Efficacy and safety of Chinese herbal medicine (RCM-102) for treatment of seasonal allergic rhinitis (hayfever)

Phase 1

Completed

• Conditions: seasonal allergic rhinitis; Inflammatory and Immune System - Allergies; Respiratory - Other respiratory disorders / diseases; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12612000209897
• Lead Sponsor: Professor Charlie Xua

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

(a) age between 18 to 65 years with two or more symptoms for at least two years with a total nasal symptom score (TNSS) of at least six;
(b) a positive pollen skin prick test (SPT).

Exclusion Criteria

(a) initiated immunotherapy since last SAR season;
(b) HIV positive;
(c) other active respiratory disease within 30 days of study; (d) receiving oral corticosteroid treatment;
(e) pregnancy or lactation;
(f) nasal polyposis; and
(g) unable to read or understand English.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nasal symptoms (sneezing; rhinorrhea; itchy nose; obstruction) and non-nasal symptoms (palate, and/or throat; itchy, watery, red eye) on a 5-point scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe, using a symptoms severity five-point scale, VAS,[Day 1, 14, 28, 42,56,70]

Secondary Outcome Measures

Name	Time	Method
General Quality of Life (SF36)[Day 1, 14, 28, 42,56,70];Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).[Day 14, 28, 42,56,70];Liver and kidney function test[Day 1 and Day 70]