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

Thammasat University

Status and phase: Completed; Phase 2

Conditions: Adverse Drug Event; Quality of Life; Allergic Rhinitis

Treatments: Drug: Loratadine 10 Mg; Drug: Prapchompoothaweep remedy

Study type: Interventional

Funder types: Other

Identifiers

NCT03640273

Thammasat

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Prapchompoothaweep

Experimental group

Description:

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

Treatment:

Drug: Prapchompoothaweep remedy

Loratadine

Experimental group

Description:

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

Treatment:

Drug: Loratadine 10 Mg