Comparison of Buyang Huanwu Granules and Naoxintong Capsules in Treatment of Stable Angina Pectoris: Rationale and Design of a Randomized, Double-blind, Multicenter Clinical Trial

doi:10.21203/rs.3.rs-451005/v1

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Study protocol

Comparison of Buyang Huanwu Granules and Naoxintong Capsules in Treatment of Stable Angina Pectoris: Rationale and Design of a Randomized, Double-blind, Multicenter Clinical Trial

https://doi.org/10.21203/rs.3.rs-451005/v1

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Background: Stable angina pectoris (SAP) is seriously threatened the health of human life currently, and the mortality is in a continuous rising stage. The current treatment strategies mainly include pharmaceutical therapy and revascularization. In China, Buyang Huanwu granules (BYHW) and Naoxintong capsule (NXT) have been used in the treatment of SAP, but it is not clear which one is better in terms of relieving symptoms and improving quality of life. Therefore, we design a clinical trial to compare the efficacy and safety between NXT and BYHW in the treatment of SAP.

Methods: This is a randomized, double-blinded, parallel controlled, multicenter clinical trial protocol. On the basis of western medicine standardized treatment, a total of 128 SAP patients will be randomly divided into intervention group 1 (NXT group), intervention group 2 (BYHW group) and control group (placebo group) at a 2:1:1 ratio. A 2-week run-in period is required prior to randomization, and 1-week baseline period and 4-week treatment period are included in this study. The primary outcome is the efficacy rate of stable angina symptom score improvement; the secondary outcomes include the effect of electrocardiogram, Seattle Angina Questionnaire scores, and the nitroglycerin consumption.

Discussion: This study will evaluate the efficacy and safety between NXT and BYHW in the treatment of SAP. The results will provide critical evidence of the Chinese herbal medicine for SAP.

Trial registration: Chinese Clinical Trials Registry ChiCTR1800015191. Registered on 13 March 2018. http://www.chictr.org.cn/showproj.aspx?proj=25818

Internal Medicine

Translational Medicine

Integrative & Complementary Medicine

Stable angina pectoris

Traditional Chinese medicine

Buyang Huanwu granules

Naoxintong capsules

randomized controlled trial

Table 1. Characteristics of the Investigational Product

Study drug 1: Naoxintong Capsule

♦ Ingredients: Astragalus mongholicus Bunge [Fabaceae; Radix Astragali], Hirudo nipponia Whitman [Hirudinidae; Whitmania pigra Whitman], Boswellia carteri Birdw., [Burseraceae; Boswellia carterii], Commiphora myrrha (T.Nees) Engl., [Burseraceae; Myrrha], Salvia miltiorrhiza Bunge [Lamiaceae; Salviae Miltiorrhizae Radix Et Rhizoma], Achyranthes bidentata Blume [Amaranthaceae; Achyranthes], Neolitsea cassia (L.) Kosterm. [Lauraceae; Cassia Twig], Morus alba L. [Moraceae; Mulberry Twig], Spatholobus suberectus Dunn [Fabaceae; Caulis Spatholobi], Buthus martensii Karsch [Buthidae; Scorpion];

♦ Property: capsule; the contents are brown to black brown powder; bitter in taste;

♦ Specification: 0.4g/ capsule;

♦ Bach number: 200593.

Placebo 1: Capsule placebo

♦ Ingredients: corn starch, silica, caramel (liquid), 2% NXT powder and sunset yellow;

♦ With identical color, specification, packaging, property of contents and other features with Naoxintong Capsule;

♦ Bach number: 200501.

Study drug 2: Buyang Huanwu Granule

♦ Ingredients: Astragalus mongholicus Bunge [Fabaceae; Radix Astragali], Angelica sinensis (Oliv.) Diels [Apiaceae; Angelicae Sinensis Radix], Paeonia lactiflora Pall. [Paeoniaceae; Paeoniae Radix Rubra], Lumbricus rubellus (Oligochaeta, Lumbricidae), Ligusticum chuanxiong Hort. [Apiaceae; Chuan xiong Rhizoma], Carthamus tinctorius L. [Asteraceae; Carthami Flos], Prunus persica (L.) Batsch [Rosaceae; Semen Persicae].

♦ Property: granule; the contents are brown to black brown granules; bitter in taste;

♦ Specification: 5.5g/ bag;

♦ Bach number: 200603.

Placebo 2: Granule placebo

♦ Ingredients: dextrin, 1% Ligusticum chuanxiong, bitterness SA, stevioside, lemon yellow, and chocolate brown;

♦ With identical color, specification, packaging, property of contents and other features with Buyang Huanwu granule;

♦ Bach number: 200601.

Table 2 Measurement items and time points for data collection.

Item	Run-in period (-14±1) day	Baseline period (-7~0) days	Intervention period (28 ± 4) days
Basic information
Informed consent	×
Inclusion/exclusion criteria		×
Demographic data	×
Randomization		×
Record medical history and allergy history	×
Record complication and symptom	×
Record concomitant medication	×
Access to the "Doctor Tao" platform	×
Urine pregnancy test	×
Safety assessment
Vital signs and physical examination	×	×	×
Blood and urine routine examination		×	×
Liver function (ALT, AST, AP, TBIL, γ-GT)		×	×
Kidney function (SCr, BUN)		×	×
Coagulation function (PT, APTT, TT, FIB, INR)		×	×
Fasting blood glucose		×	×
Efficacy indicators
Stable angina symptom score		×	×
Electrocardiogram		×	×
Seattle Angina Questionnaire		×	×
Nitroglycerin consumption	×	×	×
Other works
Drug distribution	×	×
Drug recycling		×	×
Record adverse events and combined medication		×	×
Compliance judgment		×	×

Note: ALT=alanine aminotransferase, AST=aspartate aminotransferase, AP=alkaline phosphatase, TBIL=total bilirubin, γ-GT=γ-glutamyl transpeptidase, SCr=serumcreatinine, BUN=blood urea nitrogen, PT=prothrombin time, APTT=actived partial thrombolastin time, TT=thrombin time, FIB=fibrinogen, INR=international normalized ratio.

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Review #1 received at journal
04 Oct, 2021
Editorial decision: Major revision
04 Oct, 2021
Reviews received at journal
24 Sep, 2021
Reviewer #1 agreed at journal
23 Sep, 2021
Reviewers invited by journal
23 Sep, 2021
Editor assigned by journal
05 May, 2021
Submission checks completed at journal
05 May, 2021
First submitted to journal
21 Apr, 2021

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Comparison of Buyang Huanwu Granules and Naoxintong Capsules in Treatment of Stable Angina Pectoris: Rationale and Design of a Randomized, Double-blind, Multicenter Clinical Trial

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