A traditional Chinese medicine composition for treating palpitation due to deficiency of heart and spleen combined with blood stasis and application thereof

Abstract

This invention relates to a traditional Chinese medicine composition for treating palpitations of the heart and spleen deficiency with blood stasis type. The composition is made from the following raw materials in parts by weight: Ganoderma lucidum 7-11 parts, Sedum aizoon 13-17 parts, Sophora flavescens 4-8 parts, Ginkgo biloba 4-8 parts, Triticum aestivum 28-32 parts, Rehmannia glutinosa 10-14 parts, Coptis chinensis 4-8 parts, Cinnamomum cassia 1-5 parts, Lysimachia christinae 13-17 parts, and Rhodiola rosea 13-17 parts. This invention also provides the application of the traditional Chinese medicine composition. The efficacy evaluation of ventricular premature contractions (LOWN grade) before and after treatment in two groups of this invention: The results showed that after treatment, the effective rate of the treatment group (80%) was significantly higher than that of the control group (51.43%) (P<0.05). The comparison of the efficacy of TCM syndromes before and after treatment in two groups of subjects showed that the total effective rate of TCM syndromes in the treatment group was significantly different from that in the control group (p<0.05) using the rank-sum test.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating palpitations of the type with deficiency of both heart and spleen and blood stasis, and its application. Background Technology

[0002] Palpitation is often associated with a weak constitution, emotional distress, overwork, sweating, and exposure to pathogens. A weak constitution, weak heart qi, prolonged illness leading to insufficient heart blood, excessive worry, or overwork damaging the heart and spleen can all cause palpitations due to loss of mental control. Alternatively, kidney yin deficiency can lead to an imbalance of water and fire, causing deficient fire to rise and disturb the mind, resulting in palpitations. Furthermore, spleen and kidney yang deficiency can prevent the transformation and vaporization of fluids, causing them to stagnate and ascend to the heart, suppressing heart yang and obstructing the heart vessels, thus causing this condition.

[0003] Chinese patent document CN104922444A discloses a traditional Chinese medicine for palpitations due to insufficient heart yang, made from the following medicinal materials in the indicated weight ratios: 9 parts black cumin, 2 parts cinnamon twig, 10 parts ophiopogon japonicus, 3 parts valerian, 10 parts poria cocos, 5 parts giant clam shell, 6 parts *Celastrus orbiculatus* fruit, 9 parts *Bryophyllum oxypetalum*, 10 parts *Albizia julibrissin* bark, 3 parts polygala tenuifolia, 2 parts jujube, 10 parts *Ganoderma lucidum*, 9 parts *Phyllostachys edulis* root, and 9 parts *Caragana korshinskii* root. This invention is effective in treating palpitations due to insufficient heart yang. Over many years, use on numerous patients has shown an effectiveness rate of 94.2%.

[0004] Chinese patent document CN104922329A discloses a traditional Chinese medicine for palpitations caused by blood stasis, made from the following herbs in the indicated weight ratios: 15 parts of Achyranthes bidentata, 3 parts of Stellera pilosa, 9 parts of Aristolochia debilis, 3 parts of Lysimachia christinae, 6 parts of Lysimachia christinae, 5 parts of Smilax china, 6 parts of Salvia miltiorrhiza, 5 parts of Lysimachia christinae, 15 parts of Eupatorium fortunei, 9 parts of Eupatorium fortunei, 10 parts of Lysimachia christinae, 9 parts of Aristolochia debilis, 15 parts of Quercus acutissima, 3 parts of Cyperus rotundus, and 15 parts of Cortex Cressidae. This invention is effective in treating palpitations caused by blood stasis. Over many years, studies on numerous patients have shown an effectiveness rate of 91.4%.

