Allergic Rhinitis Clinical Trial
Official title:
Efficacy and Safety of Benjakul Extract Capsules and Loratadine for Treatment Allergic Rhinitis Patients (Clinical Trial Phase II)
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.
1. Group 1consists of 30 patients, taking Benjakul dosage 100 mg or 1 capsule 3 times
daily. beforeBreakfast, lunch and dinner.
2. 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.
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