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

Phase 2

Completed

• Conditions: Adverse Drug Event; Allergic Rhinitis; Quality of Life
• Interventions: Drug: Prapchompoothaweep remedy; Drug: Loratadine 10 Mg

• Registration Number: NCT03640273
• Lead Sponsor: Thammasat University

Brief 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. 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 Timeline

• Study Start: 2017-11-23
• Primary Completion: 2018-01-04
• Study Completion: 2018-06-24
• Study First Submitted: 2018-07-09
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-19
• Last Update Submitted: 2018-08-20
• Study First Posted: 2018-08-21
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prapchompoothaweep	Prapchompoothaweep remedy	Group 1 will be received Prapchompoothaweep remedy 1,000 mg for 3 times before meals (for 6 weeks).
Loratadine	Loratadine 10 Mg	Group 2 will be received Loratadine 10 mg per day before meals (for 6 weeks)

Primary Outcome Measures

Name	Time	Method
Nasal cavity Change from baseline at 6 weeks	week-0, week-3 and week-6	Using an Acoustic Rhinometry to evaluate nasal symptoms

Secondary Outcome Measures

Name	Time	Method
Liver Function Change from baseline at 6 weeks.	week-0, week-3 and week-6	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.
Renal Function Change from baseline at 6 weeks.	week-0, week-3 and week-6	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.
Assessment of well-being of volunteer that change from baseline at 6 weeks.	week-0, week-3 and week-6	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.	week-0, week-3 and week-6	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.

Trial Locations

Locations (1)

Thammasat University; 🇹🇭 Khlong Luang, Pathumthani, Thailand