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Clinical Studies

The safety & effectiveness of Ginflex® is backed by multiple clinical studies. Ginflex® is a 100% plant-based joint supplement that combines 4 natural ingredients – Winter Cherry, Ginger, AFLAPIN™, and CAVACURMIN® – to deliver impressive results. AFLAPIN™, a patented Boswellia Serrata, relieves pain & restores physical function within 5-7 days. CAVACURMIN®, a patented Turmeric extract proven to offer 40 times better bioavailability than other Turmeric extracts. The combination of these 4 superior ingredients and high quality manufacturing process drive Ginflex®'s swift and potent pain relief.

 

Explore the dropdown menus below to view the full clinical studies behind Ginflex®'s proven formula.

A close-up view of green liquid in test tubes hints at the meticulous research behind Ginflex®.
  • Cellular and molecular mechanisms of anti-inflammatory effect of Aflapin™: a novel Boswellia serrata extract

     

    Krishanu Sengupta, Jayaprakash N. Kolla, Alluri V. Krishnaraju, Nandini Yalamanchili, Chirravuri V. Rao, Trimurtulu Golakoti, Smriti Raychaudhuri, Siba P. Raychaudhuri

     

    Mol Cell Biochem. 2011; 354: 189-197

     

    Abstract: There is significant number of evidences suggesting the anti-inflammatory properties of gum resin extracts of Boswellia Serrata containing 3-O-acetyl-11-ketob-boswellic acid (AKBA) and their promising potential as therapeutic interventions against inflammatory diseases such as osteoarthritis (OA).

     

    Unfortunately, the poor bioavailability of AKBA following oral administration might limit the anti-inflammatory efficacy of standardized Boswellia extract(s). To address this issue, we describe a novel composition called Aflapin™, which contains B. serrata extract enriched in AKBA and non-volatile oil portion of B. serrata gum resin. Our observations show that the availability of AKBA in systemic circulation of experimental animals is increased by 51.78% in Aflapin™-supplemented animals, in comparison with that of 30% AKBA standardized extract or BE-30 (5-Loxin®).

     

    Consistently, Aflapin™ confers better anti-inflammatory efficacy in Freund’s Complete Adjuvant (FCA)-induced inflammation model of Sprague–Dawley rats. Interestingly, in comparison with BE-30, Aflapin™ also provides significantly better protection from IL-1b-induced death of human primary chondrocytes and improves glycosaminoglycans production in human chondrocytes. In Tumor necrosis factor alpha (TNFa)-induced human synovial cells, the inhibitory potential of Aflapin™ (IC50 44.736 ng/ml) on matrix metalloproteinase-3 (MMP-3) production is 14.83% better than that of BE-30 (IC50 52.528 ng/ml).

     

    In summary, our observations collectively suggest that both the Boswellia products, BE-30 (5-Loxin®) and Aflapin™, exhibit powerful anti-inflammatory efficacy and anti-arthritic potential. In particular, in comparison with BE-30, Aflapin™ provides more potential benefits in recovering articular cartilage damage or protection from proteolytic degradation due to inflammatory insult in arthritis such as osteoarthritis or rheumatoid arthritis.

  • A Double Blind, Randomized, Placebo Controlled Clinical Study Evaluates the Early Efficacy of Aflapin™ in Subjects with Osteoarthritis of Knee

     

    Amar A. Vishal, Artatrana Mishra, Siba P Raychaudhuri

     

    International Journal of Medical Sciences. 2011; 8(7): 615-622


    Abstract: Aflapin™ is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin™ is more efficacious as an anti-inflammatory agent compared to the existing Boswellia products, 5-Loxin® and traditional 65% Boswellia extract. A 30-day, double-blind, randomized, placebo-controlled study was conducted to validate the efficacy of Aflapin™ in the management of clinical symptoms of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN69643551). Sixty eligible OA subjects selected through screening were included in the study. The subjects received either 100 mg (n=30) of Aflapin™ or placebo (n=30) daily for 30 days. Each subject was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 5, 15 and 30. A series of biochemical tests in serum, urine and hematological parameters established the safety of Aflapin™. The observations suggest that Aflapin™ conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Aflapin™ provided significant improvements in pain score and functional ability in as early as 5 days of treatment. In conclusion, our observations suggest that Aflapin™ is a safe, fast acting and effective alternative intervention in the management of OA.

