Allergic RhinitisPhase 2NCT03376594
Benjakul Extract and Loratadine for Treatment Allergic Rhinitis Patients
A Phase 2 study testing Benjakul Extract and Loratadine in people with Allergic Rhinitis, run by Thammasat University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Benjakul Extract and Loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 30 Jul 2017to 31 Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine
Khlong Luang, Changwat Pathum Thani, 12120
About this study
Official title: Efficacy and Safety of Benjakul Extract Capsules and Loratadine for Treatment Allergic Rhinitis Patients (Clinical Trial Phase II)
- 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.
Read the 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.
- Conditions
- Allergic Rhinitis
- Being tested
- Benjakul Extract, Loratadine
- Keywords
- Benjakul Extract, Allergic Rhinitis, Herbal Medicine
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benjakul ExtractDrug
Also called Benjakul remedy
30 patients taking Benjakul Extract dosage 100 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.
LoratadineDrug
Also called Clarityne
30 patients taking Loratadine dosage 10 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Benjakul Extract | Active comparator | Benjakul Extract 100 mg capsule by mouth 3 times a day for 42 days Receives: Drug: Benjakul Extract |
| Loratadine | Placebo comparator | Loratadine 10 mg capsule by mouth 3 times a day for 42 days Receives: Drug: Loratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal clavity
efficacy of the treatments on nasal symptoms and clavity by acoustic rhinometry
Measured: 42 days
Secondary outcomes (2)
Adverse event
Clinical symptoms, Laboratory blood and urine test
Measured: 42 days
Quality of life
quality of life of the patientts by Rhinoconjunctivitis quality of life Questionare (Rcq36)
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start30 Jul 2017
- Primary completion1 Feb 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katanchalee Houngiam, Thammasat University
- Investigators
- Katanchalee Houngiam, M.Sc., Principal investigator, katanchalee01@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376594
- Sponsor's protocol ID
- MTU-EC-TM-4-183/57
- Status last verified
- Apr 2018
- First submitted
- 26 Jun 2017
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: efficacy : (questionnaire, RCQ 36) safety : (Live function test, renal function test, CBC, BP)
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Benjakul Extract Capsules and Loratadine for Treatment Allergic Rhinitis Patients (Clinical Trial Phase II)
- ClinicalTrials.gov ID
- NCT03376594
- Acronym / sponsor ID
- MTU-EC-TM-4-183/57
- Conditions
- Allergic Rhinitis
- Keywords
- Benjakul Extract, Allergic Rhinitis, Herbal Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 30 Jul 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Benjakul Extract | Active comparator | Drug: Benjakul ExtractBenjakul Extract 100 mg capsule by mouth 3 times a day for 42 days |
| Loratadine | Placebo comparator | Drug: LoratadineLoratadine 10 mg capsule by mouth 3 times a day for 42 days |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benjakul ExtractAlso: Benjakul remedy30 patients taking Benjakul Extract dosage 100 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days. | Drug | Benjakul Extract |
| LoratadineAlso: Clarityne30 patients taking Loratadine dosage 10 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days. | Drug | Loratadine |
Primary outcome
Nasal clavity
Time frame: 42 days
efficacy of the treatments on nasal symptoms and clavity by acoustic rhinometry
2 secondary outcomes
Adverse event
Time frame: 42 days
Quality of life
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Individual participant dataSharing planned: Undecided. efficacy : (questionnaire, RCQ 36) safety : (Live function test, renal function test, CBC, BP)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katanchalee Houngiam, M.Sc. principal investigator
katanchalee01@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benjakul Extract and Loratadine in people with Allergic Rhinitis, run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal clavity (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.