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Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients

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

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 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

Resource links provided by the National Library of Medicine

Drug Information available for: Loratadine

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




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376594


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

Responsible Party: Katanchalee Houngiam, Faculty of Medicine, Thammasat University
ClinicalTrials.gov Identifier: NCT03376594     History of Changes
Other Study ID Numbers: MTU-EC-TM-4-183/57
First Posted: December 18, 2017    Key Record Dates
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
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
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