Perennial Allergic RhinitisPhase 3NCT03009136
Efficacy and Safety of So-Cheong-Ryong-Tang on Perennial Allergic Rhinitis
A Phase 3 study testing SCRT in people with Perennial Allergic Rhinitis, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
Trial summary
The aim of this study is to investigate the short and long term efficacy and the safety of SCRT treatment for PAR Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- SCRT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Dec 2016to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- history of anaphylaxis for allergic tests
- pregnancy or lactation
- participation of other clinical study within the past 3 months.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul, Seoul, 05278
Youme Ko, MD(TCM), 82-2-961-9278, meyougo@khu.ac.kr
Minhee Kim
About this study
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
The aim of this study is to investigate the short and long term efficacy and the safety of SCRT treatment for PAR
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- SCRT, Placebos
- Keywords
- Perennial Allergic Rhinitis, Herbal Medicine, Korean Medicine, So-Cheong-Ryong-Tang
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
PlacebosDrug
is made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT
| Study group | Role | What they receive |
|---|---|---|
| SCRT group | Experimental | 3g, three times a day, each taken before or between meals Receives: Drug: SCRT |
| placebo group | Placebo comparator | 3g, three times a day, each taken before or between meals Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Total Nasal Symptom score
Measured: At baseline, week 2, 4, 8, 12
Secondary outcomes (4)
Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
Measured: At baseline, week 2, 4, 8, 12
Change from baseline in Total serum IgE level
Measured: At baseline, week 4
Change from baseline in eosinophil count
Measured: At baseline, week 4
Change from baseline in cytokine level
Measured: At baseline, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start31 Dec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyung Hee University Hospital at Gangdong
- Sponsor type
- University, hospital or other
- Collaborators
- Kyung Hee University Hospital, Pusan National University Hospital, Semyung University Affiliated Oriental Medical Hospital, DongGuk University
- Responsible party
- Principal investigator, Minhee Kim, Kyung Hee University Hospital at Gangdong
- Investigators
- Minhee Kim, Principal investigator, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009136
- Sponsor's protocol ID
- ISEE_2015_SCRT
- Status last verified
- Mar 2017
- First submitted
- 28 Dec 2016
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28963290
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03009136
- Acronym / sponsor ID
- ISEE_2015_SCRT
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- Perennial Allergic Rhinitis, Herbal Medicine, Korean Medicine, So-Cheong-Ryong-Tang
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Kyung Hee University Hospital at GangdongUniversity, hospital or other
- Collaborators
- Kyung Hee University Hospital, Pusan National University Hospital, Semyung University Affiliated Oriental Medical Hospital, DongGuk University
- Study start
- 31 Dec 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the short and long term efficacy and the safety of SCRT treatment for PAR
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCRT group | Experimental | Drug: SCRT3g, three times a day, each taken before or between meals |
| placebo group | Placebo comparator | Drug: Placebos3g, three times a day, each taken before or between meals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCRTcomposed 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) | Drug | SCRT group |
| Placebosis made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT | Drug | placebo group |
Primary outcome
Change from baseline in Total Nasal Symptom score
Time frame: At baseline, week 2, 4, 8, 12
4 secondary outcomes
Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
Time frame: At baseline, week 2, 4, 8, 12
Change from baseline in Total serum IgE level
Time frame: At baseline, week 4
Change from baseline in eosinophil count
Time frame: At baseline, week 4
Change from baseline in cytokine level
Time frame: At baseline, week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Derived from this study: PubMed 28963290Kim 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.
- Individual participant dataSharing planned: Undecided
Related trials for Perennial Allergic Rhinitis
Active, not recruitingPhase 3
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Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
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A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minhee Kim principal investigator
Kyung Hee University Hospital at Gangdong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SCRT in people with Perennial Allergic Rhinitis, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youme Ko (822-961-9278, iseeymk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Total Nasal Symptom score (time frame: At baseline, week 2, 4, 8, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03009136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.