Synapse
⌘+K
Synapse
PulseExploreClubsResearchersJournals
Instagram
HomeClubsExplore
August 17, 2023Frontiers in Cardiovascular MedicineOpen Access

Efficacy and safety of Qixue Tongzhi Granule in improving the exercise capacity of stable coronary artery disease: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial

View Full Paper
Ask AI
Bookmark
Share

Key result

Planned RCT evaluates Qixue Tongzhi Granule for improving exercise capacity and prognosis in stable CAD.

  • n=150

Why the study?

Patients with stable coronary artery disease remain at high risk of recurrent cardiovascular events despite optimal medical therapy, and the efficacy and safety of Qixue Tongzhi Granule on exercise capacity and clinical outcomes require evaluation.

Does Qixue Tongzhi Granule improve metabolic equivalents measured by CPET in patients with stable coronary artery disease?

Population

150 SCAD patients with qi deficiency, blood stasis, and liver qi stagnation syndrome

Comparison

Qixue Tongzhi Granule vs placebo, added to guideline-directed medical therapy

Design

Multicenter, randomized, double-blind, placebo-controlled trial

Follow-up

12 weeks of treatment plus 24 weeks of follow-up

Authors

TCTiantian ChaoJSJinghui SunNHNa Huan

Discussion

Loading...

Member takes

Overview

This study protocol outlines a planned trial to evaluate whether Qixue Tongzhi Granule improves exercise capacity in patients with stable coronary artery disease.

Study Design

Type

RCT (n=150)

Blinding

Double-blind

Randomization

center-stratified block randomization

Multicenter

Yes

Structured PICO

Does Qixue Tongzhi Granule improve metabolic equivalents measured by CPET in patients with stable coronary artery disease?

P
Population
A planned trial of 150 adults aged 18-75 with stable coronary artery disease and specific traditional Chinese medicine syndromes, to be followed for 24 weeks.
I
Intervention
Qixue Tongzhi Granule (QTG) added to modern guideline-directed medical therapy for 12 weeks
C
Comparator
Placebo added to modern guideline-directed medical therapy for 12 weeks
O
Outcome
Improvement of metabolic equivalents measured by cardiopulmonary exercise testing (CPET)surrogate

This study protocol outlines a planned trial to evaluate whether Qixue Tongzhi Granule improves exercise capacity in patients with stable coronary artery disease.

Limitations

  • The relatively short duration of follow-up (24 weeks) may be difficult to observe the occurrence of major adverse cardiovascular events.
  • The manufacturers of CPET equipment at the four centers are not in full accordance with each other, which may introduce measurement bias.

Cite This Study

Chao et al. (2023) conducted an RCT in stable coronary artery disease (n=150). Qixue Tongzhi Granule vs. Placebo was evaluated on Improvement of metabolic equivalents (METs) measured by cardiopulmonary exercise testing (CPET). Qixue Tongzhi Granule will be evaluated for its efficacy and safety in improving exercise capacity and long-term prognosis in patients with stable coronary artery disease in this planned randomized controlled trial.

synapsesocial.com/papers/6aa8cab8bf083a602da42519https://doi.org/10.3389/fcvm.2023.1186018
View Full Paper
Ask AI
Bookmark
Share

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1[Chinese expert consensus on standardized clinical application of cardiopulmonary exercise testing].2022 · 11 citations
  2. 2Angina and Future Cardiovascular Events in Stable Patients With Coronary Artery Disease: Insights From the Reduction of Atherothrombosis for Continued Health (REACH) Registry2016 · 82 citations
  3. 32023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease2023 · 554 citations
  4. 4Initial Invasive or Conservative Strategy for Stable Coronary Disease2020 · 2,463 citations
  5. 5Improvement of Fatigue Symptoms and Endurance Capacity by the Combined Administration of <i>Cervus elaphus</i> L., <i>Angelica gigas</i> Nakai, and <i>Astragalus membranaceus</i> Bunge2021 · 7 citations