Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis

NCT03009136 — Phase 3, Unknown, 154 participants, Kyung Hee University Hospital at Gangdong

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Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis: Study Protocol for a Double-blind, Randomized, Parallel-group, Multi-center Trial

Registry	NCT03009136
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	154 (Estimated)
Sponsor	Kyung Hee University Hospital at Gangdong (Other); collaborators: Kyung Hee University Hospital, Pusan National University Hospital, Semyung University Affiliated Oriental Medical Hospital, DongGuk University
Conditions	Perennial Allergic Rhinitis
Interventions	SCRT, Placebos (Drug)
Dates	start 2016-12-31, primary completion 2018-12-01 (estimated), completion 2018-12-01 (estimated), first posted 2017-01-04, last updated 2017-03-14
Locations	1 site in South Korea

-Summary

The aim of this study is to investigate the short and long term efficacy and the safety of SCRT treatment for PAR

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+Arms and interventions

Arm	Type	Interventions	Description
SCRT group	Experimental	Drug: SCRT	3g, three times a day, each taken before or between meals
placebo group	Placebo comparator	Drug: Placebos	3g, three times a day, each taken before or between meals

SCRT (Drug): composed of eight herbs: Glycyrrhiza uralensis Fischer 1g Zingiber officinale Roscoe 0.5g Cinnamomum cassia Blume 0.2g, Ephedra sinica Stapf 0.5g, Pinellia ternata Breitenbach 2.67g, Paeonia lactiflora PALL 1g, Asiasarum sieboldi F. Maekawa 0.5g, Schisandra chinensis 2.67g (per 9g of granules)
Placebos (Drug): is made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT

+Outcome measures

Primary outcomes

Change from baseline in Total Nasal Symptom score [At baseline, week 2, 4, 8, 12]

Secondary outcomes

Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score [At baseline, week 2, 4, 8, 12]
Change from baseline in Total serum IgE level [At baseline, week 4]
Change from baseline in eosinophil count [At baseline, week 4]
Change from baseline in cytokine level [At baseline, week 4]

+Eligibility

Sex: All, ages: 18 Years to 60 Years

Inclusion Criteria:

1. age 18-60 years
2. presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) with severity score ≥ 2 (0 = no symptom, 1 = mild symptom, 2 = moderate symptom, and 3=severe symptom)
3. presence of nasal symptoms more than 2 consecutive years; and
4. positive reaction to the one or more perennial allergen in skin prick test.

Exclusion Criteria:

1. treatment with nasal/oral corticosteroids within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; or nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week
2. presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening, or partial or complete opacification of the paranasal sinuses)
3. presence of hypertension (systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg)
4. presence of abnormal liver function (aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 100 IU/L) or abnormal renal function (blood urea nitrogen (BUN) ≥ 30 mg/dL or creatinine ≥ 1.8 mg/dL (male), 1.5 mg/dL (female))
5. presence of neoplasm, severe systemic inflammation, other systemic disease that affects rhinitis
6. history of drug allergy
7. history of anaphylaxis for allergic tests
8. pregnancy or lactation
9. participation of other clinical study within the past 3 months.

+Locations (1)

Facility	City	Country	Status
Kyung Hee University Hospital at Gangdong	Seoul, Seoul	South Korea	Recruiting

+Publications

Results publication: Kim MH, Ko Y, Ahn JH, Yun Y, Yun MN, Ko SG, Choi I. Efficacy and safety of So-Cheong-Ryong-Tang in treatment of perennial allergic rhinitis: study protocol for a double-blind, randomised, parallel-group, multicentre trial. BMJ Open. 2017 Sep 27;7(9):e016556. doi: 10.1136/bmjopen-2017-016556. PMID 28963290

+Investigators

Minhee Kim, Principal investigator, Kyung Hee University Hospital at Gangdong

My Notes

Public

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