[0005] There are many traditional Chinese medicine compositions for treating palpitations, but they all have some drawbacks, such as too many ingredients, difficulty in sourcing materials, high prices, and unclear efficacy and poor treatment results. Therefore, there is an urgent need for a traditional Chinese medicine composition that is effective in treating palpitations caused by deficiency of both heart and spleen with blood stasis, has fewer ingredients, is practical, has high compliance, and is safe and effective. Summary of the Invention

[0006] The purpose of this invention is to address the shortcomings of existing technologies by providing a traditional Chinese medicine composition for treating palpitations of the type with deficiency of both heart and spleen and blood stasis, and its application.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating palpitations of the type with deficiency of both heart and spleen and blood stasis, the traditional Chinese medicine composition being made from the following raw materials in parts by weight: 7-11 parts of Ganoderma lucidum, 13-17 parts of Sedum aizoon, 4-8 parts of Sophora flavescens, 4-8 parts of Ginkgo biloba, 28-32 parts of Triticum aestivum, 10-14 parts of Rehmannia glutinosa, 4-8 parts of Coptis chinensis, 1-5 parts of Cinnamomum cassia, 13-17 parts of Eupatorium fortunei, and 13-17 parts of Rhodiola rosea.

[0008] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 8-10 parts of Ganoderma lucidum, 14-16 parts of Sedum aizoon, 5-7 parts of Sophora flavescens, 5-7 parts of Ginkgo biloba, 29-31 parts of Triticum aestivum, 11-13 parts of Rehmannia glutinosa, 5-7 parts of Coptis chinensis, 2-4 parts of Cinnamomum cassia, 14-16 parts of Eupatorium fortunei, and 14-16 parts of Rhodiola rosea.

[0009] As another preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 9 parts of Ganoderma lucidum, 15 parts of Sedum aizoon, 6 parts of Sophora flavescens, 6 parts of Ginkgo biloba, 30 parts of Triticum aestivum, 12 parts of Rehmannia glutinosa, 6 parts of Coptis chinensis, 3 parts of Cinnamomum cassia, 15 parts of Eupatorium fortunei, and 15 parts of Rhodiola rosea.

[0010] As another preferred example, the medicine composition is in the form of tablets, capsules, granules, oral liquids, or syrups.

[0011] Secondly, this invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for treating palpitations of the type with deficiency of both heart and spleen and blood stasis.

[0012] The advantages of this invention are as follows: Ganoderma lucidum, Rhodiola rosea, and Panax notoginseng are used in clinical practice for heart-related diseases. These three herbs work together to: 1) support the body's vital energy; 2) clear the meridians and dispel pathogenic factors, disperse blood stasis and promote the generation of new blood, ensuring a clear and flowing source, without hindering or depleting the flow, minimizing adverse effects, and combining tonification with unblocking, thus harmonizing the blood vessels, preserving vital energy, and restoring mental well-being, restoring pulse and calming palpitations. Coptis chinensis and Cinnamomum cassia are combined, drawing on the principle of harmonizing Yin and Yang in the Jiaotai Pill, replacing Cinnamomum cassia with Cinnamomum cassia. The heart resides in the Yang position; Cinnamomum cassia is thin and moves upwards without stagnating, warming and promoting upward movement, with a strong effect in clearing the meridians and removing blood stasis; Cinnamomum cassia is deep and heavy, stabilizing without moving, warming and tonifying downwards, effectively benefiting fire, assisting Yang, and warming the internal organs. Gynostemma pentaphyllum, bitter and neutral in nature, tonifies Qi, supports the body's vital energy, and replenishes deficiency without causing stagnation. Yang deficiency easily leads to phlegm and dampness, which stagnate in the blood vessels, hindering the flow of blood and causing stagnation, exacerbating Yin deficiency, leading to insufficient Yin fluids, stagnation of blood, and obstruction of the blood vessels. "For those with insufficient essence, replenish with flavor," the treatment should focus on replenishing yin and nourishing blood vessels, combining tonification with unblocking. Rehmannia root is added for its sweet and cold properties to generate fluids, Sophora flavescens for its bitter and cold properties to dry dampness, and Ginkgo biloba to resolve phlegm. Wheat is added for its gentle and calming effects, its sweet, neutral, and cooling properties to nourish the heart and spleen, relieve irritability and calm the mind; the medicine appears plain, yet it achieves remarkable results. Rehmannia root is clearing and nourishing, cooling without being cold, nourishing yin and blood, replenishing blood vessels and nourishing the heart, clearing the heart and nourishing yin, and also nourishing kidney yin, replenishing kidney water to control heart fire. This invention compares the efficacy of premature ventricular contractions (PVCs) before and after treatment in two groups of subjects, using the rank-sum test to compare the efficacy of PVCs and supraventricular PVCs before and after treatment in both groups; the results show that the total effective rate of PVCs and supraventricular PVCs before and after treatment in the treatment group was statistically significant compared with the control group (P<0.05). The efficacy evaluation of LOWN grading for premature ventricular contractions before and after treatment in two groups of subjects according to this invention: The results showed that, after treatment, the effective rate of the treatment group (80%) was significantly higher than that of the control group (51.43%) (P<0.05). The comparison of the efficacy of TCM syndromes before and after treatment in two groups of subjects according to this invention showed that, using the rank-sum test, the total effective rate of TCM syndromes in the treatment group was significantly different from that in the control group (p<0.05). Detailed Implementation

