Comparative Study of Efficacy and Adverse Effects of Ginger Extract and Loratadine for Treatment of Allergic Rhinitis Patients (Clinical Trial Phase II)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Nasal symptom
研究概览
简要总结
Efficacy and adverse effects of Ginger extract in treating allergic rhinitis patients compared with Loratadine.The double blind randomized controlled trial study was approved by the Human Research Ethics Committee of Thammasat University NO.1.
详细描述
The double blind randomized controlled trial study. Patients who meet the inclusion criteria and do not fall into any exclusion criteria will be randomly placed into the experimental group, who will receive ginger extract capsules, or the control group, who will receive loratadine for 42 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have moderate allergic rhinitis (itching and nasal obstruction, watery nasal discharge, sneezing and congestion )with a minimum total nasal symptom score 7 point
- •These patients do not have the respiratory disease such as tuberculosis, nasal polyps.
- •These patients do not have the history of disease: heart disease, kidney disease, liver disease, epilepsy, high blood pressure and severe asthma.
- •These patients are not pregnant or breastfeeding.
- •These patients have normal BMI and vital signs.
排除标准
- •Those who have taken anti-coagulant and anti-platelet aggregation medications.
- •Those who get serious side effects from Loratadine and ginger allergy.
- •Communication problems especially listening and interview.
研究组 & 干预措施
Ginger extract
Drug
干预措施: Ginger extract (Drug)
Loratadine
Drug
干预措施: Loratadine (Drug)
结局指标
主要结局
Nasal symptom
时间窗: 42days
Nasal symptom from Total nasal symptom score
次要结局
- Quality of Life(42days)
- Nasal patency(42days)
研究者
Rodsarin Yamprasert
Faculty of Medicine Thammasat University
Thai Traditional Medical Knowledge Fund