NCT03009136

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

December 31, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

December 28, 2016

Last Update Submit

March 12, 2017

Conditions

Perennial Allergic Rhinitis

Keywords

Perennial Allergic RhinitisHerbal MedicineKorean MedicineSo-Cheong-Ryong-Tang

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Total Nasal Symptom score

    At baseline, week 2, 4, 8, 12

Secondary Outcomes (4)

  • 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

Study Arms (2)

SCRT group

EXPERIMENTAL

3g, three times a day, each taken before or between meals

Drug: SCRT

placebo group

PLACEBO COMPARATOR

3g, three times a day, each taken before or between meals

Drug: Placebos

Interventions

SCRTDRUG

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)

SCRT group
PlacebosDRUG

is made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT

placebo group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-60 years
  • 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)
  • presence of nasal symptoms more than 2 consecutive years; and
  • positive reaction to the one or more perennial allergen in skin prick test.

You may not qualify if:

  • 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
  • presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening, or partial or complete opacification of the paranasal sinuses)
  • presence of hypertension (systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg)
  • 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))
  • presence of neoplasm, severe systemic inflammation, other systemic disease that affects rhinitis
  • history of drug allergy
  • history of anaphylaxis for allergic tests
  • pregnancy or lactation
  • participation of other clinical study within the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, Seoul, 05278, South Korea

RECRUITING

Related Publications (1)

  • 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: 28963290DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Minhee Kim

    Kyung Hee University Hospital at Gangdong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Youme Ko

CONTACT

822-961-9278iseeymk@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 28, 2016

First Posted

January 4, 2017

Study Start

December 31, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

KR(1)