[0013] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0014] Example 1: A Traditional Chinese Medicine Composition for Treating Palpitation Due to Deficiency of Both Heart and Spleen with Blood Stasis (Part 1)

[0015] 9 parts Ganoderma lucidum, 15 parts Sedum aizoon, 6 parts Sophora flavescens, 6 parts Ginkgo biloba, 30 parts Triticum aestivum, 12 parts Rehmannia glutinosa, 6 parts Coptis chinensis, 3 parts Cinnamomum cassia, 15 parts Tricholoma matsutake, and 15 parts Rhodiola rosea.

[0016] Example 2: A Traditional Chinese Medicine Composition for Treating Palpitation Due to Deficiency of Both Heart and Spleen with Blood Stasis (II)

[0017] 9 parts of Ganoderma lucidum, 13 parts of Sedum aizoon, 8 parts of Sophora flavescens, 5 parts of Ginkgo biloba, 31 parts of Triticum aestivum, 12 parts of Rehmannia glutinosa, 4 parts of Coptis chinensis, 5 parts of Cinnamomum cassia, 14 parts of Eupatorium fortunei, and 16 parts of Rhodiola rosea.

[0018] Example 3: A Traditional Chinese Medicine Composition for Treating Palpitation Due to Deficiency of Both Heart and Spleen with Blood Stasis (Part 3)

[0019] 7 parts Ganoderma lucidum, 17 parts Sedum aizoon, 5 parts Sophora flavescens, 7 parts Ginkgo biloba, 30 parts Triticum aestivum, 10 parts Rehmannia glutinosa, 8 parts Coptis chinensis, 2 parts Cinnamomum cassia, 16 parts Taraxacum mongolicum, and 15 parts Rhodiola rosea.

[0020] Example 4: A Traditional Chinese Medicine Composition for Treating Palpitation Due to Deficiency of Both Heart and Spleen with Blood Stasis (Part Four)

[0021] 11 parts of Ganoderma lucidum, 14 parts of Sedum aizoon, 7 parts of Sophora flavescens, 6 parts of Ginkgo biloba, 28 parts of Triticum aestivum, 14 parts of Rehmannia glutinosa, 5 parts of Coptis chinensis, 4 parts of Cinnamomum cassia, 15 parts of Eupatorium fortunei, and 13 parts of Rhodiola rosea.

[0022] Example 5: A Traditional Chinese Medicine Composition for Treating Palpitation Due to Deficiency of Both Heart and Spleen with Blood Stasis (Part 5)

[0023] 8 parts of Ganoderma lucidum, 16 parts of Sedum aizoon, 6 parts of Sophora flavescens, 4 parts of Ginkgo biloba, 32 parts of Triticum aestivum, 11 parts of Rehmannia glutinosa, 7 parts of Coptis chinensis, 3 parts of Cinnamomum cassia, 13 parts of Tricholoma matsutake, and 17 parts of Rhodiola rosea.

