Healthy Joint Support

HEALTHY JOINT SUPPORT

Healthy Joint Support

ParActin® inhibits NF-kB activity and reduces the DNA binding of NF-kB,
thereby reducing pro-infl ammatory cytokines and enzymes such as COX-2
and prostaglandin that cause pain and infl ammation in the body (2). In vitro
research has shown ParActin® to be a natural COX-2 inhibitor without causing stomach discomfort or increased risk of heart attack and stroke in users.

Rheumatoid arthritis (RA) results from the immune system mistakenly
attacking healthy joints for a prolonged period of time, causing a great deal of
inflammation. Individuals with RA typically have high levels of C-reactive protein (CRP), which is involved in acute and chronic inflammatory activity in unhealthy joints. Rheumatoid factors (RFs) are antibodies detectable in the blood of approximately 80% of adults with RA. RFs are produced by an immune system that can attack healthy tissue in your body. Tumor necrosis factor-alpha (TNF-α), another key driver of inflammation, is a cytokine that stimulates an acute reaction. Research has found TNF-α to be present in the synovial fluid of RA patients. Andrographolide is known to reduce TNF-α, which leads to a significant reduction in RFs.

Human Clinical Study 1

Clin Rheumatol, DOI 10.1007/s10067-009-1180-5

Efficacy of an Andrographis paniculata composition for the relief of rheumatoid arthritis symptoms: a prospective randomized placebo-controlled trial

A. Burgos & J. L. Hancke & J. C. Bertoglio &
Aguirre & S. Arriagada & M. Calvo & D. D. Cáceres

Received: 2 December 2008 / Revised: 13 February 2009 / Accepted: 27 March 2009 # Clinical Rheumatology 2009

In a 2009 randomized, double-blind and placebo-controlled study published in Clinical Rheumatology, 60 individuals with compromised joints were given 100 mg of ParActin® or placebo in conjunction with methotrexate (MTX), three times a day for 14 weeks (3). MTX, a standard therapy for RA, improves the number of tender and swollen joints, pain and functional status, but longterm use of MTX may cause serious infection and liver damage.

ParActin® was effective in reducing the number and total grade of swollen joints, the number and total grade of tender joints, as well as improving scores on HAQ-52, and SF-36 health questionnaires. Its effect was associated with a reduction of RF, creatine kinase, IgA-RF and IgM-RF. IgA and IgM are antibodies made by the body’s immune system in response to a foreign substance attack such as bacteria, viruses and fungus. Patients with RA typically have elevated levels of RF, IgA-RF, IgM-RF and CRP. The reduction in IgA-RF and IgM-RF is beneficial because their excess is positively correlated with cartilage damage.

Findings

The ParActin® group showed signifi cant improvement compared to the
placebo (with MTX) group in the following scores (see Figure 4):

• Number of swollen joints: nine in the ParActin® group versus 13 in the
placebo group
• Total grade of swollen joints: 11 in the
ParActin® group versus 16 in the placebo group
• Total grade of tender joints: 14 in the
ParActin® group versus 17 in the placebo group
• HAQ: 19 in the ParActin® group versus 24 in the placebo group
• Reduction of RF: 119 in the ParActin® group versus 130 in the placebo
group
• Reduction in IgA: 293.7 in the ParActin® versus 335 in the placebo
group

The study concluded that ParActin® is significantly effective at reducing
symptoms and serological parameters and therefore is useful as a complementary natural treatment for rheumatoid arthritis.

Data

Figure 4: Effect of Andrographolide on Joint Comfort Over Time versus Placebo. Table depicts number of patients at risk per group over time. Adapted from Burgos et al. (3).

Human Clinical Study 2

Innovative Rheumatology 2019 Chapter 11

Andrographolide a New Potential Drug for the Long Term Treatment of Rheumatoid Arthritis Disease

María A. Hidalgo, Juan L. Hancke, Juan C. Bertoglio and Rafael A. Burgos

In another human clinical trial published in Innovative Rheumatology, eight individuals with various rheumatoid conditions were given 300 mg of ParActin® daily for four years (4). Supplementation with ParActin® showed significant improvements in the number of swollen joints, total grade of swollen joints, total grade of tender joints and quality of life. Also noted were significant reductions in RF, erythrocytes sedimentation rate and CRP. Furthermore, serum immunological parameters of inflammation were reduced progressively during 48 months of ParActin® supplementation (see Figure 5a).

ParActin® may also have additional therapeutic effects over prednisone and MTX in easing pain and fatigue. Research suggests that Andrographolide inhibits the COX-2 enzyme and reduces prostaglandin production tied to pain and inflammation (see Figure 5b).

After 24 months of taking ParActin®, six individuals progressed to supplementing with ParActin® as their only therapeutic. No side effects were observed, indicating ParActin® was safe, nontoxic and well tolerated (4) (see Figure 5c).

Data

Figure 5: Effect of ParActin® in Patients with Chronic Rheumatoid Arthritis. Adapted from Hildalgo et al. (4).

Human Clinical Study 3

In a double-blind, randomized, placebo-controlled study, 103 subjects with Osteoarthritis (mild to moderate knee joint pain), were given either

ParActin® in high dose (600mg/day (n=33), ParActin® in low dose (300mg/day) (n=35), or placebo (n=35) for 12 weeks.

Primary objective of the study is to evaluate the effect of ParActin® on joint pain as measured by a change from the baseline to Day 84 in knee joint WOMAC pain.

Secondary objectives include the evaluation of ParActin® on joint stiffness & physical function as measured by WOMAC, quality of life as measured by SF-36 Quality of life questionnaire, fatigue level as measured by FACIT Fatigue Scale, the difference in mean rescue medication consumption, and safety of ParActin®.

WOMAC pain score showed significant improvement from baseline to end of 84 days of treatment. This observation shows that ParActin® is efficacious at both low as well as high dose in reducing the joint pain in mild to moderate knee osteoarthritis when compared with the placebo

WOMAC stiffness and physical function scores showed significant improvement in both ParActin® treated groups.

Quality of life scores as measured by SF-36 questionnaire showed increasing trend in both the treated groups while decreasing trend in the placebo group. The FACIT Fatigue scores show gradual improvement in both the treated groups compared to decreasing trend in placebo.