Welcome
Support Centre
26 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Efficacy of Aflapin® in the treatment of osteoarthritis of knee
ISRCTN ISRCTN69643551
DOI 10.1186/ISRCTN69643551
ClinicalTrials.gov identifier
EudraCT number
Public title Efficacy of Aflapin® in the treatment of osteoarthritis of knee
Scientific title Efficacy of Aflapin® in the treatment of osteoarthritis of knee: a randomised, double-blind placebo controlled clinical study
Acronym N/A
Serial number at source 09-002/Aflapin®/OA
Study hypothesis Aflapin® is an improved novel composition of Boswellia serrata extract standardised to 30% 3-O-acetyl-11-keto-beta-boswellic acid (BE-30). Pre-clinical studies demonstrate that Aflapin® is up to 25% more bioavailable than BE-30. Therefore, we hypothesise that Aflapin® would provide faster relief form clinical symptoms of osteoarthritis (OA).

Results of a related study with BE-30 against osteoarthritis can be found at: http://www.ncbi.nlm.nih.gov/pubmed/18667054 (this trial is registered with ISRCTN05212803).
Lay summary Not provided at time of registration
Ethics approval Institutional Review Board (IRB) of Alluri Sitarama Raju Academy of Medical Sciences (ASRAM) approved on the 1st August 2009.
Study design Randomised placebo-controlled trial
Countries of recruitment India
Disease/condition/study domain Osteoarthritis
Participants - inclusion criteria 1. Participants must understand risks and benefits of the protocol and able to give informed consent
2. Male and female subjects of 40 - 80 years of age
3. Females of child bearing potential must agree to use an approved form of birth control and have a negative pregnancy test result
4. Unilateral or bilateral OA of the knee for more than 3 months
5. Visual Analogue Scale (VAS) score during the most painful knee movement between 40 - 70 mm after 7 day withdrawal of usual medication
6. Lequesne's Functional Index (LFI) score greater than 7 points after 7 days of withdrawal of usual medication
7. Ability to walk
8. Availability for the duration of the entire study period
Participants - exclusion criteria 1. History of underlying inflammatory arthropathy or severe rheumatoid arthritis (RA)
2. Hyperuricemia (greater than 440 umol/L) and/or past history of gout
3. Recent injury in the area affected by OA of the knee (past 4 months) and expectation of surgery in the next 4 months
4. Intra-articular corticosteroid injections within the last 3 months
5. Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), abnormal liver or kidney function tests, history of peptic ulceration and upper gastrointestinal (GI) haemorrhage, congestive heart failure, hypertension, hyperkalemia
6. Major abnormal findings on complete blood count, history of coagulopathies, haematological or neurological disorders
7. High alcohol intake (greater than 2 standard drinks per day)
8. Pregnant, breastfeeding or planning to become pregnant during the study
9. Use of concomitant prohibited medication other than ibuprofen
10. Obesity: body mass index (BMI) more than 30 kg/m^2
Anticipated start date 01/09/2009
Anticipated end date 01/11/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Sixty (60)
Interventions 60 subjects randomised into 2 groups (n = 30):
1. Aflapin® (oral) 50 mg twice daily (bid)
2. Placebo

Ibuprofen will be used as a rescue medication for both groups. The study duration is 30 days and evaluations will be at baseline, 5, 15 and 30 days.
Primary outcome measure(s) 1. Pain, assessed by VAS
2. LFI
3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-pain, WOMAC-stiffness and WOMAC-physical ability

Measured at baseline, 5, 15 and 30 days of the study.
Secondary outcome measure(s) 1. Tumor necrosis factor alpha (TNFa)
2. C-reactive protein (CRP)
3. Matrix metelloproteinase-3 (MMP-3)

Measured at baseline, 5, 15 and 30 days of the study.
Sources of funding Laila Impex R&D Center (India)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22022214
Contact name Dr  Amar Anand  Vishal
  Address Department of Orthopaedics
ASR Academy of Medical Sciences
  City/town Eluru
  Zip/Postcode 534 002
  Country India
Sponsor Laila Impex R&D Center (India)
  Address Unit 1 Phase III
Jawahar Autonagar
  City/town Vijayawada
  Zip/Postcode 520007
  Country India
  Sponsor website: http://lailaimpex.tradeindia.com/
Date applied 05/09/2009
Last edited 14/02/2012
Date ISRCTN assigned 06/04/2010
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.