  • Comparative Efficacy and Tolerability of 5-Loxin® and Aflapin™ Against Osteoarthritis of the Knee: A Double Blind, Randomized, Placebo Controlled Clinical Study

     

    Krishanu Sengupta, Alluri V. Krishnaraju, Amar A. Vishal, Artatrana Mishra, Golakoti Trimurtulu, Kadainti VS Sarma, Smriti K Raychaudhuri, Siba P Raychaudhuri

     

    International Journal of Medical Sciences. 2010; 7(6): 366-377

     

    Abstract: Aflapin™ is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin™ is significantly better as an anti-inflammatory agent compared to the Boswellia extracts presently available in the market. A 90-day, double-blind, randomized, placebo-controlled study was conducted to evaluate the comparative efficacy and tolerability of 5-Loxin® and Aflapin™ in the treatment of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN80793440). 60 OA subjects were included in the study.

     

    The subjects received either 100 mg ( n=20) of 5 -Loxin® or 100 mg (n=20) of Aflapin™ or a placebo (n=20) daily for 90 days. Each patient was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 7, 30, 60 and 90. A battery of biochemical parameters in serum, urine and hematological parameters in citrated whole blood were performed to assess the safety of 5-Loxin® and Aflapin™ in OA subjects. 57 subjects completed the study. At the end of the study, both 5-Loxin® and Aflapin™ conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects.

     

    Interestingly, significant improvements in pain score and functional ability were recorded as early as 7 days after initiation of the study in the treatment group supplemented with 100 mg Aflapin™. Corroborating the improvements in pain scores in treatment groups, our in vitro studies provide evidences that Aflapin™ is capable of inhibiting cartilage degrading enzyme MMP-3 and has the potential to regulate the inflammatory response by inhibiting ICAM-1. Aflapin™ and 5-Loxin® reduce pain and improve physical functions significantly in OA subjects. Aflapin™ exhibited better efficacy compared to 5-Loxin®. In comparison with placebo, the safety parameters were almost unchanged in the treatment groups. Hence both 5-Loxin® and Aflapin™ are safe for human consumption.

  • Enhanced metabolic bioavailability of tetrahydrocurcumin after oral supplementation of a γ-cyclodextrin curcumin complex

     

    Christian Hundshammer, Christiane Sch¨on, Madoka Kimura, Takahiro Furune, Keiji Terao, Dana Elgeti, Rachela Mohr

     

    Journal of Functional Foods. 2021; 79: 104410


    Abstract: Tetrahydrocurcumin, curcumin’s main metabolite, exhibits properties similar to curcumin with superior effectiveness in certain categories. However, as curcumin’s bioavailabilty and in vivo conversion are low, formulations yielding appreciable tetrahydrocurcumin concentrations are required to convey potential health benefits either through tetrahydrocurucmin itself, complementary or synergistic to curcumin. Here, we conducted a study with humans orally receiving γ-cyclodextrin complexed curcumin for 12 weeks daily and analyzed the metabolic bioavailability of tetrahydrocurcumin.

     

    Notably, supplementation yielded threefold higher serum tetrahydrocurcumin compared to curcumin already after 4 weeks. In fact, this is in line with previously unpublished data demonstrated here revealing an increased metabolic bioavailability (BA = 39.8) of tetrahydrocurcumin. Foremost we show that γ-cyclodextrin enhances the oral and metabolic bioavailability of curcumin and tetrahydrocurcumin, respectively. This is likely related to an improved uptake of cyclodextrin complexed curcumin corroborated by enclosed in vitro studies, its metabolic turnover and the prolonged plasma half-life of tetrahydrocurcumin.

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