Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients

• Status: Completed
• Trial end date: 2018-03-31
• Target enrollment: 0
• Participant gender: All

Summary

1. 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).

2. To study the safety and side effects of Benjakul extract capsules 300 mg per day and Loratadine drug for allergic rhinitis patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Thammasat University
• Treatments: Loratadine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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