Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients
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|ClinicalTrials.gov Identifier: NCT03376594|
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : April 26, 2018
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis||Drug: Benjakul Extract Drug: Loratadine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||RCT|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||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.|
|Official Title:||Efficacy and Safety of Benjakul Extract Capsules and Loratadine for Treatment Allergic Rhinitis Patients (Clinical Trial Phase II)|
|Actual Study Start Date :||July 30, 2017|
|Actual Primary Completion Date :||February 1, 2018|
|Actual Study Completion Date :||March 31, 2018|
Active Comparator: Benjakul Extract
Benjakul Extract 100 mg capsule by mouth 3 times a day for 42 days
Drug: Benjakul Extract
30 patients taking Benjakul Extract dosage 100 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.
Other Name: Benjakul remedy
Placebo Comparator: Loratadine
Loratadine 10 mg capsule by mouth 3 times a day for 42 days
30 patients taking Loratadine dosage 10 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.
Other Name: Clarityne
- Nasal clavity [ Time Frame: 42 days ]efficacy of the treatments on nasal symptoms and clavity by acoustic rhinometry
- Adverse event [ Time Frame: 42 days ]Clinical symptoms, Laboratory blood and urine test
- Quality of life [ Time Frame: 42 days ]quality of life of the patientts by Rhinoconjunctivitis quality of life Questionare (Rcq36)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376594
|Faculty of Medicine|
|Khlong Luang, Pathumthani, Thailand, 12120|
|Principal Investigator:||Katanchalee Houngiam, M.Sc.||email@example.com|