Clinical Literature Research of Elipulse
Elipulse is a oral capsule made by extracting effective ingredients from red ginseng, cassia twig and ligusticum wallichii. It is a healthy food which supports to treat the coronary heart disease, angina, coronary heart failure. This paper reviews clinical literature research, clinical research, quality analysis, toxicology research, safety research, botanical composition mechanism of action etc. which provides the basis for the efficacy and safety of Elipulse.
To keep in mind, the literature suggests that Elipulse has curative effects however Elipulse will be marketed as a natural health product, herbal supplement, and therefore is subjugated to the marketing laws that pertain to its product type. Elipulse will only be marketed within the boundries of the law and use words like help, assist, with no mention of schedule A diseases in mainstream media marketing. Elixir Canada Medicine Company Ltd also understands that no where in the marketing of the product Elipulse will it use the literature to persuade or affect customers in avoiding conventional medicine. Elipulse is not a replacement for medicine or surgery or procedures, it is a supplement in order to improve health with a specified function.
- Richard Wang, Director of Marketing and Public Relations Elixir Canada Medicine Company Ltd.
Collection of Clinical Trials for Elipulse Formulae,
Summary:
Many papers about Elipulse have been published in core journals and magazines, these include 113 Cases of the Treatment for Coronary Heart Disease Unstable Angina Pectoris with Elipulse, Clinical Research of the Treatment for End-Stage Renal Disease with Heart Failure with Elipulse, Observation on Clinical Efficacy of Elipulse in the Adjuvant Treatment of Severe Congestive Heart Failure, Clinical Research of the Elipulse in the Treatment of Chronic Congestive Heart Failure, Influence of Elipulse on the Curative Effect and Living Quality of Chronic Stable Angina Patients, Observation on Clinical Efficacy of Pharmaceuticals in the Treatment of 160 Cases Chronic Cardiac Failure, Clinical Research of Elipulse in the Treatment of Early Diabetic Nephropathy, Observation on Clinical Efficacy of Elipulse in the Treatment of Hypertension etc.
Clinical 1.
In the thesis of 113 Cases of the Treatment for Coronary Heart Disease Unstable Angina Pectoris with Elipulse，clinical effect of Elipulse on coronary heart disease unstable angina pectoris is observed. 113 cases of patients with coronary heart disease unstable angina pectoris shall be divided into two groups using the method of single-blind randomized control.
Conventional therapies including oxygen inhalation, dilatation of coronary artery and anticoagulant medicines shall be given to the control group. In addition to the conventional therapy, the therapeutic group will add oral Elipulse with each time three grains, three times a day, and treatment courses of these two groups are all 30 days.
Observe the improvement extent of the angina pectoris, electrocardiogram curative efficacy and hemorheological parameters, etc. of these two groups.
Results: The curative efficacy on the severity of illness index of angina pectoris of these two groups is improved, of which the total effective rate for treatment group is 97.14%, superior to that of the control group 81.40% (P<0.01); the electrocardiogram curative efficacy and hemorheological parameters of the two groups are all improved (P<0.05) after treatment, but the comparison between these two groups after treatment has no statistical significance.
Conclusions: Adjuvant therapy of Elipulse can significantly improve the severity classification of patients’ angina pectoris and also improve electrocardiogram and hemorheology to a certain extent. At the same time，Elipulse has positive clinical curative efficacy on treating unstable angina pectoris when using conventional dilatation of coronary artery and anticoagulant medicines. The effect is positive and treating with Elipulse is simple, safe without toxic side effect.
Clinical 2.
In the thesis of Clinical Observation of Elipulse in the Treatment of End-stage Renal Disease with Heart Failure, the clinical efficacy of Elipulse in the treatment of end-stage renal disease with heart failure is investigated.
Methods: 40 patients using the method of single-blind are randomly divided into the treatment group and control group with 20 cases in each group. The control group is given conventional therapy and the treatment group is given Elipulse in addition to conventional therapy,each time 0.9 g, 3 times a day, orally.
Results: The effective rate is 55% in the control group and 85% in the treatment group. Compared with the effective rates of these two groups, the difference is statistically significant (P<0.05). The ultrasonic cardiogram index after the treatment is improved compared with that before the treatment in both groups, the difference is statistically significant (P<0.05). The ultrasonic cardiogram index in the treatment group is better than that in the control group after the treatment, the difference is statistically significant (P<0.05).
Conclusion: Elipulse in supportive treatment with conventional medicine of end-stage renal disease with heart failure has better clinical efficacy.
Clinical 3.
In the thesis of observations on clinical efficacy for adjunctive therapy on severe congestive cardiac failure by using Elipulse, To observe clinical efficacy and safety for adjunctive therapy on severe congestive cardiac failure by using Elipulse.
Method: 68 patients with severe congestive cardiac failure were randomly divided into two groups: 34 patients in the control group were subjected to conventional treatments (rest, oxygen inhalation, cardiac reinforcement, diuresis, blood vessel dilatation, symptomatic treatment and others); 34 patients in the observation group were administered with Elipulse on the basis of conventional treatments, 0.9 g once, three times a day.
Four weeks were considered as one treatment course for both groups. Changes in heart rates, blood pressure, electrocardiogram, color ultrasound analysis on heart, atrial natriuretic polypeptide (ANF), electrolytes and creatinine before and after administration in the patients in the two groups were monitored.
Results: Elipulse can improve cardiac functions and reduce plasma ANF level, and the differences were significant in comparison to those in the control group (P<0.01).
