Randomized, controlled, open-label, multi-center trial to compare the efficacy and safety of three herbal medicinal products in the treatment of acute bronchitis

Conditions

Acute bronchitis

Brief summary

Change of BSS between visit V1 (baseline) and visit V6 (7 days of treatment)

Detailed description

Change of BSS between visit V1 (baseline) and each post-baseline visit V2, V3, V4, V5, V7, and V8 as well as baseline adjusted AUC, BSS at each post-baseline visits V2 to V8 and change of BSS between visit V1 (baseline) and post-baseline visits V2, V3, V4, V5, V7, and V8, and related AUCs, CS assessed on VAS between visit V1 (baseline) and post-baseline visits (Area under the curve (AUC) generated with VAS values between visit V1 (baseline) and post-baseline visits V2, V3, V4, V5, V6, V7, and V8 as well as baseline adjusted AUC), CS assessed on VAS at each post-baseline visit and change of CS-VAS between visit V1 (baseline) and post-baseline visits, and related AUCs., Change in CS assessed by VCD score between visit V1 (baseline) and each post-baseline visit V2, V3, V4, V5, V6, V7, and V8, Global efficacy (scores of a 5-point Likert scale by patient and investigator) at post-baseline visits V6, V7 and V8

Related papers

No related papers found yet.

Interventions

DRUGBronchicum Tropfen 43

DRUG4 g Thymiankraut-Fluidextrakt und 21

DRUG7 g Primelwurzeltinktur / 100 ml Flüssigkeit

DRUGBronchipret® Tropfen Flüssigkeit zum Einnehmen Wirkstoffe: Fluidextrakt aus Thymiankraut Fluidextrakt aus Efeublättern

DRUGProspan® Hustentropfen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change of BSS between visit V1 (baseline) and visit V6 (7 days of treatment)	—

Secondary

Measure	Time frame
Change of BSS between visit V1 (baseline) and each post-baseline visit V2, V3, V4, V5, V7, and V8 as well as baseline adjusted AUC, BSS at each post-baseline visits V2 to V8 and change of BSS between visit V1 (baseline) and post-baseline visits V2, V3, V4, V5, V7, and V8, and related AUCs, CS assessed on VAS between visit V1 (baseline) and post-baseline visits (Area under the curve (AUC) generated with VAS values between visit V1 (baseline) and post-baseline visits V2, V3, V4, V5, V6, V7, and V8 as well as baseline adjusted AUC), CS assessed on VAS at each post-baseline visit and change of CS-VAS between visit V1 (baseline) and post-baseline visits, and related AUCs., Change in CS assessed by VCD score between visit V1 (baseline) and each post-baseline visit V2, V3, V4, V5, V6, V7, and V8, Global efficacy (scores of a 5-point Likert scale by patient and investigator) at post-baseline visits V6, V7 and V8	—

Measure

Time frame

Change of BSS between visit V1 (baseline) and each post-baseline visit V2, V3, V4, V5, V7, and V8 as well as baseline adjusted AUC, BSS at each post-baseline visits V2 to V8 and change of BSS between visit V1 (baseline) and post-baseline visits V2, V3, V4, V5, V7, and V8, and related AUCs, CS assessed on VAS between visit V1 (baseline) and post-baseline visits (Area under the curve (AUC) generated with VAS values between visit V1 (baseline) and post-baseline visits V2, V3, V4, V5, V6, V7, and V8 as well as baseline adjusted AUC), CS assessed on VAS at each post-baseline visit and change of CS-VAS between visit V1 (baseline) and post-baseline visits, and related AUCs., Change in CS assessed by VCD score between visit V1 (baseline) and each post-baseline visit V2, V3, V4, V5, V6, V7, and V8, Global efficacy (scores of a 5-point Likert scale by patient and investigator) at post-baseline visits V6, V7 and V8

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Countries

Germany

Outcome results

None listed