Since the beginning, Dr. Rath and his research team have placed strong emphasis on clinical research.
As a result, for the first time in medicine we have provided the clinical documentation that a natural supplement program can stop progression and even reverse calcified coronary deposits.
It was our extensive research focus that set an example for many other nutrition-oriented companies to understand the importance of clinical research and clinical studies in documenting the effectiveness of natural health.
Our clinical studies have confirmed the effectiveness and health benefits of specifically designed nutrient synergy programs in various aspects of health. Clinical research is an imperative part of our continuous scientific endeavor and mission to improve human health worldwide by optimizing the use of vitamins, and other natural substances in enhancing cellular metabolism and optimum function of the body.
What Are Clinical Studies? What Are Clinical Studies?
Clinical trials are research studies in which researchers and doctors answer specific questions regarding the health effects of new therapies or new ways of using existing treatments to determine their safety and efficacy. Carefully conducted clinical trials are the fastest and safest ways to find solutions for many health problems. Clinical trials are usually complicated, occur in a few phases, and are very costly.
Clinical trials are monitored by the clinical trial team, which includes doctors, nurses, and other health care professionals. The clinical trial team checks the participant’s health at the beginning and during the trial and remains in touch with the participant after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition and requires cooperation with a research team as well. Clinical trial participants gain access to new research treatments before they are widely available, and they help others by contributing to medical research. Clinical studies conducted with natural substances, such as micronutrients, are not associated with a risk of unwanted side effects like clinical trials involving pharmaceutical drugs. Clinical trial participation is most successful when the specific study protocol is carefully followed and there is frequent contact with the research staff. ...hide content
What is a clinical study protocol? What is a clinical study protocol?
A clinical study protocol is a carefully designed study plan on which a clinical trial is based. It describes what types of patients may participate in a trial, the schedule of tests, procedures, medications and dosages, and the length of the study. A study protocol safeguards the health of the participants as well as answers very specific research questions.
We have conducted several clinical trials and developed several specific clinical trial protocols. Our study protocols received the local and central IRB (Institutional Review Board) commission approval. The IRB is an independent committee of physicians, statisticians, lawyers, community advocates, and other professionals who approve or reject clinical trials conducted with pharmaceutical drugs. IRB commission approval means that the study is conducted according to Good Medical Practice and other medical standards, and ensures that a clinical trial is ethical and the rights of study participants are protected. ...hide content
How are clinical trials conducted? How are clinical trials conducted?
There are several phases of clinical trials that have been developed specifically for testing pharmaceutical drugs. Each trial phase sets up different objectives and vary in duration.
Phase I Trials
The primary objective of a Phase I trial is to define the safety of a new drug or treatment, and identify side effects and proper dosing of a drug. A Phase I trial usually enrolls a small group of patients (20-80).
Phase II Trials
A Phase II trial provides information about benefit, effectiveness and safety of a new drug or treatment. Phase II trials may focus on particular health aspects in certain diseases and are conducted with a larger group of patients (100-300).
Phase III Trials
Phase III trials further test the effectiveness of a new drug or procedure and compare it with the current standard therapy. They typically involve large groups of patients (1,000-3,000) from clinics and medical centers nationwide.
Phase IV Trials
Phase IV trials are conducted after the drug or treatment has been marketed and is available for general use. These trials continue to collect information about the drug/treatment effects in various populations and any side effects associated with long-term use. This trial phase is also called a post marketing surveillance study. ...hide content
What Are Pilot Studies?What Are Pilot Studies?
Pilot studies usually enroll a small number of patients, sometimes as few as a dozen or less, and are conducted for a few weeks to a few months. The primary objective of pilot studies is to identify preliminary effectiveness of a new substance or treatment, define the proper dosing, and recognize side effects and safety ...hide content
What Are Double-Blind Placebo-Controlled Studies?What Are Double-Blind Placebo-Controlled Studies?
A placebo-controlled study is a method of investigating a drug/treatment in which an inactive substance (the placebo) is given to one group of participants, while the substance which is being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition. A placebo is an identical looking pill or powder that has no treatment value (i.e., a “sugar” pill).
Double-blind means that neither the patient nor the physician knows which participants are receiving the experimental treatment and which are getting a placebo. By using this approach, neither the patients' or the doctors' expectations about the experimental drug can influence the outcome. The results are fully objective. Double-blind is considered the golden scientific standard for clinical trials. ...hide content
What is a Randomized Controlled trial?What is a Randomized Controlled trial?
Randomized means assigned by chance. In a randomized controlled trial the patients are indiscriminately assigned to two groups; one receiving the new treatment/drug, and the other receiving the placebo. Neither a patient nor a physician chooses who receives the new treatment or the placebo.
Statistical significance: Statistical analysis is used in clinical trials to gather relevant information about the chance that a specific outcome observed in a selected number of patients (a trial sample) can be repeated when a large number of people (the target population) will follow the same procedure or treatment. These analyses require that the research questions be translated into numerical values that describe these relationships.
In clinical trials, the level of statistical significance is determined by experts in the field and depends on the number of participants studied (the more patients involved the more reliable the result) and the observations made, as well as the magnitude of differences observed.
The probability of the occurrence of the observed effects is reflected by a P value. By convention, P value less than 0.05 is interpreted as being "statistically significant," which means that the result is likely to occur in a large population. ...hide content
Who sponsors clinical trials?Who sponsors clinical trials?
Clinical trials are very costly and are usually sponsored by the pharmaceutical industry, large organizations or even individuals, and such sponsorship often involves bias related to the interpretation of the data or the objectives of the study.
Dr. Rath and his companies stand unique and independent in this area. Dr. Rath’s activities are not-for-profit, and all revenues are channeled to the Dr. Rath Health Foundation, a non-profit organization which sponsors our Research Institute, clinical trials, various research projects conducted in collaboration with other research institutions, and public education efforts. Dr. Rath’s mission is Health for All by 2020 with a goal to eradicate the most detrimental diseases on the planet. ...hide content
Clinical trials with Natural ComponentsClinical trials with Natural Components
Contrary to pharmaceutical drugs, which are chemical molecules that are toxic to the body, vitamins and nutritional supplements are natural components of food and are safe. They belong to a so called GRASS category (Generally Referred As Safe Substances), and therefore the FDA does not require their clinical testing.
However, Dr. Rath’s strong focus on thorough scientific documentation of the value of natural approaches for health has been expanded to clinical research. Over the years we have dedicated our scientific and economic resources to providing clinical documentation of the effectiveness of natural substances in maintaining health, and as a safe alternative approach in various health issues. We have conducted various types of clinical studies, including randomized double-blind placebo-controlled clinical trials with natural compounds acting in synergy in order to document their effectiveness and safety when administered solely or as an adjunct to conventional treatments in various aspects of health. ...hide content
Clinical Trials With Cellular NutrientsClinical Trials With Cellular Nutrients
a) A double-blind placebo-controlled randomized clinical study in 131 patients suffering from irregular heart beat (arrhythmia)
b) Clinical study in:
- high cholesterol (hypercholesterolemia)
- heart failure
- high blood pressure (hypertension)
- bone fractures
More than 100 reputable medical clinics in the United States, Europe, and India have participated in our clinical studies. ...hide content