Bonnie S. Friehling, M.D. - Nutritional Balancing       Ozone Therapy         Meso-Esthetics
Ozone Therapy Study

This is a research program sponsored by The American Academy of Ozonotherapy entitled, “Safety and Efficacy of Ozone Therapy.”
 
The intent of this study is:
1. To validate the safety of ozonotherapy in regards to any serious complications or side effects.
2. To evaluate the incidence of minor side effects from the various modalities used in ozone therapy.
3. To evaluate the efficacy of the various modalities used in ozone therapy.
4. To evaluate the cost of ozone therapy for each condition being treated.
5. To demonstrate whether or not the various modalities used in ozone therapy are more or less safe, cost effective, and clinically effective than conventional approved treatments.

Need For The Study
Ozone therapy is often effective in conditions such as pain, weakness, immune dysfunction, chronic and acute infections, frailties of aging, and auto-immune diseases in which other therapies including conventional therapies are not effective. Ozone therapy has the additional benefit of being free of any serious side effects or complications. Many patients suffer from medical conditions that may respond readily to ozone therapy, but are not offered this therapy because of a concern about efficacy and side effects.

Another consideration is expense and safety. And a third concern is that even though various international studies already published have shown that ozone therapy can often be used in place of other therapies that are much more expensive and dangerous such as surgery or pharmaceutical therapy none of these studies have been conducted in the United States. Because of this lack of American studies ozone therapy currently has no approved use in the United States. This lack of research is limiting the availability of ozone therapy to many who would potentially benefit from it.

Furthermore, ozone therapy is inexpensive and uses a substance that costs only pennies and cannot be patented. In view of the current cost of medical care crisis that many countries including the United States are facing, showing that an inexpensive treatment can safely and effectively replace more dangerous and more expensive therapies will greatly increase the number of people who can benefit from medical care in general.

This project will research the efficacy, safety, and cost effectiveness of ozone therapy. The major benefit will be to demonstrate that there are many times in which patients can be spared exposure to more dangerous and or more expensive therapies by being treated with ozone therapy.

Subject Population
Subjects will be chosen as they present to the private practices of the principle investigator and the sub-investigators according to their medical needs and concerns.

Qualifications of Co-Investigators
All co-investigators must:
1. Be currently licensed in their state to perform the ozone application(s) that they will be using.
2. Be a current Fellow of the American Academy of Ozonotherapy (AAO). All co-investigators who will be using Prolozone® Therapy must be additionally credentialed by the AAO in Prolozone® Therapy.
3. Must use an ozone generator that meets the published standards of the AAO. Applicant will be asked to submit a photo and description of the generator they are using.
4. Must use acceptable standards of care involving hygiene and diagnosis.

Duties of Co-Investigators
All co-investigators must:
1. Follow the guidelines for ozone therapy as stated in the Madrid Declaration and in the text, The Principles and Applications of Ozonotherapy. The Madrid Declaration can be accessed through the AAO web site www.aaot.us. The Principles and Applications of Ozonotherapy is available at www.amazon.com. Any procedure involving the use of ozone therapy not listed and approved of in the Madrid Declaration and in The Principles and Applications of Ozonotherapy must receive formal prior approval from the principle investigator (PI) before they are utilized.
2. Immediately inform the PI in writing of any change in licensure or clinic status.
3. Immediately inform the PI of any serious complications.
4. Enter the required information in the provided Excell spread sheet and download into the PI’s data base at the completion of each subject’s treatment.
5. Make sure that each subject signs the informed consent for treatment.
6. Pay a yearly administrative fee.
7. Maintain licensure and AAO status as stated under “Qualifications.”
8. Immediately make available all subject records at the request of the PI.

Risks
As with all IV therapies, there is a risk of phlebitis, ecchymosis, and extravasation of materials. When soft tissues or joints are being injected, there is a risk of ecchymosis, pain, local infection, and swelling. When used topically there is a chance of rash. These risks are all minimal and uncommon.
Diagnosis will be performed in the conventional manner as per standard of care. Ozone therapy can be used in a wide variety of clinical situations. It is often used in conditions in which other treatment modalities can be used. Each investigator will determine if it is in the best interest of the subject to undergo a trial of ozone therapy before attempting other modalities. In many cases, the subject will already have tried other therapies. 
Additionally, in some cases ozone therapy will be used in conjunction with other modalities such as antibiotics, physical therapy, chiropractic therapy, homeopathy, and conventional therapy.

Ozone therapy is often effective in conditions in which other therapies including conventional therapies are not effective. Most subjects will be chosen because they have been resistant to all other modes of therapy. Ozone therapy has the additional benefit of being without any serious side effects or complications. Many patients suffer from medical conditions that would respond readily to ozone therapy, but are not offered this therapy because of a concern about efficacy and side effects.

Another consideration is expense and safety. Ozone therapy can often be used in place of other therapies that are much more expensive and dangerous such as surgery or pharmaceutical therapy. The major benefit from this project will be to demonstrate that there are many times in which patients can be spared exposure to more dangerous and or expensive therapies by being treated with ozone therapy.

Confidentiality of Data
All subjects will be recruited from the private practice of the principle investigator and co-investigators. Thus each subject will have a medical record. All information regarding subject treatment and results will be kept in each subject’s medical record. On the front of each medical record will be the identifying code for that subject. The codes will be the subject’s first and last initial followed by the birth date. For example, Frank Shallenberger born on July 10, 1946 will code as FS71046. There will be no identifying data disclosed to any third party other than the principle investigator, co-investigator, and the FDA.

Informed Consent
Before receiving any mode of therapy pursuant to this project, each subject will receive the attached Informed Consent to read and sign. The co-investigator will offer in person to answer any questions or concerns the subject has prior to signing the form. The informed consent will be signed at the co-investigator’s clinic.
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