Clinical trial NCT03640273: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Adverse Drug Event
Quality of Life
Keywords: Loratadine
Prapchompoothaweep
Allergic rhinitis
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Nasal cavity Change from baseline at 6 weeks
timeFrame: week-0, week-3 and week-6
Secondary outcomes:
measure: Assessment of well-being of volunteer that change from baseline at 6 weeks.
timeFrame: week-0, week-3 and week-6
measure: Nasal symptoms Change from baseline at 6 weeks.
timeFrame: week-0, week-3 and week-6
measure: Renal Function Change from baseline at 6 weeks.
timeFrame: week-0, week-3 and week-6
measure: Liver Function Change from baseline at 6 weeks.
timeFrame: week-0, week-3 and week-6
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University
state: Pathumthani
Study officials:
References: