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

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ClinicalTrials.gov Identifier: NCT03009136
Recruitment Status : Unknown
Verified March 2017 by Minhee Kim, Kyung Hee University Hospital at Gangdong.
Recruitment status was:  Recruiting
First Posted : January 4, 2017
Last Update Posted : March 14, 2017
Sponsor:
Collaborators:
Kyung Hee University Hospital
Pusan National University Hospital
Semyung University Affiliated Oriental Medical Hospital
DongGuk University
Information provided by (Responsible Party):
Minhee Kim, Kyung Hee University Hospital at Gangdong

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

Condition or disease Intervention/treatment Phase
Perennial Allergic Rhinitis Drug: SCRT Drug: Placebos Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis: Study Protocol for a Double-blind, Randomized, Parallel-group, Multi-center Trial
Actual Study Start Date : December 31, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: SCRT group
3g, three times a day, each taken before or between meals
Drug: SCRT
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)

Placebo Comparator: placebo group
3g, three times a day, each taken before or between meals
Drug: Placebos
is made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT




Primary Outcome Measures :
  1. Change from baseline in Total Nasal Symptom score [ Time Frame: At baseline, week 2, 4, 8, 12 ]

Secondary Outcome Measures :
  1. Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score [ Time Frame: At baseline, week 2, 4, 8, 12 ]
  2. Change from baseline in Total serum IgE level [ Time Frame: At baseline, week 4 ]
  3. Change from baseline in eosinophil count [ Time Frame: At baseline, week 4 ]
  4. Change from baseline in cytokine level [ Time Frame: At baseline, week 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009136


Contacts
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Contact: Youme Ko 822-961-9278 iseeymk@gmail.com

Locations
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Korea, Republic of
Kyung Hee University Hospital at Gangdong Recruiting
Seoul, Korea, Republic of, 05278
Contact: Youme Ko, MD(TCM)    82-2-961-9278    meyougo@khu.ac.kr   
Principal Investigator: Minhee Kim         
Sponsors and Collaborators
Kyung Hee University Hospital at Gangdong
Kyung Hee University Hospital
Pusan National University Hospital
Semyung University Affiliated Oriental Medical Hospital
DongGuk University
Investigators
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Principal Investigator: Minhee Kim Kyung Hee University Hospital at Gangdong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Minhee Kim, Clinical Professor, Kyung Hee University Hospital at Gangdong
ClinicalTrials.gov Identifier: NCT03009136     History of Changes
Other Study ID Numbers: ISEE_2015_SCRT
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Minhee Kim, Kyung Hee University Hospital at Gangdong:
Perennial Allergic Rhinitis
Herbal Medicine
Korean Medicine
So-Cheong-Ryong-Tang

Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases