Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients

Allergic Rhinitis Clinical Trial

Official title:

Efficacy and Safety of Benjakul Extract Capsules and Loratadine for Treatment Allergic Rhinitis Patients (Clinical Trial Phase II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376594
• Other study ID #: MTU-EC-TM-4-183/57
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2017
• Last updated: April 24, 2018
• Start date: July 30, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Benjakul Extract
30 patients taking Benjakul Extract dosage 100 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.
• Loratadine
30 patients taking Loratadine dosage 10 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine	Khlong Luang	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal clavity	efficacy of the treatments on nasal symptoms and clavity by acoustic rhinometry	42 days
Secondary	Adverse event	Clinical symptoms, Laboratory blood and urine test	42 days
Secondary	Quality of life	quality of life of the patientts by Rhinoconjunctivitis quality of life Questionare (Rcq36)	42 days