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Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Benjakul Extract

Loratadine

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Benjakul Extract, Allergic Rhinitis, Herbal Medicine

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Benjakul Extract

Loratadine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Nasal clavity

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

Secondary Outcome Measures

Adverse event

Clinical symptoms, Laboratory blood and urine test

Quality of life

quality of life of the patientts by Rhinoconjunctivitis quality of life Questionare (Rcq36)

Full Information

NCT ID

NCT03376594

First Posted

June 26, 2017

Last Updated

April 24, 2018

Sponsor

Thammasat University

1. Study Identification

Unique Protocol Identification Number

NCT03376594

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

July 30, 2017 (Actual)

Primary Completion Date

February 1, 2018 (Actual)

Study Completion Date

March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Thammasat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

Group 1consists of 30 patients, taking Benjakul dosage 100 mg or 1 capsule 3 times daily. beforeBreakfast, lunch and dinner. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Benjakul Extract, Allergic Rhinitis, Herbal Medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

RCT

Masking

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Benjakul Extract

Arm Type

Active Comparator

Arm Description

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

Arm Title

Loratadine

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Benjakul Extract

Other Intervention Name(s)

Benjakul remedy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Loratadine

Other Intervention Name(s)

Clarityne

Intervention Description

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

Primary Outcome Measure Information:

Title

Nasal clavity

Description

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

Time Frame

42 days

Secondary Outcome Measure Information:

Title

Adverse event

Description

Clinical symptoms, Laboratory blood and urine test

Time Frame

42 days

Title

Quality of life

Description

quality of life of the patientts by Rhinoconjunctivitis quality of life Questionare (Rcq36)

Time Frame

42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katanchalee Houngiam, M.Sc.

Organizational Affiliation

katanchalee01@gmail.com

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine

City

Khlong Luang

State/Province

Pathumthani

ZIP/Postal Code

12120

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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

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Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients

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