Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients

• ClinicalTrials.gov Identifier: NCT03376594
• Recruitment Status: Completed
• First Posted: December 18, 2017
• Last Update Posted: April 26, 2018
• Sponsor: Thammasat University
• Information provided by (Responsible Party): Katanchalee Houngiam, Thammasat University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Allergic Rhinitis	Drug: Benjakul Extract; Drug: Loratadine	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• 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.
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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	Drug: Loratadine; 30 patients taking Loratadine dosage 10 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.; Other Name: Clarityne

Outcome Measures

Primary Outcome Measures :

1. Nasal clavity [ Time Frame: 42 days ]
   efficacy of the treatments on nasal symptoms and clavity by acoustic rhinometry

Secondary Outcome Measures :

1. Adverse event [ Time Frame: 42 days ]
   Clinical symptoms, Laboratory blood and urine test
2. Quality of life [ Time Frame: 42 days ]
   quality of life of the patientts by Rhinoconjunctivitis quality of life Questionare (Rcq36)

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Thailand

Faculty of Medicine

Khlong Luang, Pathumthani, Thailand, 12120

Sponsors and Collaborators

Thammasat University

Investigators

• Principal Investigator: Katanchalee Houngiam, M.Sc.; katanchalee01@gmail.com

More Information

• Responsible Party: Katanchalee Houngiam, Faculty of Medicine, Thammasat University
• ClinicalTrials.gov Identifier: NCT03376594
• Other Study ID Numbers: MTU-EC-TM-4-183/57
• First Posted: December 18, 2017
• Last Update Posted: April 26, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: efficacy : (questionnaire, RCQ 36) safety : (Live function test, renal function test, CBC, BP)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katanchalee Houngiam, Thammasat University:

Benjakul Extract; Allergic Rhinitis; Herbal Medicine

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Loratadine; Antipruritics; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs