Allergic RhinitisPhase 2NCT03640273
Efficacy and Adverse Effects of Prapchompoothaweep Remedy and Loratadine for Treatment in AR Patients
A Phase 2 study testing Prapchompoothaweep remedy and Loratadine 10 Mg in people with Allergic Rhinitis and Adverse Drug Event, run by Thammasat University at 1 site in Thailand.
Trial summary
1. To compare the effectiveness of Prapchompoothaweep crude drug at 3,000 mg per day and Loratadine 10 mg per day for treatment in Allergic Rhinitis patients. (Clinical Trial Phase II) 2. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis, Adverse Drug Event, Quality of Life
- What is being tested?
- Prapchompoothaweep remedy and Loratadine 10 Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- 23 Nov 2017to 24 Jun 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18-70 years old.
- Patients with history of allergic rhinitis based on ARIA guidelines. (itching and nasal obstruction, watery nasal discharge, sneezing ,congestion)
- Patients with moderate allergic rhinitis was diagnosed by physicians.
- Have no nasal septum perforation, nasal polyp or sinus surgery.
- Have no serious medical conditions: Heart disease, Liver disease, Renal disease, Hypertension, Peptic Ulcer and Gastroesophageal reflux disease (GERD), severe Asthma, Tuberculosis.
- Have normal range of Hematology test for Liver and Renal function.
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- No Pregnant or Lactation.
- Do not taking a medicine constantly.
- Volunteers are willing to participate this study.
Who cannot join
- Allergic reactions to Prapchompoothaweep remedy and Loratadine.
- Allergic reaction to dairy products.
- Have severe urticaria and anaphylaxis.
- Have a serious condition of immunodeficiency disease: HIV in the previous month before being recruited in the study.
- Participate in another study.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University
Khlong Luang, Changwat Pathum Thani, 12120
About this study
Official title: The Study of Efficacy and Adverse Effects of Prapchompoothaweep Remedy Crude Drug and Loratadine for Treatment in Allergic Rhinitis Patients (Clinical Trials Phase II)
- To compare the effectiveness of Prapchompoothaweep crude drug at 3,000 mg per day and Loratadine 10 mg per day for treatment in Allergic Rhinitis patients. (Clinical Trial Phase II)
- To evaluate the safety and adverse effect of Prapchompoothaweep crude drug at 3,000 mg and Loratadine 10 mg for Allergic Rhinitis patients.
Read the detailed description
this study is a double blind randomized controlled trial study.
the volunteers will be divided into 2 groups. One is received Prapchompoothaweep crude drug capsule at 1,000 mg 3 times a day before meals and the other is received Loratadine 10 mg per day before meals. it takes 6 weeks to complete the project for each volunteers.
Before enrolling, volunteers will stop using any anti-histamine drug for 1 week (wash-out period). All volunteers will be followed up in the 3rd and 6th week to evaluate the efficacy and adverse effect after received drugs.
The researcher will record characteristic data such as gender, age, BMI, vital signs and symptoms . The adverse effect will be monitored by hematology test e.g. liver function test, renal function test, lipid profile and blood sugar test.
- Conditions
- Allergic Rhinitis, Adverse Drug Event, Quality of Life
- Being tested
- Prapchompoothaweep remedy, Loratadine 10 Mg
- Keywords
- Loratadine, Prapchompoothaweep, Allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prapchompoothaweep remedyDrug
Take Prapchompoothaweep remedy capsule at 1,000 mg for 3 times a day before meals.
Loratadine 10 MgDrug
Take Loratadine 10 mg once a day before meals.
| Study group | Role | What they receive |
|---|---|---|
| Prapchompoothaweep | Experimental | Group 1 will be received Prapchompoothaweep remedy 1,000 mg for 3 times before meals (for 6 weeks). Receives: Drug: Prapchompoothaweep remedy |
| Loratadine | Experimental | Group 2 will be received Loratadine 10 mg per day before meals (for 6 weeks) Receives: Drug: Loratadine 10 Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal cavity Change from baseline at 6 weeks
Using an Acoustic Rhinometry to evaluate nasal symptoms
Measured: week-0, week-3 and week-6
Secondary outcomes (4)
Assessment of well-being of volunteer that change from baseline at 6 weeks.
Using Rhinoconjunctivitis Questionnaire of Life (Thai Version copyright by Chaweewan Bunnag MD) This questionnaire is designed to find out how your health and well-being have been affected by rhinoconjunctivitis. score including 1-5 score; 1 = not at all, 2 = Slightly, 3 = moderately, 4 = A lot and 5 = Extremely.
Measured: week-0, week-3 and week-6
Nasal symptoms Change from baseline at 6 weeks.
Using Total Nasal Symptom Score Questionnaire. This questionnaire is designed to estimate how severe of your nasal symptom. the questionnaire including the question of 4 symptom of Allergic Rhinitis; sneezing, nasal congestion, nasal itching and runny nose. the score was divided in 4 mark, 0-not at all, 1=slightly, 2=moderate,3=severe.
Measured: week-0, week-3 and week-6
Renal Function Change from baseline at 6 weeks.
to evaluate the adverse events by hematology test of renal function which including BUN (mg/dL) and Creatinine (mg/dL). Normal range of BUN and Creatinine are 7.0-18.0 mg/dL and 0.67-1.17 mg/dL respectively.
Measured: week-0, week-3 and week-6
Liver Function Change from baseline at 6 weeks.
to evaluate the adverse events by hematology test of liver function which including AST (U/L), ALT (U/L), Total Alkaline Phosphatase (U/L), total bilirubin (mg/dl), direct-bilirubin (mg/dl), Globulin (g/dl), Albumin (g/dl) and Total protein (g/dl).
Normal range of AST, ALT, Alkaline Phosphatase, total bilirubin, direct-bilirubin, globulin, albumin and total protein are 16-37 U/L, 16-63 U/L, 46-116 U/L, 0.2-1.0 mg/dl, 0.0-0.2 mg/dl, 1.5-3.5 g/dl, 3.4-5.0 g/dl and 6.4-8.2 g/dl respectively.
Measured: week-0, week-3 and week-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start23 Nov 2017
- Primary completion4 Jan 2018
- Study completion24 Jun 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
- this study is a double blind randomized controlled trial study. the volunteers will be divided into 2 groups. One is received Prapchompoothaweep crude drug capsule at 1,000 mg 3 times a day before meals and the other is received Loratadine 10 mg per day before meals. it takes 6 weeks to complete the project for each volunteers. Before enrolling, volunteers will stop using any anti-histamine drug for 1 week (wash-out period). All volunteers will be followed up in the 3rd and 6th week to evaluate the efficacy and adverse effect after received drugs. The researcher will record characteristic data such as gender, age, BMI, vital signs and symptoms . The adverse effect will be monitored by hematology test e.g. liver function test, renal function test, lipid profile and blood sugar test.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supasuta Leangpanich, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640273
- Sponsor's protocol ID
- Thammasat
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Effectiveness (Nasal Cavity, Nasal Score, Well-being) and Safety (Hematology test) of Prapchompoothaweep and Loratadine in Allergic Rhinitis patients.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Efficacy and Adverse Effects of Prapchompoothaweep Remedy Crude Drug and Loratadine for Treatment in Allergic Rhinitis Patients (Clinical Trials Phase II)
- ClinicalTrials.gov ID
- NCT03640273
- Acronym / sponsor ID
- Thammasat
- Conditions
- Allergic Rhinitis, Adverse Drug Event, Quality of Life
- Keywords
- Loratadine, Prapchompoothaweep, Allergic rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 4 Jan 2018 (actual)
- Study completion
- 24 Jun 2018 (actual)
- First posted
- 21 Aug 2018 (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 Prapchompoothaweep crude drug at 3,000 mg per day and Loratadine 10 mg per day for treatment in Allergic Rhinitis patients. (Clinical Trial Phase II)
- To evaluate the safety and adverse effect of Prapchompoothaweep crude drug at 3,000 mg and Loratadine 10 mg for Allergic Rhinitis patients.
