Efficacy and safety of Triphala remedy versus cetirizine in mild persistent allergic rhinitis: A preliminary study

Phase 2

• Conditions: Mild persistent allergic rhinitis; Persistent allergic rhinitis; Triphala; Terminalia chebula Retz.; Terminalia bellirica Roxb.; Emblica officinalis; Cetirizine

• Registration Number: TCTR20191008005
• Lead Sponsor: Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-08
• Study Completion: 2020-10-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

a)Male and female patients aged 18 to 65 years;
b)Diagnosed with mild persistent allergic rhinitis (PER) according to ARIA guidelines;
c)Positive skin prick test to 1 or more allergens;
d)Total nasal symptom scores between 3-7 scores during the 2 previous weeks and the nasal congestion scores < 2 while other symptom scores < 3;
e)All patients will be informed both verbally and in writing of the possible risks and adverse events that may occur during the study and must sign the written consent forms to participate in the study.

Exclusion Criteria

a)Structural abnormalities of the nose such as nasal septum deviation more than 30% or nasal polyp;
b)Acute or chronic upper respiratory infection within the last 2 weeks;
c)Use of antihistamines within the last week;
d)Use of antileukotrienes within the last 4 weeks;
e)Use of intranasal or systemic decongestants within last 3 days;
f)Use of intranasal or oral corticosteroids within the last 4 weeks;
g)Currently on immunotherapy or receive immunotherapy within 1 year;
h)Receive nasal surgery within 4 weeks;
i)Have a history of asthma;
j)Have a history of diarrhea-predominant irritable bowel syndrome (IBS) or alternating constipation and diarrhea IBS;
k)Have a history of diabetes mellitus;
l)Have a history of cardiovascular disease and receive antiplatelet drugs such as clopidogrel or aspirin;
m)Have a history of hepatic or renal diseases;
n)Have a history of hypersensitivity to cetirizine, its excipients or herbs used in this study;
o)Pregnant or lactating;
p)Have a history of cancer; or
q)Clinically significant abnormalities in blood chemistry and hematology:
oHemoglobin < 9 g/dL
oWhite blood cells < 4,000 per cu. mm.
oPlatelets < 100,000 per cu. mm.
oAlanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase more than 1.5 times of the upper limit of normal
oEstimate glomerular filtration rate < 45 mL/min per 1.73 m2 as of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total nasal symptom scores Every day for 8 weeks The sum of scores (0-3) for each of nasal congestion, sneezing, nasal itching, and rhinorrhea