Efficacy and Safety of Bojungikgi-Tang for Persistent Allergic Rhinitis: A Randomized, Double-Blinded, Placebo-Controlled, Phase II Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Design and Procedures
2.2. Participants
2.3. Sample Size
2.4. Randomization and Blinding
2.5. Interventions
2.6. Outcomes
2.6.1. Primary Outcome
2.6.2. Secondary Outcomes
2.6.3. Safety Assessment
2.7. Statistical Analysis
3. Results
3.1. Participants
3.2. Total Nasal Symptom Score
3.3. Korean Allergic Rhinitis-Specific Quality of Life Questionnaire
3.4. Total IgE and Eosinophil Counts
3.5. Overall Assessment
3.6. Pattern Identification for AR
3.7. Sasang Constitution
3.8. Safety Assessment
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Botanical Name | Latin Name | Amount (g) |
---|---|---|
Atractylodes macrocephala Koidzumi | Atractylodis Rhizoma Alba | 0.665 |
Panax ginseng C.A.Meyer | Ginseng Radix | 0.665 |
Astragalus membranaceus Bunge | Astragali Radix | 0.665 |
Angelica gigas Nakai | Angelicae Gigantis Radix | 0.500 |
Citrus reticulata Blanco | Citri Unshius Pericarpium | 0.335 |
Bupleurum falcatum Linné | Bupleuri Radix | 0.335 |
Zizyphus jujuba Miller var. inermis Rehder | Zizyphi Fructus | 0.335 |
Glycyrrhiza uralensis Fischer | Glycyrrhizae Radix et Rhizoma | 0.250 |
Cimicifuga heracleifolia Komarov | Cimicifugae Rhizoma | 0.165 |
Zingiber officinale Roscoe | Zingiberis Rhizoma | 0.085 |
High-Dose BJIGT (n = 35) | Standard-Dose BJIGT (n = 35) | Placebo (n = 35) | p-Value | |
---|---|---|---|---|
Age (years) † | 36.74 ± 12.78 | 34.74 ± 11.93 | 33.03 ± 11.47 | 0.4391 |
Sex (N, male/female) § | 14/21 | 14/21 | 14/21 | 1.000 |
Weight (kg) † | 64.39 ± 11.85 | 66.58 ± 12.85 | 67.29 ± 15.29 | 0.6427 |
Height (cm) † | 164.76 ± 8.71 | 166.38 ± 7.13 | 165.67 ± 8.84 | 0.7133 |
r-TNSS † | 6.78 ± 1.49 | 6.15 ± 1.36 | 6.51 ± 1.26 | 0.1632 |
i-TNSS † | 5.35 ± 1.90 | 6.38 ± 1.63 | 5.87 ± 1.59 | 0.045 |
KARQLQ † | 29.8 ± 10.44 | 28.86 ± 11.85 | 28.63 ± 10.78 | 0.7989 |
Total IgE † | 350.92 ± 621.52 | 222.75 ± 391.71 | 256.75 ± 239.64 | 0.4633 |
Eosinophil Counts † | 205.43 ± 184.44 | 145.54 ± 99.51 | 234.86 ± 181.78 | 0.0639 |
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Lee, S.W.; Woo, S.-C.; Lyu, Y.R.; Yang, W.-K.; Kim, S.-H.; Kim, J.H.; Kim, S.Y.; Kang, W.; Jung, I.C.; Kim, T.; et al. Efficacy and Safety of Bojungikgi-Tang for Persistent Allergic Rhinitis: A Randomized, Double-Blinded, Placebo-Controlled, Phase II Trial. Healthcare 2024, 12, 1017. https://doi.org/10.3390/healthcare12101017
Lee SW, Woo S-C, Lyu YR, Yang W-K, Kim S-H, Kim JH, Kim SY, Kang W, Jung IC, Kim T, et al. Efficacy and Safety of Bojungikgi-Tang for Persistent Allergic Rhinitis: A Randomized, Double-Blinded, Placebo-Controlled, Phase II Trial. Healthcare. 2024; 12(10):1017. https://doi.org/10.3390/healthcare12101017
Chicago/Turabian StyleLee, Su Won, Seong-Cheon Woo, Yee Ran Lyu, Won-Kyung Yang, Seung-Hyung Kim, Je Hyun Kim, Si Yeon Kim, Weechang Kang, In Chul Jung, Taesoo Kim, and et al. 2024. "Efficacy and Safety of Bojungikgi-Tang for Persistent Allergic Rhinitis: A Randomized, Double-Blinded, Placebo-Controlled, Phase II Trial" Healthcare 12, no. 10: 1017. https://doi.org/10.3390/healthcare12101017
APA StyleLee, S. W., Woo, S.-C., Lyu, Y. R., Yang, W.-K., Kim, S.-H., Kim, J. H., Kim, S. Y., Kang, W., Jung, I. C., Kim, T., & Park, Y. C. (2024). Efficacy and Safety of Bojungikgi-Tang for Persistent Allergic Rhinitis: A Randomized, Double-Blinded, Placebo-Controlled, Phase II Trial. Healthcare, 12(10), 1017. https://doi.org/10.3390/healthcare12101017