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Completed

NCT Number: NCT03640273

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

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.

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Key information

Conditions

Allergic Rhinitis Adverse Drug Event Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Quality of Life Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Thammasat University

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prapchompoothaweep remedy

Drug

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

Loratadine 10 Mg

Drug

Take Loratadine 10 mg once a day before meals.

Primary outcomes

  1. Nasal cavity Change from baseline at 6 weeks

    Time frame: week-0, week-3 and week-6

    Using an Acoustic Rhinometry to evaluate nasal symptoms

Secondary outcomes

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

    Time frame: 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.

  2. Nasal symptoms Change from baseline at 6 weeks.

    Time frame: 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.

  3. Renal Function Change from baseline at 6 weeks.

    Time frame: 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.

  4. Liver Function Change from baseline at 6 weeks.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2018
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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