Efficacy and Adverse Effects of Prapchompoothaweep Remedy and Loratadine for Treatment in AR Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Study of Efficacy and Adverse Effects of Prapchompoothaweep Remedy Crude Drug and Loratadine for Treatment in Allergic Rhinitis Patients (Clinical Trials Phase II)

Conditions
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Allergic Rhinitis, Adverse Drug Event, Quality of Life

Intervention / Treatment
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* Drug: Prapchompoothaweep remedy
* Drug: Loratadine 10 Mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prapchompoothaweep<br>Group 1 will be received Prapchompoothaweep remedy 1,000 mg for 3 times before meals (for 6 weeks). | Drug: Prapchompoothaweep remedy<br>* Take Prapchompoothaweep remedy capsule at 1,000 mg for 3 times a day before meals.<br>|
| Experimental: Loratadine<br>Group 2 will be received Loratadine 10 mg per day before meals (for 6 weeks) | Drug: Loratadine 10 Mg<br>* Take Loratadine 10 mg once a day before meals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal cavity Change from baseline at 6 weeks | Using an Acoustic Rhinometry to evaluate nasal symptoms | week-0, week-3 and week-6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | week-0, week-3 and week-6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinitis, Loratadine, Prapchompoothaweep