Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients

April 24, 2018 updated by: Katanchalee Houngiam, Thammasat University

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

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumthani
      • Khlong Luang, Pathumthani, Thailand, 12120
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Clarityne

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal clavity
Time Frame: 42 days
efficacy of the treatments on nasal symptoms and clavity by acoustic rhinometry
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event
Time Frame: 42 days
Clinical symptoms, Laboratory blood and urine test
42 days
Quality of life
Time Frame: 42 days
quality of life of the patientts by Rhinoconjunctivitis quality of life Questionare (Rcq36)
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 30, 2017

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

March 31, 2018

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (ACTUAL)

December 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-TM-4-183/57

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

efficacy : (questionnaire, RCQ 36) safety : (Live function test, renal function test, CBC, BP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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