Patient Trials
Orthonova®
Advanced Formula Patient Trial Results
Orthonova®
Advanced Formula Patient Trial Results
The entire study took 3 months to finish, and included 50 volunteers at 3 locations in the U.S.
The entire study took 3 months to finish, and included 50 volunteers at 3 locations in the U.S.
Patient trials for the nutraceutical dietary supplement OrthoNova® AF (Advanced Formula) took place between January 2020 and March 2020. OrthoNova® AF is a nutraceutical dietary supplement used in adults to address the discomfort of damaged and/or inflamed joints in their backs, necks, arms, hands, legs or feet, caused by osteoarthritis, repetitive motion, overuse, injury and/or joint surgery and recovery.
Novapath Bio, the sponsor, thinks it is important to reveal the results of the trial.
Novapath Bio, the sponsor, thinks it is important to reveal the results of the trial.
Why Was the Trial Needed?
Over 55 million Americans experience some form of joint pain and stiffness, the most common being osteoarthritis. Osteoarthritis affects millions of people worldwide. It occurs when the protective (articular) cartilage that cushions the ends of your bones wears down over time. Although osteoarthritis can affect any joint, the condition most commonly affects joints in your hands, knees, hips and spine. Joint pain and stiffness are also caused by aging, overuse, injury and post-surgical recovery. Irrespective of the cause, joint pain is a serious issue and its treatment requires a safe, non-invasive and natural approach for those desiring non-pharmaceutical and non-surgical options.
Some treatments for joint stiffness and discomfort do not offer relief for everyone, and sometimes treatments stop working over time. Most commercially available supplements are ineffective and, in many studies, were no better than a placebo. Researchers wanted to know how Orthonova® AF affected joint discomfort in a group of patients who were taking other medicine(s) and supplements for joint pain, but still had pain. They also wanted to find out how tolerable OrthoNova® AF was in this group of patients.
All patients in the study were over 18 and had moderate to severe joint pain and/or discomfort at the start of the trial.
All patients in the study were over 18 and had moderate to severe joint pain and/or discomfort at the start of the trial.
What Kind of Study Was This?
This study required that all patients assess their current pain levels prior to use of OrthoNova® AF using a supplied Patient Assessment Form. In this assessment, patients were asked to localize their pain to specific areas of their body and also provide background on injury dates, treatments, surgeries and any current or past medications. This provided a baseline from which results could be measured. Patients were also requested to discontinue use of any and all supplements prior to use of OrthoNova® AF.
All patients took two vegetable capsules per day of OrthoNova® AF for 30 days.
All patients took two vegetable capsules per day of OrthoNova® AF for 30 days.
What Happened During the Study?
During this study, patients stopped any pain medicine they had been taking, and started taking 1360 mg (two capsules) of Orthonova® AF every day. Doctors asked patients to keep a detailed pain diary (below) and rate their pain from 0 (no pain) to 10 (extreme pain) every day.
If a patient’s pain was not at least 30% lower on the pain scale after 2 weeks, or the patient experienced GI pain or discomfort, the patient stopped taking OrthoNova® AF with the help of the doctor and left the study.
What Were the Study Results?
Did Orthonova®
AF provide relief?
Yes, Orthonova® AF had a significant impact on reducing joint discomfort and stiffness for most patients. The graph below shows the results for each patient group, in aggregate:
Yes, Orthonova® AF had a significant impact on reducing joint discomfort and stiffness for most patients. The graph below shows the results for each patient group, in aggregate:
1. The X axis represents patient pain level; with 10 being the greatest pain and 0 being no pain.
2. The Y axis contains the patient group and their weekly results
3. Each color bar represents a trial week; week 0 (blue) is the stated pain level reported at the start - before taking OrthoNova® AF
Patient group 2020-L2-003 reported the most dramatic change with an initial reported pain level of 8 being reduced to 1 after five weeks, with a two-a-day dosage. That represents a pain reduction of 80% over the baseline (first day measurement) of the trial. For all patient groups, a median of 7 was the baseline, with a median of 2 at the conclusion of the trial. This represents a median pain improvement of 72% in aggregate. Group 2020-L2-006 had the least pain reduction, but was still at a 67% reduction from the baseline. No group reported pain stasis or increase, and all groups reported pain reduction and mobility gains of some level.
2. The Y axis contains the patient group and their weekly results
3. Each color bar represents a trial week; week 0 (blue) is the stated pain level reported at the start - before taking OrthoNova® AF
4. Each patient group reported different joints with different degrees of pain. This graph represents the group, as a whole.
Did Orthonova® AF Help in Other Ways?
In a surprising and unanticipated result, a number of patients reported skin appearance improvements, as well as the disappearance of significant skin blemishes and, in some cases, warts and other dermatological conditions. This result clearly requires separate study, but is a suprisingly desirable and welcomed benefit.
Most patients who finished the study felt dramatically better than when they started. Patients had less joint pain, stiffness and discomfort. Many patients also reported the resumption of physical activities that they had abandoned and also said their daily activities were easier to complete because moving was easier.
What Side Effects Did Patients Have?
In this study, two patients (4% of the study participants) reported GI discomfort. Both of those patients discontinued their participation in the study. One additional patient reported mild GI discomfort, that quickly resolved, and continued the study. Patients who experienced any GI discomfort were encouraged to take OrthoNova® AF veggie-capsules with food.
A side effect is any medical problem caused by a drug or treatment. A lot of research is needed to know whether a treatment causes a problem. So, when new treatments are being studied, researchers keep track of all problems that patients have.
Patient Comments
• “By week 2 I could do squats and lunges and push-ups. Last week I could not.”
• “Much less inflammation after week 3! Thank you so much!”
• “Was able to go to the gym for the first time in over three weeks.”
• “Movements are easier and there’s less inflammation than usual.”
• “Less pain overall/feeling back to normal and can do all my regular activities.”
• “Can do yoga again – my neck has decreased stiffness.”
• “Have noticed improvement in my skin.”
• “I had 2 painful plantar warts for 20 years that simply disappeared after 3rd week. Wow!”
• “Have noticed my pain increasing since I stopped taking the product for the trial – can I get more?”
• “Much less inflammation after week 3! Thank you so much!”
• “Was able to go to the gym for the first time in over three weeks.”
• “Movements are easier and there’s less inflammation than usual.”
• “Less pain overall/feeling back to normal and can do all my regular activities.”
• “Can do yoga again – my neck has decreased stiffness.”
• “Have noticed improvement in my skin.”
• “I had 2 painful plantar warts for 20 years that simply disappeared after 3rd week. Wow!”
• “Have noticed my pain increasing since I stopped taking the product for the trial – can I get more?”
Orthonova® and the Orthonova logo are registered U.S. trademarks. U.S. Patent 11,324,246