Condition category
Musculoskeletal Diseases
Date applied
05/09/2009
Date assigned
06/04/2010
Last edited
14/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Amar Anand Vishal

ORCID ID

Contact details

Department of Orthopaedics
ASR Academy of Medical Sciences
Eluru
534 002
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09-002/Aflapin®/OA

Study information

Scientific title

Efficacy of Aflapin® in the treatment of osteoarthritis of knee: a randomised, double-blind placebo controlled clinical study

Acronym

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).

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Osteoarthritis

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Aflapin®

Primary outcome measures

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 measures

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.

Overall trial start date

01/09/2009

Overall trial end date

01/11/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Sixty (60)

Participant 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

Recruitment start date

01/09/2009

Recruitment end date

01/11/2009

Locations

Countries of recruitment

India

Trial participating centre

Department of Orthopaedics
Eluru
534 002
India

Sponsor information

Organisation

Laila Impex R&D Center (India)

Sponsor details

Unit 1 Phase III
Jawahar Autonagar
Vijayawada
520007
India

Sponsor type

Industry

Website

http://lailaimpex.tradeindia.com/

Funders

Funder type

Industry

Funder name

Laila Impex R&D Center (India)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22022214

Publication citations

  1. Results

    Vishal AA, Mishra A, Raychaudhuri SP, A double blind, randomized, placebo controlled clinical study evaluates the early efficacy of aflapin in subjects with osteoarthritis of knee., Int J Med Sci, 2011, 8, 7, 615-622.

Additional files

Editorial Notes