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

NCT ID: NCT03640273

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-23
• Study Completion Date: 2018-06-24

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.

Conditions

Allergic Rhinitis; Adverse Drug Event; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prapchompoothaweep

Group 1 will be received Prapchompoothaweep remedy 1,000 mg for 3 times before meals (for 6 weeks).

Group Type: EXPERIMENTAL

Prapchompoothaweep remedy

Intervention Type: DRUG

Take Prapchompoothaweep remedy capsule at 1,000 mg for 3 times a day before meals.

Loratadine

Group 2 will be received Loratadine 10 mg per day before meals (for 6 weeks)

Group Type: EXPERIMENTAL

Loratadine 10 Mg

Intervention Type: DRUG

Take Loratadine 10 mg once a day before meals.

Interventions

Prapchompoothaweep remedy

Take Prapchompoothaweep remedy capsule at 1,000 mg for 3 times a day before meals.

Intervention Type: DRUG

Loratadine 10 Mg

Take Loratadine 10 mg once a day before meals.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thammasat University

OTHER

Sponsor Role: lead

Responsible Party

Supasuta Leangpanich

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Thammasat University

Khlong Luang, Changwat Pathum Thani, Thailand

Countries

Thailand

Other Identifiers

Thammasat

Identifier Type: -

Identifier Source: org_study_id