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Efficacy and Safety of Jiuxin Pill in the Treatment of Patients with Stable Angina Pectoris: A Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial.

International journal of general medicine·October 2024·Tongzuo Liu, Jingyi Zhang, Zhiqiang Zhao et al.
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Key Finding

A rigorous multicenter RCT is underway to evaluate whether Jiuxin Pill, a Chinese patent herbal medicine, safely improves exercise tolerance and quality of life in stable angina patients when added to standard Western medical therapy.

What This Means For You

If you or someone you love lives with stable angina pectoris — the chest tightness and squeezing pain that comes on during exercise or stress — you know how much it can limit daily life. Many people with this condition don't get enough relief from standard medications or procedures alone, which is why researchers are looking at traditional Chinese medicine for additional support.

A clinical trial registered in China is investigating a Chinese herbal medicine called Jiuxin Pill, which has long been used in traditional Chinese medicine (TCM) to ease the symptoms of stable angina. The study is carefully designed as a randomized, double-blind, placebo-controlled trial — considered the gold standard in medical research — involving 170 patients across 11 hospitals throughout China.

Participants either received Jiuxin Pill or a placebo (a look-alike pill with no active ingredients) twice daily for about four weeks, while continuing their usual heart medications. Researchers measured how long patients could exercise on a treadmill, how they scored on a quality-of-life questionnaire called the Seattle Angina Questionnaire, how often angina attacks occurred each week, and how much nitroglycerin (an emergency chest pain medication) they needed. Heart rate recovery, physical exertion levels, and any serious heart-related events were also tracked.

This trial is still underway, and its results are expected to provide solid scientific evidence about whether Jiuxin Pill is both safe and effective for people managing stable angina alongside conventional Western medicine.

For patients interested in how TCM and herbal medicine might complement their heart care, this kind of rigorous research is an encouraging step forward. Always speak with a licensed and qualified TCM practitioner or integrative medicine provider before adding any herbal supplement to your treatment plan.

Clinical Notes for Practitioners

This multicenter, randomized, double-blind, placebo-controlled trial (ChiCTR2200060780) is evaluating the efficacy and safety of Jiuxin Pill — a Chinese patent medicine — as an adjunct to conventional pharmacotherapy in 170 patients with stable angina pectoris (SAP), recruited across 11 centers in China. Participants receive Jiuxin Pill (2 pills, bid) or matched placebo over a 28 ± 2-day treatment period, preceded by a 7-day run-in and followed by a 28 ± 2-day follow-up. Primary endpoints include total exercise duration (TED) on treadmill testing and Seattle Angina Questionnaire (SAQ) scores. Secondary endpoints encompass HRR1, METs, maximum ST-segment depression, Borg exertion scale, weekly angina frequency, nitroglycerin consumption, TCM four-diagnostic scoring, and MACE incidence. This protocol addresses a significant evidence gap for Chinese patent medicines in cardiovascular care. Results are anticipated to provide high-quality RCT data to guide integrative clinical decision-making for SAP management.

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