[0024] Example 6: A Traditional Chinese Medicine Composition for Treating Palpitation Due to Deficiency of Both Heart and Spleen with Blood Stasis (VI)

[0025] 10 parts of Ganoderma lucidum, 15 parts of Sedum aizoon, 4 parts of Sophora flavescens, 8 parts of Ginkgo biloba, 29 parts of Triticum aestivum, 13 parts of Rehmannia glutinosa, 6 parts of Coptis chinensis, 1 part of Cinnamomum cassia, 17 parts of Eupatorium fortunei, and 14 parts of Rhodiola rosea.

[0026] Example 7: A Traditional Chinese Medicine Composition for Treating Palpitation Due to Deficiency of Both Heart and Spleen with Blood Stasis (VII)

[0027] 9 parts of Ganoderma lucidum, 17 parts of Sedum aizoon, 5 parts of Sophora flavescens, 7 parts of Ginkgo biloba, 30 parts of Triticum aestivum, 10 parts of Rehmannia glutinosa, 8 parts of Coptis chinensis, 2 parts of Cinnamomum cassia, 16 parts of Eupatorium fortunei, and 15 parts of Rhodiola rosea.

[0028] Example 8: A Traditional Chinese Medicine Composition for Treating Palpitation Due to Deficiency of Both Heart and Spleen with Blood Stasis (Part 8)

[0029] 7 parts Ganoderma lucidum, 14 parts Sedum aizoon, 7 parts Sophora flavescens, 6 parts Ginkgo biloba, 28 parts Triticum aestivum, 14 parts Rehmannia glutinosa, 5 parts Coptis chinensis, 4 parts Cinnamomum cassia, 15 parts Tricholoma matsutake, and 13 parts Rhodiola rosea.

[0030] Example 9: A Traditional Chinese Medicine Composition for Treating Palpitation Due to Deficiency of Both Heart and Spleen with Blood Stasis (IX)

[0031] 11 parts of Ganoderma lucidum, 16 parts of Sedum aizoon, 6 parts of Sophora flavescens, 4 parts of Ginkgo biloba, 31 parts of Triticum aestivum, 11 parts of Rehmannia glutinosa, 7 parts of Coptis chinensis, 3 parts of Cinnamomum cassia, 13 parts of Tricholoma matsutake, and 17 parts of Rhodiola rosea.

[0032] Example 10: A Traditional Chinese Medicine Composition for Treating Palpitation Due to Deficiency of Both Heart and Spleen with Blood Stasis (X)

[0033] 8 parts of Ganoderma lucidum, 15 parts of Sedum aizoon, 4 parts of Sophora flavescens, 8 parts of Ginkgo biloba, 29 parts of Triticum aestivum, 13 parts of Rehmannia glutinosa, 6 parts of Coptis chinensis, 1 part of Cinnamomum cassia, 17 parts of Eupatorium fortunei, and 14 parts of Rhodiola rosea.

[0034] Example 11: A Traditional Chinese Medicine Composition for Treating Palpitation Due to Deficiency of Both Heart and Spleen with Blood Stasis (XI)

[0035] 10 parts of Ganoderma lucidum, 13 parts of Sedum aizoon, 8 parts of Sophora flavescens, 5 parts of Ginkgo biloba, 31 parts of Triticum aestivum, 12 parts of Rehmannia glutinosa, 4 parts of Coptis chinensis, 5 parts of Cinnamomum cassia, 14 parts of Eupatorium fortunei, and 16 parts of Rhodiola rosea.

[0036] Example 12 Clinical Trial

[0037] 1. Clinical Data

[0038] 1.1 Source of Cases

[0039] The cases observed in this study were all patients admitted to the outpatient and inpatient departments of the Emergency Medicine Department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine who met the TCM diagnostic criteria for palpitation of the type of heart and spleen deficiency with blood stasis and the Western medicine diagnostic criteria for ventricular premature contractions.

