Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03640273
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Supasuta Leangpanich, Thammasat University

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Adverse Drug Event Quality of Life Drug: Prapchompoothaweep remedy Drug: Loratadine 10 Mg Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 23, 2017
Actual Primary Completion Date : January 4, 2018
Actual Study Completion Date : June 24, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Loratadine

Arm Intervention/treatment
Experimental: Prapchompoothaweep
Group 1 will be received Prapchompoothaweep remedy 1,000 mg for 3 times before meals (for 6 weeks).
Drug: Prapchompoothaweep remedy
Take Prapchompoothaweep remedy capsule at 1,000 mg for 3 times a day before meals.

Experimental: Loratadine
Group 2 will be received Loratadine 10 mg per day before meals (for 6 weeks)
Drug: Loratadine 10 Mg
Take Loratadine 10 mg once a day before meals.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640273


Locations
Layout table for location information
Thailand
Thammasat University
Khlong Luang, Pathumthani, Thailand, 12120
Sponsors and Collaborators
Thammasat University

Layout table for additonal information
Responsible Party: Supasuta Leangpanich, Principal Investigator, Thammasat University
ClinicalTrials.gov Identifier: NCT03640273     History of Changes
Other Study ID Numbers: Thammasat
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Effectiveness (Nasal Cavity, Nasal Score, Well-being) and Safety (Hematology test) of Prapchompoothaweep and Loratadine in Allergic Rhinitis patients.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Supasuta Leangpanich, Thammasat University:
Loratadine
Prapchompoothaweep
Allergic rhinitis

Additional relevant MeSH terms:
Layout table for MeSH terms
Rhinitis
Rhinitis, Allergic
Drug-Related Side Effects and Adverse Reactions
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Chemically-Induced Disorders
Loratadine
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs