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

Pharmacological actions and clinical evaluation of a Chinese Herbal formula in the treatment of seasonal allergic rhinitis: A double blind, randomized, placebo-controlled trial.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000209897

Enrollment

104

Registered

2012-02-20

Start date

2003-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Subjects were required to take two capsules each time, three times daily (with four hours interval) for a period of eight weeks. Each capsule contained 500 mg of a mixture of granules of either herbal medicine (Koda Internationals Pty Ltd, Lane Cove, N.S W. Australia) or placebo ingredient (rice starch from Sigma Pharmaceuticals Pty Ltd (Melbourne, Victoria, Australia). The capsules were prepared by a TGA approved Good Manufacturing Practice (GMP) certified manufacturer (GMP Pharmaceuticals Pty Ltd Girraween, N.S.W. Australia). The two types of capsules were identical in weight and appearance.

Interventions

Astragalus membranaceus (Fisch.) Bge Bupleurum chinense D.C Glycyrrhiza uralensis (Fisch.) Magnolia liliflora (Desr.) Mentha haplocalyx Briq. Schizonepeta Tenuifolia Briq. Saposhnikovia divaricata (Turcz.) Scutellaria baicalensis Georgi. two capsules each time, three times daily (with four hours interval) for a period of eight weeks durong the pollen season (semtember-December). Each capsule contained 500 mg of a mixture of granules of either herbal medicine (Koda Internationals Pty Ltd, Lan

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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.

Outcome results