[0040] 1.2 Diagnostic criteria

[0041] (1) Diagnostic criteria for premature ventricular contractions (PVCs) refer to the 9th edition of Internal Medicine: ① Premature QRS complexes, often exceeding 0.12 seconds in duration, are wide and deformed. ② The direction of the ST segment and T wave is opposite to the direction of the main QRS wave. ③ The pairing interval is constant, and a complete compensatory pause may appear afterward.

[0042] The severity of premature ventricular contractions (PVCs) was determined using the Lown grading system, based on the "Huang Wan Clinical Electrocardiography" (6th edition). Grade 0: No premature ventricular contractions; Grade I: Occasional (<5 times / min or <30 times / h); Grade II: Frequent (≥5 times / min or ≥30 times / h); Grade III: Multifocal premature ventricular contractions; Grade IVa: Recurrent paired premature ventricular contractions; Grade IVb: Short runs of ventricular tachycardia (≥3 premature ventricular contractions); Grade V: Premature ventricular contractions exhibiting the RonT phenomenon.

[0043] (2) Traditional Chinese Medicine (TCM) diagnostic criteria: Referring to the People's Republic of China TCM Industry Standard "Diagnosis and Efficacy Standards for Internal Medicine Diseases" (ZY / T001.1-94), the patient meets the diagnosis of palpitations. The TCM syndrome is diagnosed as deficiency of both heart and spleen, and blood stasis in the heart. The clinical manifestations are: palpitations, insomnia, forgetfulness, pale complexion, dizziness, fatigue, shortness of breath, easy sweating, poor appetite, chest tightness, paroxysmal chest tightness and heart pain, or purplish complexion and lips. The tongue is pale red or dark red, or has ecchymosis, with a thin white coating, and the pulse is thready, or thready and hesitant, or intermittent.

[0044] 1.3 Inclusion Criteria

[0045] ① Meets the Western medicine diagnostic criteria for premature contractions and also exhibits ventricular premature contractions (and meets the LOWN classification); ② Meets the TCM diagnostic criteria for palpitations, with the syndrome differentiation being heart and spleen deficiency with blood stasis; ③ Age ≥ 25 years and < 85 years, gender not limited; ④ Persistent arrhythmia; ⑤ Known components of this preparation with no known allergies; ⑥ During the screening period, laboratory tests for blood and urine routine tests, liver and kidney function showed no significant abnormalities; 90 ≤ Hemoglobin (Hb) ≤ 180 g / L; Negative ≤ Proteinuria (PRO) ≤ 4+; 0 ≤ ALT ≤ 72 U / L; 10 ≤ Creatinine (Cr) ≤ 130 μmol / L; ⑦ Understands and agrees to participate in this study and signs the informed consent form.

[0046] 1.4 Exclusion Criteria

[0047] ① Accompanied by variant angina, poorly controlled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg) or accompanied by hypotension, atrial fibrillation, ventricular fibrillation, chronic arrhythmia (heart rate <45 beats / min), second- or third-degree atrioventricular block, sick sinus syndrome and other serious cardiovascular diseases; ② NYHA functional class III or above; ③ Patients taking the medication during pregnancy or lactation, or patients with schizophrenia; ④ Uncontrollable serious primary diseases of the brain, liver, kidneys, hematopoietic system, etc.

[0048] 1.5 Rejection Criteria

[0049] ① Patients who do not cooperate during treatment; ② Patients who are intolerant to traditional Chinese medicine treatment; ③ Patients who are allergic to the known components of this preparation; ④ Patients nearing the end of their lives, or patients with advanced cardiovascular, cerebrovascular, tumor, or metabolic diseases.

[0050] 2 Research Methods

[0051] 2.1 Grouping Method

[0052] The study employed a double-blind, randomized, controlled clinical trial design. The randomization method involved generating random number tables using Excel and labeling the investigational drugs accordingly. Patients meeting the inclusion criteria were randomly assigned the investigational drug, and then grouped according to the investigational drug label. Patients who participated in the grouping and were blinded were not allowed to participate in other parts of the study.

[0053] 2.2 Treatment methods

[0054] (1) Control group: The control group received routine treatment (appropriate rest, reasonable diet, and corresponding treatment for underlying diseases; appropriate antiarrhythmic drugs were selected according to the condition) plus Jingling Anxin Granules placebo.

[0055] (2) Treatment Group: In addition to the routine treatment, the treatment group received Jingling Anxin Granules (containing Ganoderma lucidum, Sedum aizoon, Rhodiola rosea, Sophora flavescens, Ginkgo biloba, Triticum aestivum, Rehmannia glutinosa, Lysimachia christinae, Coptis chinensis, and Cinnamomum cassia; Example 1). Jingling Anxin Granules were prepared into small-package granules by Jiangsu Jiangyin Tianjiang Pharmaceutical Co., Ltd. A placebo was prepared using 1 / 10 the dose of the test drug to simulate the odor of the test drug. Food additives, such as pigments, flavorings, and bittering agents, were added to make it identical to the test drug in appearance and weight. One packet was taken twice daily (10 AM and 4 PM), diluted with warm water to 200 ml, and taken orally for 4 weeks (28 days).

[0056] 2.3 Treatment Plan

[0057] Seventy subjects were randomly divided into two groups: a control group and a treatment group, with 35 subjects in each group. The control group received routine treatment plus a placebo of Jingling Anxin granules; the treatment group received routine treatment plus Jingling Anxin granules. Treatment lasted for 4 weeks (28 days). The mean heart rate, frequency of premature ventricular contractions (PVCs), Lown classification, and TCM symptom scores were compared between the two groups before and after treatment. The efficacy was evaluated based on changes in PVC frequency, Lown classification, and TCM symptom scores before and after treatment.

[0058] 2.4 Evaluation Methods

[0059] Traditional Chinese Medicine (TCM) Syndrome Therapy Evaluation Criteria: The efficacy evaluation is calculated using the nimodipine method: [(Pre-treatment score - Post-treatment score) ÷ Pre-treatment score] × 100%. ① Marked effect: Significant improvement in relevant clinical symptoms and signs, with a reduction of ≥70% in the total TCM syndrome score; ② Effective: Relevant clinical symptoms and signs alleviated, with a reduction of ≥30% in the total TCM syndrome score; ③ Ineffective: No improvement or even worsening of relevant clinical symptoms and signs, with a reduction of ≤30% in the total TCM syndrome score. Treatment effectiveness rate = (Number of markedly effective + number of effective cases) / Total number of cases × 100%.

[0060] 2.5 Clinical observation indicators

[0061] (1) 24-hour Holter monitoring: average heart rate and frequency of ventricular pre-contractions.

[0062] (2) Comparison of Low-level classifications;

[0063] (3) TCM syndrome score: The "Panic Disease (Ventricular Premature Contraction) Scoring Scale" was formulated based on the "Technical Guidelines for Clinical Research of Syndrome-based New Chinese Medicines" (No. 109 of 2018) issued by the National Medical Products Administration. The scale includes symptoms such as palpitations, chest tightness, dizziness, fatigue, pale lips and nails, and easy startling and forgetfulness. The scoring method is used to score the symptoms.

[0064] 2.6 Observation time and follow-up methods

[0065] Take one packet twice a day (10 AM and 4 PM), mix with warm water to 200 ml, and take orally. The course of treatment is 4 weeks (28 days).

[0066] 3. Statistical Methods

[0067] This study used SPSS 26.0 software for statistical analysis of the data. Quantitative data that conformed to a normal distribution and homogeneity of variance were expressed as (x̄ ± s) and analyzed using t-tests or ANOVA. Data that did not conform to a normal distribution and homogeneity of variance were analyzed using nonparametric rank-sum tests. Quantitative data were expressed as medians (P25, P75) and analyzed using nonparametric Wilcoxon rank-sum tests. Categorical data were compared using chi-square tests; a p-value < 0.05 was considered statistically significant.

[0068] 4. Research Results

[0069] 4.1 General Case

[0070] This study included 70 clinical cases that met the criteria. There were no statistically significant differences in baseline data between the two groups (see Table 1).

