Clinical trial NCT03376594: Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients
Official title: Efficacy and Safety of Benjakul Extract Capsules and Loratadine for Treatment Allergic Rhinitis Patients (Clinical Trial Phase II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: Benjakul Extract
Allergic Rhinitis
Herbal Medicine
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Nasal clavity
timeFrame: 42 days
Secondary outcomes:
measure: Adverse event
timeFrame: 42 days
measure: Quality of life
timeFrame: 42 days
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Faculty of Medicine
state: Pathumthani
Study officials:
affiliation: katanchalee01@gmail.com
name: Katanchalee Houngiam, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: