Efficacy and Safety of Bojungikgi-tang for Persistent Allergic Rhinitis: Study Protocol for a Randomized, Double-blind, Placebo-controlled, Phase II Trial
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0006616
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 105
1. Men and women aged 19 ~ 65 years
2. Subjects who had a history of perennial allergic rhinitis for at least 2 years prior to study participation
3. Subjects who had positive reactions to perennial allergens in allergy skin tests (e.g., skin prick test or intradermal test), MAST, or ImmunoCAP that were conducted within 12 months
However, the criteria for positive responses to specific allergens in the prick test, intradermal test, Mmultiple allergen Simultaneous Test,MAST) , or ImmunoCAP are defined as follows.
- Prick tests: a wheal size of = 3 mm, compared with the diluent control
- Intradermal tests: a wheal size of = 7 mm, compared with the diluent control
- MAST or ImmunoCAP: = Class 2
4. Subjects who had an average daily reflective Total Nasal Symptom Score(r-TNSS) of = 5 (maximum=12) at Visit 3 during the 1-week run-in period
5. Subjects who had the ability and willingness to record subject diaries
6. Subjects who agreed to equally maintain surrounding environment during the entire period of the clinical study
7. Subjects who voluntarily agreed to participate in this clinical study in written form
1. non-allergic (angioneurotic, infectious, and drug-induced) rhinitis
2. presence of asthma
3. clinically significant nasal deformities, such as obstructive nasal polyps or nasal septum
4. experienced damages around the nasal cavity or surgeries within 12 weeks
5. the past medical history of acute or chronic sinusitis within 4 weeks
6. initiated immunotherapy or changes in dosage within 4 weeks
7. experienced use of long-acting antihistamines
8. upper respiratory tract infections including the common cold, and systemic infections within 2 weeks
9. comorbidities that may interrupt the treatment of cancers or clinical significant disorders of the kidney, liver, psychiatric system, cardiovascular system, respiratory system, endocrine system, and central nervous system, the safety assessment, or completion of this clinical study
10. abnormal renal function (Creatinine values = 2 times the upper limit of normal)
11. severe abnormal liver function tests (Alanine transaminase (ALT) or Aspartate transaminase (AST) values = 2 times the upper limit of normal)
12. hepatitis A (active) or hepatitis B (active) or hepatitis C
13. unregulated hypertension (high blood pressure of 180 mmHg in the condenser or high blood pressure exceeding 100 mmHg in the relaxation period)
14. electrolyte abnormalities (K test readings outside normal range)
15. hypokalemia or administering drugs (such as furosemide, thiazide, amphotericin, cisplatin, digitalis, etc.) or a condition that can show hypokalemia (such as hypomagnesemia, Bartter syndrome, Gitelman syndrome, etc.) that can cause this
16. anticoagulants (heparin, warfarin, aspirin, etc.) for cardiovascular disorders or blood coagulation disorders,
17. blood coagulation abnormalities (PT-INR, aPTT readings outside normal range)
18. the use of concomitant medications, or those who are expected to need the use of prohibited concomitant medications during the period of the clinical study with the exception of the case that the following minimal period after the use of concomitant medications passed. [nasal passages, topical, eye drops or systemic antihistamines: 3 days (However, 10 days for long-acting agents (e.g., loratadine, fexofenadine, and cetirizine), 14 days for ketotifen, and 3 months for astemizole), cromolyn nasal, or nedocromil: 14 days, anticholinergic: 3 days, nasal or systemic decongestants: 3 days, nasal or systemic corticosteroids: 30 days, reserpine: 3 days, antitussives and expectorants: 3 days, leukotriene modifiers: 7 days, systemic antibiotics: 14 days, nonsteroidal anti-inflammatory drugs (NSAIDs): 2 days (However, a low-dose aspirin (below 100mg) can be used), traditional herbal medicinal products that may affect rhinitis and eye symptoms: 14 days]
19. chronically used tricycle antidepressants, beta-agonists, and bronchodilators that may affect the efficacy of test drugs
20. r-TNSS during the baseline period within 1 week of visit 3 was recorded for less than 4 days
21. plan of long-term movement to other areas during the period of the clinical study
22. history of excessive alcohol use or drug addiction
23. history of hypersensitivity reaction to active ingredients or excipients of the investigational product
24. genetic disorders, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
25. subjects who did not agree to use contraception by medically permitted methods (e.g., surgical treatment of infertility, intrauterine device, c
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in total r-TNSS(Reflective TNSS) score for 4 weeks compared to baseline
- Secondary Outcome Measures
Name Time Method Changes in total r-TNSS(Reflective TNSS) score for 1-2 weeks(2 weeks), 3-4 weeks(2 weeks) compared to baseline;Changes in total i-TNSS(Instantaneous TNSS) score for 1-2 weeks(2 weeks), 3-4 weeks(2 weeks) compared to baseline;Changes in total i-TNSS(Instantaneous TNSS) score for 4 weeks compared to baseline;Changes in KARQLQ score at 2 weeks and 4 weeks compared to baseline;Changes in total IgE and eosinophil count at 4 weeks compared to baseline;subject's assessment of overall treatment after 4 weeks;Changes in r-TNSS(Reflective TNSS) score at 2 weeks and 4 weeks compared to baseline by Korean pattern identification;Changes in r-TNSS(Reflective TNSS) score at 2 weeks and 4 weeks compared to baseline by Sasang Constitution