[0071] Table 1 Comparison of baseline data between the two groups of subjects

[0072]

[0073] 4.2 Comparison of mean heart rate and premature ventricular contraction frequency before and after treatment in the two groups is shown in Table 2.

[0074] This study included 70 clinical cases that met the criteria. There were no statistically significant differences in baseline data between the two groups (see Table 1).

[0075] Table 2 Comparison of mean heart rate and premature ventricular contraction frequency before and after treatment in the two groups.

[0076]

[0077] Note: Compared with the pre-treatment level in this group. * p < 0.05; compared with the control group, # p < 0.05

[0078] 4.3 Comparison of Lown grading and TCM symptom scores before and after treatment in the two groups of subjects is shown in Tables 3-4.

[0079] The results showed that the Lown grade of premature ventricular contractions in the treatment group and the control group was significantly different from that before treatment (P < 0.05); the difference between the groups after treatment was also statistically significant (P < 0.05). See Table 3 for details.

[0080] Table 3 Comparison of Lown grading before and after treatment in the two groups

[0081]

[0082]

[0083] Note: Compared with the pre-treatment level in this group. * p < 0.05; compared with the control group, # p < 0.05

[0084] The TCM symptom scores of the treatment group and the control group were significantly different before treatment compared with those before treatment (P < 0.05); and the TCM symptom scores of the treatment group and the control group were significantly different after treatment (P < 0.05). Regarding palpitations, chest tightness, shortness of breath, dizziness, fatigue, and insomnia, the treatment group showed significantly different scores compared with the control group after treatment (P < 0.05). Regarding pale complexion and numbness in the hands and feet, there was no significant difference between the treatment group and the control group after treatment (P > 0.05). See Table 4 for details.

[0085] Table 4 Comparison of TCM syndrome scores before and after treatment in the treatment group and the control group ( point)

[0086]

[0087] Note: Compared with the pre-treatment level in this group. * P < 0.05; compared with the control group, # P < 0.05

[0088] 4.4 Comparison of treatment efficacy between the two groups of subjects before and after treatment is shown in Table 5.

[0089] The results showed that there were statistically significant differences in the total effective rate of ventricular treatment, Lown grade, and TCM symptom efficacy between the treatment group and the control group (P < 0.05).

[0090] Table 5 Comparison of treatment efficacy between the two groups for premature ventricular contractions after treatment.

[0091]

[0092]

[0093] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and additions without departing from the method of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating palpitations due to deficiency of both heart and spleen with blood stasis, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Ganoderma lucidum 7-11 parts, Sedum aizoon 13-17 parts, Sophora flavescens 4-8 parts, Ginkgo biloba 4-8 parts, Triticum aestivum 28-32 parts, Rehmannia glutinosa 10-14 parts, Coptis chinensis 4-8 parts, Cinnamomum cassia 1-5 parts, Evodia rutaecarpa 13-17 parts, and Rhodiola rosea 13-17 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 8-10 parts of Ganoderma lucidum, 14-16 parts of Sedum aizoon, 5-7 parts of Sophora flavescens, 5-7 parts of Ginkgo biloba, 29-31 parts of Triticum aestivum, 11-13 parts of Rehmannia glutinosa, 5-7 parts of Coptis chinensis, 2-4 parts of Cinnamomum cassia, 14-16 parts of Eupatorium fortunei, and 14-16 parts of Rhodiola rosea.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 9 parts Ganoderma lucidum, 15 parts Sedum aizoon, 6 parts Sophora flavescens, 6 parts Ginkgo biloba, 30 parts Triticum aestivum, 12 parts Rehmannia glutinosa, 6 parts Coptis chinensis, 3 parts Cinnamomum cassia, 15 parts Eupatorium fortunei, and 15 parts Rhodiola rosea.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition is in the form of tablets, capsules, granules, oral liquids, or syrups.

5. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a drug for treating palpitations of the type with deficiency of both heart and spleen and blood stasis.

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