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

NCT03640273 | Completed Phase 2

• 1 other identifier: Thammasat
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate the safety and adverse effect of Prapchompoothaweep crude drug at 3,000 mg and Loratadine 10 mg for Allergic Rhinitis patients.

Conditions

Allergic Rhinitis; Adverse Drug Event; Quality of Life

Keywords

Loratadine; Prapchompoothaweep; Allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Nasal cavity Change from baseline at 6 weeks

  Using an Acoustic Rhinometry to evaluate nasal symptoms

  week-0, week-3 and week-6

Secondary Outcomes (4)

• Assessment of well-being of volunteer that change from baseline at 6 weeks.

  week-0, week-3 and week-6

• Nasal symptoms Change from baseline at 6 weeks.

  week-0, week-3 and week-6

• Renal Function Change from baseline at 6 weeks.

  week-0, week-3 and week-6

• Liver Function Change from baseline at 6 weeks.

  week-0, week-3 and week-6

Study Arms (2)

Prapchompoothaweep

EXPERIMENTAL

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

Drug: Prapchompoothaweep remedy

Loratadine

EXPERIMENTAL

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

Drug: Loratadine 10 Mg

Interventions

Prapchompoothaweep remedy DRUG

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

Prapchompoothaweep

Loratadine 10 Mg DRUG

Take Loratadine 10 mg once a day before meals.

Loratadine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Drug-Related Side Effects and Adverse Reactions

Interventions

Loratadine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Record Dates

• First Submitted: July 9, 2018
• First Posted: August 21, 2018
• Study Start: November 23, 2017
• Primary Completion: January 4, 2018
• Study Completion: June 24, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

TH (1)