Back to resultsEfficacy and Adverse Effects of Prapchompoothaweep Remedy and Loratadine for Treatment in AR Patients
Primary Purpose
Allergic Rhinitis, Adverse Drug Event, Quality of Life
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Prapchompoothaweep remedy
Loratadine 10 Mg
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Loratadine, Prapchompoothaweep, Allergic rhinitis
Eligibility Criteria
Inclusion Criteria:
- 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.
- No Pregnant or Lactation.
- Do not taking a medicine constantly.
- Volunteers are willing to participate this study.
Exclusion Criteria:
- 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.
Sites / Locations
- Thammasat University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Prapchompoothaweep
Loratadine
Arm Description
Group 1 will be received Prapchompoothaweep remedy 1,000 mg for 3 times before meals (for 6 weeks).
Group 2 will be received Loratadine 10 mg per day before meals (for 6 weeks)
Outcomes
Primary Outcome Measures
Nasal cavity Change from baseline at 6 weeks
Using an Acoustic Rhinometry to evaluate nasal symptoms
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03640273
Brief Title
Efficacy and Adverse Effects of Prapchompoothaweep Remedy and Loratadine for Treatment in AR Patients
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 23, 2017 (Actual)
Primary Completion Date
January 4, 2018 (Actual)
Study Completion Date
June 24, 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
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Adverse Drug Event, Quality of Life
Keywords
Loratadine, Prapchompoothaweep, Allergic rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prapchompoothaweep
Arm Type
Experimental
Arm Description
Group 1 will be received Prapchompoothaweep remedy 1,000 mg for 3 times before meals (for 6 weeks).
Arm Title
Loratadine
Arm Type
Experimental
Arm Description
Group 2 will be received Loratadine 10 mg per day before meals (for 6 weeks)
Intervention Type
Drug
Intervention Name(s)
Prapchompoothaweep remedy
Intervention Description
Take Prapchompoothaweep remedy capsule at 1,000 mg for 3 times a day before meals.
Intervention Type
Drug
Intervention Name(s)
Loratadine 10 Mg
Intervention Description
Take Loratadine 10 mg once a day before meals.
Primary Outcome Measure Information:
Title
Nasal cavity Change from baseline at 6 weeks
Description
Using an Acoustic Rhinometry to evaluate nasal symptoms
Time Frame
week-0, week-3 and week-6
Secondary Outcome Measure Information:
Title
Assessment of well-being of volunteer that change from baseline at 6 weeks.
Description
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.
Time Frame
week-0, week-3 and week-6
Title
Nasal symptoms Change from baseline at 6 weeks.
Description
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.
Time Frame
week-0, week-3 and week-6
Title
Renal Function Change from baseline at 6 weeks.
Description
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.
Time Frame
week-0, week-3 and week-6
Title
Liver Function Change from baseline at 6 weeks.
Description
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.
Time Frame
week-0, week-3 and week-6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
No Pregnant or Lactation.
Do not taking a medicine constantly.
Volunteers are willing to participate this study.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Thammasat University
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
Effectiveness (Nasal Cavity, Nasal Score, Well-being) and Safety (Hematology test) of Prapchompoothaweep and Loratadine in Allergic Rhinitis patients.
Learn more about this trial
Efficacy and Adverse Effects of Prapchompoothaweep Remedy and Loratadine for Treatment in AR Patients
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