Detailed description
this study is a double blind randomized controlled trial study.
the volunteers will be divided into 2 groups. One is received Prapchompoothaweep crude drug capsule at 1,000 mg 3 times a day before meals and the other is received Loratadine 10 mg per day before meals. it takes 6 weeks to complete the project for each volunteers.
Before enrolling, volunteers will stop using any anti-histamine drug for 1 week (wash-out period). All volunteers will be followed up in the 3rd and 6th week to evaluate the efficacy and adverse effect after received drugs.
The researcher will record characteristic data such as gender, age, BMI, vital signs and symptoms . The adverse effect will be monitored by hematology test e.g. liver function test, renal function test, lipid profile and blood sugar test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- this study is a double blind randomized controlled trial study. the volunteers will be divided into 2 groups. One is received Prapchompoothaweep crude drug capsule at 1,000 mg 3 times a day before meals and the other is received Loratadine 10 mg per day before meals. it takes 6 weeks to complete the project for each volunteers. Before enrolling, volunteers will stop using any anti-histamine drug for 1 week (wash-out period). All volunteers will be followed up in the 3rd and 6th week to evaluate the efficacy and adverse effect after received drugs. The researcher will record characteristic data such as gender, age, BMI, vital signs and symptoms . The adverse effect will be monitored by hematology test e.g. liver function test, renal function test, lipid profile and blood sugar test.
| Arm | Type | Receives |
|---|---|---|
| Prapchompoothaweep | Experimental | Drug: Prapchompoothaweep remedyGroup 1 will be received Prapchompoothaweep remedy 1,000 mg for 3 times before meals (for 6 weeks). |
| Loratadine | Experimental | Drug: Loratadine 10 MgGroup 2 will be received Loratadine 10 mg per day before meals (for 6 weeks) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged between 18-70 years old.
- Patients with history of allergic rhinitis based on ARIA guidelines. (itching and nasal obstruction, watery nasal discharge, sneezing ,congestion)
- Patients with moderate allergic rhinitis was diagnosed by physicians.
- Have no nasal septum perforation, nasal polyp or sinus surgery.
- Have no serious medical conditions: Heart disease, Liver disease, Renal disease, Hypertension, Peptic Ulcer and Gastroesophageal reflux disease (GERD), severe Asthma, Tuberculosis.
Key exclusion criteria (5 listed)
- Allergic reactions to Prapchompoothaweep remedy and Loratadine.
- Allergic reaction to dairy products.
- Have severe urticaria and anaphylaxis.
- Have a serious condition of immunodeficiency disease: HIV in the previous month before being recruited in the study.
- Participate in another study.
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 |
|---|---|---|
| Prapchompoothaweep remedyTake Prapchompoothaweep remedy capsule at 1,000 mg for 3 times a day before meals. | Drug | Prapchompoothaweep |
| Loratadine 10 MgTake Loratadine 10 mg once a day before meals. | Drug | Loratadine |
Primary outcome
Nasal cavity Change from baseline at 6 weeks
Time frame: week-0, week-3 and week-6
Using an Acoustic Rhinometry to evaluate nasal symptoms
4 secondary outcomes
Assessment of well-being of volunteer that change from baseline at 6 weeks.
Time frame: week-0, week-3 and week-6
Nasal symptoms Change from baseline at 6 weeks.
Time frame: week-0, week-3 and week-6
Renal Function Change from baseline at 6 weeks.
Time frame: week-0, week-3 and week-6
Liver Function Change from baseline at 6 weeks.
Time frame: week-0, week-3 and week-6
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 22 Aug 2018.
- Individual participant dataSharing planned: Undecided. Effectiveness (Nasal Cavity, Nasal Score, Well-being) and Safety (Hematology test) of Prapchompoothaweep and Loratadine in Allergic Rhinitis patients.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prapchompoothaweep remedy and Loratadine 10 Mg in people with Allergic Rhinitis and Adverse Drug Event, 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 9 inclusion and 5 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 22 Aug 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. 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 cavity Change from baseline at 6 weeks (time frame: week-0, week-3 and week-6). 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 22 Aug 2018.