NCT04163835|UnknownPhase 4DMC
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Sponsor study identifier
interventional
150
1 country
1
Study Start
September 1, 2015
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A Randomized, double-blind, placebo-controlled, four dose groups, post-marketing clinical trial, to evaluate the efficacy and safety of Wenxin granules in treating atrial premature beats by different doses,to provide a scientific basis for rational clinical use of drug.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2015
Actual (reported)October 29, 2019
Actual (reported)November 15, 2019
Actual (reported)December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Responder rate based on 24-hour Holter monitoring.
Defined as the proportion (%) of subjects with a ≥ 50% reduction in atrial premature beats during 24-hour Holter monitoring from baseline.
Week 0 to Week 4
Change in Total Score From Baseline in Traditional Chinese Medicine Syndrome Score Scale.
Week 0 to Week 4
Responder rate(%) based on each symptom score.
Week 0 to Week 4
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Week 0 to Week 4
Impact of treatment on Liver Function
Week 0 to Week 4
Impact of treatment on Renal Function
Week 0 to Week 4
The intervention is half-dose of Wenxin Granules (1/2 normal dose).
The intervention is medium-dose of Wenxin Granules (normal dose).
The intervention is twice-dose of Wenxin Granules (twice normal dose).
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks. Ingredients: Wenxin Granules (no sucrose) 5g + Wenxin Granules placebo 5g.
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks. Ingredients: Wenxin Granules (no sucrose) 2.5g + Wenxin Granules placebo 7.5g.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053, China
Hongli Wu
China Academy of Chinese Medical Sciences
First Submitted
October 29, 2019
First Posted
November 15, 2019
Oral Magnesium Supplementation in Athletes With Premature Ventricular Contractions or Premature Atrial Contractions.
The intervention is a placebo.
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks. Ingredients: Wenxin Granules (no sucrose) 10g.
The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks. Ingredients: Wenxin Granules placebo 10g.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
September 1, 2015
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 18, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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