Conclusion: the therapeutic efficacy for treating severe congestive cardiac failure by using Elipulse was satisfactory, it had no obvious toxic and adverse effects.
Clinical 4.
In the thesis of A Clinical Study on Elipulse in the Treatment of Chronic Congestive Cardiac Failure，the effects of Elipulse on patients with chronic congestive cardiac failure and neuroendocrine system is investigated.
Method: patients with congestive cardiac failure are randomized into two groups after standard treatments on anti-cardiac failure to stabilization (grade II~III cardiac functions) with 98 cases in the control group and 122 cases in the treatment group. The patients in the control group are subjected to conventional treatments with reference to the guidance on diagnosis and treatments on chronic cardiac failure in adults in USA（revised version in 2005）, while the patients in the treatment group are administered with Elipulse on this basis.
Four weeks are considered as a treatment course, grades of cardiac functions, and changes in neuroendocrine hormone level, living quality and other parameters for therapeutic efficacy as well as safety parameters are observed after one treatment course.
Results: the grades of cardiac functions in the patients with cardiac failure in the treatment group after treatments are significantly improved, the effective rate is 85.2%; in contrast, the effective rate in the control group is 75.5%, and the difference between the two groups is statistically significant (P<0.05). In comparison to the control group, the highly sensitive C-reactive protein (hs-CRP) level decreases, and the difference in the interclass comparison is statistically significant (P<0.05), and the differences in the comparisons in other parameters are not statistically significant (P>0.05).
Conclusion: Elipulse has significant therapeutic efficacy in treating chronic cardiac failure. The present study shows that the cardiac functions of the patients with cardiac failure in the treatment group in comparison to those in the control group are significantly improved, and the total effective rate is as high as 85%. Among which the improvement in excellence rate is more evident, indicating that the efficacy in improving cardiac functions is better in the patients with poor cardiac functions. Furthermore, the comparisons in the changes in ET, NT-proBNP, hs-CRP and ANP in the patients from the two groups before and after treatments show that ET, NT-proBNP, hs-CRP and ANP in the patients from the treatment group and the control group with the same cardiac functions are almost identical before treatments, and the parameters in the two groups significantly decreases in comparison to those before treatments, and the differences are statistically significant (P<0.05); when the grades for cardiac functions were different, ET, NT-proBNP, hs-CRP and ANP in the patients from the treatment group and the control group after treatments significantly decreases in comparison to those before treatments, and the differences are statistically significant (P<0.05). In the interclass comparison, the differences before and after the treatments are all statistically significant (P<0.05). The improvements of Elipulse on cardiac functions may be related to the inhibition on excessive activation of neuroendocrine factors. Moreover, patients with chronic cardiac failure are mostly senile people, their hepatic and renal functions may go down to some extents, several kinds of drugs should be simultaneously administered for combined therapy, and drug interaction may further lead to risks in impairing the functions of liver, kidney and other organs. No adverse effect is detected during the utilization of Elipulse in the present study, indicating that it is safe for application.
The accomplishment of the present study made up the inadequacy in clinical studies on Elipulse and provided clinical evidence for the investigations on chronic congestive cardiac failure and neuroendocrine system.
Clinical 5.
In the thesis of Effects of Elipulse on Therapeutic Outcome and Quality of Life for Coronary Artery Disease Patients with Stable Angina Pectoris, clinical curative effects and the improvement of the living quality of patients with stable angina pectoris after taking Elipulse are investigated.
A total of 132 CHD subjects with SAP diagnosed by coronary artery angiography(CAG) are divided into two groups, patients to undergo percutaneous coronary intervent (PCI) are divided into treatment group. Patients were given Elipulse in the research group (n=67) and Isosorbide Dinitrate in the control group (n=65) for 6 months. To compare the treatment and living quality of the two groups.
Results: improvement of angina and electrocardiogram and quality of life in the research group are much better than those in the control group (P < 0 .05). Conclusions: Elipulse can significantly improve angina and the quality of life in CHD patients with SAP. According to findings of Li Zongduo et al[1]., Elipulse is beneficial to expand coronary artery, increase coronary blood flow, lower blood pressure, increase cardiac output, resist pituitrin-induced myocardial ischemia, improve hypoxia tolerance, reduce the CK value of serum, protect myocardial cells and increase myocardial nutritional blood flow. Du Jiuzhou et al discovered [2] that Elipulse could enhance recovery of myocardium mitochondria, and reduce degree of injury to myocardial cell by pituitrin. This study shows that advantages of Elipulse, when used to treat SAP, lie not only in its superiority over isosorbide dinitrate group regarding controlling frequency of angina pectoris attacks, increasing exercise tolerance, and shortening attack time, but also in better outcome in improving living quality of patients.
Clinical 6.
In the thesis of Clinical Efficacy of Drug Treatment for Chronic Heart Failure: Analysis of 160 Cases, [Abstract]
Objective: To analyze retrospectively the efficacy of Elipulse for chronic heart failure.
Methods: The patients with chronic heart failure were assigned to receive either routine anti-heart failure therapy alone (n=60, control group) or routine therapy plus Elipulse (3 capsles/time, three times/day orally) (n=100, experimental group) for 2 months. The ejection fraction (EF) and brain natriuretic peptide (BNP) level were recorded during treatment.
Results: The improvement in EF and BNP for the experimental group was significantly better than in the control group (P < 0 .05).
Conclusions: Addition of Elipulse to routine therapy resulted in better efficacy for chronic heart failure.