Skip to main content
Evidence-Based Supplement Research
Evidence-Based Supplement Research
Pillser
Search
Sign UpLog In

The efficacy and safety of DW1601 in patients with acute bronchitis: a multi-center, randomized, double-blind, phase III clinical trial.

  • 2022-09-26
  • The Korean journal of internal medicine 37(6)
    • Young Seok Lee
    • Seong Yong Lim
    • Kyung Hoon Min
    • Do Jin Kim
    • Kwang Ha Yoo
    • Tae-Bum Kim
    • Hak-Ryul Kim
    • Jae Jeong Shim

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 204
Population
204 patients with acute bronchitis
Methods
Randomized, double-blind, placebo-controlled, multi-centre trial, 1:1:1 randomization to receive DW1601, DW16011, or P. sidoides for 7 days
Blinding
Double-blind
Duration
7 days
Funding
Unclear
  • Large Human Trial

Background/aims

DW1601, an oral fixed dose combination syrup composed of DW16011 and Pelargonium sidoides, was developed to enhance the symptom relief effect in patients with acute bronchitis. We evaluated the efficacy and safety of DW1601 compared to DW16011 or P. sidoides for treatment of acute bronchitis using a randomized, double-blind, placebocontrolled, multi-centre trial design.

Methods

A total of 204 patients with acute bronchitis was randomized 1:1:1 to receive DW1601 (n = 67), DW16011 (n = 70), or P. sidoides (n = 64) for 7 days. The primary outcome was efficacy of DW1601 compared to DW16011 or P. sidoides in reducing the total bronchitis severity score (BSS) at day 4 of treatment. Secondary endpoints were changes in total and symptomspecific BSS, response rate and patient satisfaction rate. Safety analysis was assessed at day 7.

Results

At 4 days after medication, decrease of total BSS from baseline was significantly greater in the DW1601 group than in the DW16011 group (-3.51 ± 0.18 vs. -2.65 ± 0.18, p = 0.001) or P. sidoides group (-3.56 ± 0.18 vs. -2.64 ± 0.19, p < 0.001). In addition, the BSS total score at day 7 and the BSS cough and sputum component scores at days 4 and 7 were significantly more improved with DW1601 treatment compared with the DW16011 group or P. sidoides group. Participants treated with DW1601 showed higher rates of response and satisfaction than control groups (response rate, DW1601, 100% vs. DW16011, 85.7% vs. P. sidoides, 85.9%; satisfaction rate, DW1601, 92.6% vs. DW16011, 82.9% vs. P. sidoides, 81.2%). Significant adverse events were not observed in the DW1601 group.

Conclusion

DW1601 is superior to DW16011 or P. sidoides in improving symptoms of acute bronchitis.

Research Insights

  • Geranium→Improved Response Rate

    Participants treated with DW1601 showed higher rates of response and satisfaction than control groups (response rate, DW1601, 100% vs. DW16011, 85.7% vs. P. sidoides, 85.9%

    Effect
    Neutral
    Effect size
    Small
  • Geranium→Improved Satisfaction Rate

    satisfaction rate, DW1601, 92.6% vs. DW16011, 82.9% vs. P. sidoides, 81.2%

    Effect
    Neutral
    Effect size
    Small
  • Geranium→Reduced Bronchitis Severity Score

    At 4 days after medication, decrease of total BSS from baseline was significantly greater in the DW1601 group than in the DW16011 group (-3.51 ± 0.18 vs. -2.65 ± 0.18, p = 0.001) or P. sidoides group (-3.56 ± 0.18 vs. -2.64 ± 0.19, p < 0.001).

    Effect
    Neutral
    Effect size
    Small
  • Geranium→Reduced Cough Severity

    the BSS cough and sputum component scores at days 4 and 7 were significantly more improved with DW1601 treatment compared with the DW16011 group or P. sidoides group.

    Effect
    Neutral
    Effect size
    Small
  • Geranium→Reduced Sputum Severity

    the BSS cough and sputum component scores at days 4 and 7 were significantly more improved with DW1601 treatment compared with the DW16011 group or P. sidoides group.

    Effect
    Neutral
    Effect size
    Small
Back to top