 22 (SNOT-22)
次要结局
- •Change in SNOT-22 at 6 months(•Objective clinical and laboratory outcome measures include changes in nasal endoscopy (at 3 months, 6 months) and CT scan (at 3 months).)