Efficacy and Safety of Benjakul Extract Capsules and Loratadine for Treatment Allergic Rhinitis Patients (Clinical Trial Phase II)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Nasal clavity
研究概览
简要总结
- To compare the effectiveness of Benjakul extract capsules at 300 mg per day with Loratadine drug in the treatment of allergic rhinitis patients in small group (Clinical Trial Phase II).
- To study the safety and side effects of Benjakul extract capsules 300 mg per day and Loratadine drug for allergic rhinitis patients.
详细描述
- Group 1consists of 30 patients, taking Benjakul dosage 100 mg or 1 capsule 3 times daily. beforeBreakfast, lunch and dinner.
- Group 2 consists of 30 patients, taking Loratadine dosage 100 mg 1time daily.Taking drug is as follows
Volunteers will be treated by drugs continuously for a period of six weeks. Taking three times a day 1 tablet before meals (breakfast, lunch, dinner), giving drug based on random.
Volunteers groups receiving Benjakul take 1capsule 3 times daily. Volunteer groups receiving Loratadine take loratadine tablet first 1capsule 1 time daily and then taking placebo once 1 capsule during the day and 1 capsule in the evening.
Patients have to report all the 42 days (6 weeks). The blood and urine samples will be collected and evaluated before the treatment and later following symptoms after 21 and 42 days (3 weeks and 6). Assessment methods to measure the nasal, other of nasal symptoms, assessment of quality of life and overall treatment (Global assessment),Acoustic Rhinometry and tools which are used to evaluate nasal congestion. measuring the narrowest cross-sectional area of the nasal cavity, this tool takes a short time to evaluate and can determine volume of nasal cavity by calculating of the CSA in the nasal cavity. In addition, the researchers areable to check the safety of using medications by taking blood and urine samples to check Hematology CBC, Lipid profile, FBS monitoring of renal function (Renal function test) and liver function tests (Liver Function Tests: LFTs). So, the volunteers must NPO before every blood drawing.
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)
盲法说明
Grouping uses Randomize controlled trial (RCT) and groups by using Random allocation by means of Simple Randomization as well as using the code with BJK followed by 3 digits (BJK001, BJK002, ...) and treating in double blinding form.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients aged between 20-70 years
- •Patients have history of allergic rhinitis on the basis of Allergic Rhinitis and its Impact on Asthma : ARIA (itching and nasal obstruction, watery nasal discharge, sneezing ,congestion)
- •Patients have moderate allergic rhinitis diagnosed by doctor with a minimum TNSS score of 5 points
- •No history of disease : heart disease, kidney disease, liver disease, epilepsy,high blood pressure and severe asthma.
- •Normal results in blood test, liver and kidney.
- •Not pregnant or breastfeeding.
- •Body Mass Index (BMI) 18-35 kg / m2 and normal vital signs.
- •Volunteers are willing participants.
排除标准
- •Volunteers who have taken anti-coagulant and anti-platelet aggregation drugs.
- •Patients receiving Intranasal steroids.
- •Volunteers who get serious side effect from loratadine : fatigue, headache, dry mouth, drowsiness, nausea, stomach ulcers, rash.
- •Volunteers who have side effects from Benjakul drug.
- •Volunteers who have a temperature.
- •Volunteers participating in other research.
- •Volunteers who have severe urticaria and anaphalaxis.
- •Volunteers who are immunocompromised or have with severe chronic diseases, such as AIDS.
- •Volunteers who have taken Macrolides : erythromycin, clarithromycin, Imidazole (ketoconazole, itraconazole, fluconazole) HIV protease Inhibitors, Other drugs that inhibit the enzyme CYP450: cimetidine,metronidazole,zafirlukast, SSRIS
- •Volunteers are using drug which extract QT interval, such as Calcium Channel Blockers (eg bepridil, verapamil), Tricyclic Antidepressant, Cisapride, Quinidine and so on.
- •Volunteers have nasal septum perforation or have had sinus surgery
研究组 & 干预措施
Benjakul Extract
Benjakul Extract 100 mg capsule by mouth 3 times a day for 42 days
干预措施: Benjakul Extract (Drug)
Loratadine
Loratadine 10 mg capsule by mouth 3 times a day for 42 days
干预措施: Loratadine (Drug)
结局指标
主要结局
Nasal clavity
时间窗: 42 days
efficacy of the treatments on nasal symptoms and clavity by acoustic rhinometry
次要结局
- Adverse event(42 days)
- Quality of life(42 days)
研究者
Katanchalee Houngiam
Faculty of Medicine
Thammasat University