Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients

NCT03376594 | Completed Phase 2 DMC

• 1 other identifier: MTU-EC-TM-4-183/57
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To study the safety and side effects of Benjakul extract capsules 300 mg per day and Loratadine drug for allergic rhinitis patients.

Conditions

Allergic Rhinitis

Keywords

Benjakul Extract; Allergic Rhinitis; Herbal Medicine

Outcome Measures

Primary Outcomes (1)

• Nasal clavity

  efficacy of the treatments on nasal symptoms and clavity by acoustic rhinometry

  42 days

Secondary Outcomes (2)

• Adverse event

  42 days

• Quality of life

  42 days

Study Arms (2)

Benjakul Extract

ACTIVE COMPARATOR

Benjakul Extract 100 mg capsule by mouth 3 times a day for 42 days

Drug: Benjakul Extract

Loratadine

PLACEBO COMPARATOR

Loratadine 10 mg capsule by mouth 3 times a day for 42 days

Drug: Loratadine

Interventions

Benjakul Extract DRUG

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

Also known as: Benjakul remedy

Benjakul Extract

Loratadine DRUG

30 patients taking Loratadine dosage 10 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.

Also known as: Clarityne

Loratadine

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Faculty of Medicine

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Loratadine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Katanchalee Houngiam, M.Sc.

  katanchalee01@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Medicine

Model Details: RCT

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: December 18, 2017
• Study Start: July 30, 2017
• Primary Completion: February 1, 2018
• Study Completion: March 31, 2018
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

TH (1)