The Study of Efficacy and Adverse Effects of Prapchompoothaweep Remedy Crude Drug and Loratadine for Treatment in Allergic Rhinitis Patients (Clinical Trials Phase II)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Nasal cavity Change from baseline at 6 weeks
研究概览
简要总结
- To compare the effectiveness of Prapchompoothaweep crude drug at 3,000 mg per day and Loratadine 10 mg per day for treatment in Allergic Rhinitis patients. (Clinical Trial Phase II)
- To evaluate the safety and adverse effect of Prapchompoothaweep crude drug at 3,000 mg and Loratadine 10 mg for Allergic Rhinitis patients.
详细描述
this study is a double blind randomized controlled trial study.
the volunteers will be divided into 2 groups. One is received Prapchompoothaweep crude drug capsule at 1,000 mg 3 times a day before meals and the other is received Loratadine 10 mg per day before meals. it takes 6 weeks to complete the project for each volunteers.
Before enrolling, volunteers will stop using any anti-histamine drug for 1 week (wash-out period). All volunteers will be followed up in the 3rd and 6th week to evaluate the efficacy and adverse effect after received drugs.
The researcher will record characteristic data such as gender, age, BMI, vital signs and symptoms . The adverse effect will be monitored by hematology test e.g. liver function test, renal function test, lipid profile and blood sugar test.
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
- 是
入选标准
- •Aged between 18-70 years old.
- •Patients with history of allergic rhinitis based on ARIA guidelines. (itching and nasal obstruction, watery nasal discharge, sneezing ,congestion)
- •Patients with moderate allergic rhinitis was diagnosed by physicians.
- •Have no nasal septum perforation, nasal polyp or sinus surgery.
- •Have no serious medical conditions: Heart disease, Liver disease, Renal disease, Hypertension, Peptic Ulcer and Gastroesophageal reflux disease (GERD), severe Asthma, Tuberculosis.
- •Have normal range of Hematology test for Liver and Renal function.
- •No Pregnant or Lactation.
- •Do not taking a medicine constantly.
- •Volunteers are willing to participate this study.
排除标准
- •Allergic reactions to Prapchompoothaweep remedy and Loratadine.
- •Allergic reaction to dairy products.
- •Have severe urticaria and anaphylaxis.
- •Have a serious condition of immunodeficiency disease: HIV in the previous month before being recruited in the study.
- •Participate in another study.
研究组 & 干预措施
Prapchompoothaweep
Group 1 will be received Prapchompoothaweep remedy 1,000 mg for 3 times before meals (for 6 weeks).
干预措施: Prapchompoothaweep remedy (Drug)
Loratadine
Group 2 will be received Loratadine 10 mg per day before meals (for 6 weeks)
干预措施: Loratadine 10 Mg (Drug)
结局指标
主要结局
Nasal cavity Change from baseline at 6 weeks
时间窗: week-0, week-3 and week-6
Using an Acoustic Rhinometry to evaluate nasal symptoms
次要结局
- Liver Function Change from baseline at 6 weeks.(week-0, week-3 and week-6)
- Renal Function Change from baseline at 6 weeks.(week-0, week-3 and week-6)
- Assessment of well-being of volunteer that change from baseline at 6 weeks.(week-0, week-3 and week-6)
- Nasal symptoms Change from baseline at 6 weeks.(week-0, week-3 and week-6)
研究者
Supasuta Leangpanich
Principal Investigator
Thammasat University