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

Research output: Contribution to journalArticle

34 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)615-622
Number of pages8
JournalInternational Journal of Medical Sciences
Volume8
Issue number7
StatePublished - Oct 12 2011

Fingerprint

Knee Osteoarthritis
Placebos
Boswellia
Osteoarthritis
Pain
Aptitude
Aflapin
Clinical Studies
Ontario
Visual Analog Scale
Anti-Inflammatory Agents
Clinical Trials
Urine
Safety
Serum

Keywords

  • Aflapin
  • Boswellia serrata
  • Clinical study
  • Osteoarthritis
  • Visual Analog Scale

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{fbde73f243ee4dbe933e0c6363a1a4f9,
title = "A double blind, randomized, placebo controlled clinical study evaluates the early efficacy of Aflapin{\circledR} in subjects with osteoarthritis of knee",
abstract = "Aflapin{\circledR} 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{\circledR} and traditional 65{\%} Boswellia extract. A 30-day, double-blind, randomized, placebo-controlled study was conducted to validate the efficacy of Aflapin{\circledR} 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{\circledR} 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.",
keywords = "Aflapin, Boswellia serrata, Clinical study, Osteoarthritis, Visual Analog Scale",
author = "Vishal, {Amar A.} and Artatrana Mishra and Raychaudhuri, {Siba P}",
year = "2011",
month = "10",
day = "12",
language = "English (US)",
volume = "8",
pages = "615--622",
journal = "International Journal of Medical Sciences",
issn = "1449-1907",
publisher = "Ivyspring International Publisher",
number = "7",

}

TY - JOUR

T1 - A double blind, randomized, placebo controlled clinical study evaluates the early efficacy of Aflapin® in subjects with osteoarthritis of knee

AU - Vishal, Amar A.

AU - Mishra, Artatrana

AU - Raychaudhuri, Siba P

PY - 2011/10/12

Y1 - 2011/10/12

N2 - 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.

AB - 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.

KW - Aflapin

KW - Boswellia serrata

KW - Clinical study

KW - Osteoarthritis

KW - Visual Analog Scale

UR - http://www.scopus.com/inward/record.url?scp=80054756699&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80054756699&partnerID=8YFLogxK

M3 - Article

VL - 8

SP - 615

EP - 622

JO - International Journal of Medical Sciences

JF - International Journal of Medical Sciences

SN - 1449-1907

IS - 7

ER -