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A double blind, randomized, placebo controlled clinical study evaluates the early efficacy of aflapin in subjects with osteoarthritis of knee.

Vishal AA, Mishra A, Raychaudhuri SP - Int J Med Sci (2011)

Bottom Line: A series of biochemical tests in serum, urine and hematological parameters established the safety of Aflapin.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Orthopedics, Alluri Sitarama Raju Academy of Medical Sciences, National Highway 5, Eluru, 534 002, India.

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.

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Pain, Function and stiffness scores. Presented are the mean scores for (a) visual analog scale, (b) Lequesne's Functional Index, (c) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-pain, (d) WOMAC-stiffness, and (e) WOMAC-function in placebo and 100 mg/day Aflapin® groups at different time points day 0, day 5, day 15 and day 30. Each bar represents mean ± standard deviation. In comparison with placebo the mean scores in the treatment groups were tested for significance using Wilcoxon's rank-sum test; * p < 0.05 and # p < 0.01.
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Figure 2: Pain, Function and stiffness scores. Presented are the mean scores for (a) visual analog scale, (b) Lequesne's Functional Index, (c) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-pain, (d) WOMAC-stiffness, and (e) WOMAC-function in placebo and 100 mg/day Aflapin® groups at different time points day 0, day 5, day 15 and day 30. Each bar represents mean ± standard deviation. In comparison with placebo the mean scores in the treatment groups were tested for significance using Wilcoxon's rank-sum test; * p < 0.05 and # p < 0.01.

Mentions: Significant (p<0.05) reduction in all the pain scores was observed in the Aflapin group by day 30, when compared to the placebo group. In comparison with placebo, supplementation of Aflapin for 30 days conferred 37.6, 32.0, 40.1, 41.3 and 38.8 percent reductions in VAS, LFI, WOMAC pain, WOMAC stiffness and WOMAC function scores, respectively. Interestingly, significant (p<0.05) reductions in VAS and LFI scores were also observed in Aflapin group over placebo by day 5. Aflapin supplementation showed 14.8 and 16.3 percent better reduction in VAS and LFI scores respectively over placebo by 5th day. Compared to the placebo group, the reductions in WOMAC scores were not significant after 5 days of treatment. Aflapin supplementation for 30 days afforded highly significant (p<0.001) reductions in all the pain scores exhibiting 49.1, 34.4, 49.5, 48.4 and 45.2 percent reduction, in VAS, LFI, WOMAC pain, WOMAC stiffness and WOMAC function scores, respectively, when compared to the baseline. However, significant (p<0.05) reductions were observed in VAS, WOMAC pain and WOMAC function scores in placebo group when compared to the base line and the magnitude of the reductions are 17.6, 12.0 and 9.24 percent respectively; which are small in comparison with those of the Aflapin group (figure 2).


A double blind, randomized, placebo controlled clinical study evaluates the early efficacy of aflapin in subjects with osteoarthritis of knee.

Vishal AA, Mishra A, Raychaudhuri SP - Int J Med Sci (2011)

Pain, Function and stiffness scores. Presented are the mean scores for (a) visual analog scale, (b) Lequesne's Functional Index, (c) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-pain, (d) WOMAC-stiffness, and (e) WOMAC-function in placebo and 100 mg/day Aflapin® groups at different time points day 0, day 5, day 15 and day 30. Each bar represents mean ± standard deviation. In comparison with placebo the mean scores in the treatment groups were tested for significance using Wilcoxon's rank-sum test; * p < 0.05 and # p < 0.01.
© Copyright Policy
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC3198257&req=5

Figure 2: Pain, Function and stiffness scores. Presented are the mean scores for (a) visual analog scale, (b) Lequesne's Functional Index, (c) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-pain, (d) WOMAC-stiffness, and (e) WOMAC-function in placebo and 100 mg/day Aflapin® groups at different time points day 0, day 5, day 15 and day 30. Each bar represents mean ± standard deviation. In comparison with placebo the mean scores in the treatment groups were tested for significance using Wilcoxon's rank-sum test; * p < 0.05 and # p < 0.01.
Mentions: Significant (p<0.05) reduction in all the pain scores was observed in the Aflapin group by day 30, when compared to the placebo group. In comparison with placebo, supplementation of Aflapin for 30 days conferred 37.6, 32.0, 40.1, 41.3 and 38.8 percent reductions in VAS, LFI, WOMAC pain, WOMAC stiffness and WOMAC function scores, respectively. Interestingly, significant (p<0.05) reductions in VAS and LFI scores were also observed in Aflapin group over placebo by day 5. Aflapin supplementation showed 14.8 and 16.3 percent better reduction in VAS and LFI scores respectively over placebo by 5th day. Compared to the placebo group, the reductions in WOMAC scores were not significant after 5 days of treatment. Aflapin supplementation for 30 days afforded highly significant (p<0.001) reductions in all the pain scores exhibiting 49.1, 34.4, 49.5, 48.4 and 45.2 percent reduction, in VAS, LFI, WOMAC pain, WOMAC stiffness and WOMAC function scores, respectively, when compared to the baseline. However, significant (p<0.05) reductions were observed in VAS, WOMAC pain and WOMAC function scores in placebo group when compared to the base line and the magnitude of the reductions are 17.6, 12.0 and 9.24 percent respectively; which are small in comparison with those of the Aflapin group (figure 2).

Bottom Line: A series of biochemical tests in serum, urine and hematological parameters established the safety of Aflapin.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Orthopedics, Alluri Sitarama Raju Academy of Medical Sciences, National Highway 5, Eluru, 534 002, India.

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.

Show MeSH
Related in: MedlinePlus