Mild persistent allergic rhinitis Persistent allergic rhinitis Triphala Terminalia chebula Retz. Terminalia bellirica Roxb. Emblica officinalis Cetirizine
Conditions
Interventions
if the patients don’t have any intolerable adverse event,
the patients will take Triphala 6 capsules (450 mg/capsule) two times a day before breakfast and bedtime and placebo of cetirizine 1 tablet once a day before bedtime in week 5-
8 (4 weeks).
Triphala 450 mg tablets consisting of T. chebula,
T. bellirica,
4 (4 weeks). At week 4 (visit 2),
The patients will take Triphala (450 mg/capsule) 3 capsules two times a day before breakfast and bedtime and placebo of cetirizine 1 tablet before bedtime in week 1-
and E. officinalis.,The patients will take placebo of Triphala 3 capsules two times a day before breakfast and bedtime and cetirizine (10mg) 1 tablet before bedtime in week 1-
the patients will take placebo of Triphala 6 capsules two times a day before breakfast and bedtime and cetirizine 1 tablet once a day before bedtime in week 5-
8 (4 weeks).
Experimental Drug,Active Comparator Drug
Triphala,Cetirizine
Sponsors
Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Thailand
Faculty of Medicine,
Chiang Mai University,
Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
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: o Hemoglobin < 9 g/dL o White blood cells < 4,000 per cu. mm. o Platelets < 100,000 per cu. mm. o Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase more than 1.5 times of the upper limit of normal o Estimate glomerular filtration rate < 45 mL/min per 1.73 m2 as of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Global rhinitis symptom 0, 4, and 8 weeks 100-mm visual analog scale ,Patient’s overall opinions on improvement 4 and 8 weeks 100-mm visual analog scale ,Quality of life 0, 4, and 8 weeks Rhinoconjunctivitis quality of life questionnaire (Rcq-36) ,Nasal airflow 0, 4, and 8 weeks Peak nasal inspiratory flow (PNIF) ,Nasal airway resistance 0, 4, and 8 weeks Anterior rhinomanometry ATMOS® Rhino 31 ,Levels of cytokines in nasal lavage fluid 0, 30, and 360 min after NAC ELISA,Nasal decongestant test 360 min after NAC PNIF and anterior rhinomanometry after apply the topical decongestant ,Drug compliance 4 and 8 weeks Count the number of remaining drugs,Safety assessment 4 and 8 weeks A physical examination and non-directive questioning for adverse events ,Diary card recording adverse events Everyday Patients will be asked to record any adverse effects on their diary card,Laboratory tests 0 and 8 weeks Blood test evaluating complete blood count, creatinine level and liver function test | — |
Countries
Thailand
Contacts
Public ContactNutthiya Hanprasertpong
Department of Pharmacology, Faculty of Medicine, Chiang Mai University
Outcome results
None listed