A single blind clinical study to assess the efficacy of Viola Odorata in management of Chronic Bronchitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To check the effectiveness of Viola Odorata in cases of Chronic Bronchiti using chronic bronchitis severity scale at day 1 and at every follow up.
研究概览
简要总结
This study is the Non-Randomized, Single Blind Clinical trial to assess the effect of homoeopathic medicine Viola Odorata in the management of chronic Bronchitis in patients . The duration of treatment will be 3 months and will be done on 30 patients at Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Pune. The severity of the disease will be measured by Chronic Bronchitis severity scale on Day 1. The primary outcome will measure the effectiveness of Viola Odorata, that will be assessed from the follow-ups taken for 3 months. The secondary outcome will be measured by studying the reduction in the symptoms of chronic Bronchitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Those cases fulfilling the CBSS criteria and suffering is since 2 years or more.
- •Patients of All sexes will be included in the study.
- •Patients of 18 to 40 years age groups of various socio-economic groups will be included.
- •Patient without any other systemic diseases.
- •Patient giving written consent form.
- •Patients coming under the case definition according to CBSS will be included.
排除标准
- •That doesn’t fulfill CBSS criteria.
- •Cases with serious complication of Respiratory system and/or recently taking strong steroidal medication and having acute exacerbation of bronchitis.
- •Patients with Psychiatric diagnosis.
- •Pregnant and lactating women.
- •Malignancy cases.
- •Recent major surgery.
- •Immuno compromised cases.
- •Patients who have participated in any other Research study in last 6 months 9.Those under other medications for other diseases.
结局指标
主要结局
To check the effectiveness of Viola Odorata in cases of Chronic Bronchiti using chronic bronchitis severity scale at day 1 and at every follow up.
时间窗: Improvement according to chronic bronchitis severity scale at day 1 and again after | every 15 days, for the total of 12 weeks will be assessed in every case to see the effect of viola odorata.
次要结局
- To give the maximum relief of symptoms of the patient by following up at every 7 days and to minimize the frequency of symptom of cough and wheezing in patient using CAT assessment.(CAT assessment used at day 1 and at every 7 days so assess the frequency of symptoms of cough and wheezing patients within 12 weeks of duration.)