Efficacy of Aflapin® in the treatment of osteoarthritis of knee
| ISRCTN | ISRCTN69643551 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69643551 |
| Secondary identifying numbers | 09-002/Aflapin®/OA |
- Submission date
- 05/09/2009
- Registration date
- 06/04/2010
- Last edited
- 14/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Amar Anand Vishal
Scientific
Scientific
Department of Orthopaedics
ASR Academy of Medical Sciences
Eluru
534 002
India
Study information
| Study design | Randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy of Aflapin® in the treatment of osteoarthritis of knee: a randomised, double-blind placebo controlled clinical study |
| 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(s) | Institutional Review Board (IRB) of Alluri Sitarama Raju Academy of Medical Sciences (ASRAM) approved on the 1st August 2009. |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aflapin® |
| Primary outcome measure | 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 study start date | 01/09/2009 |
| Overall study end date | 01/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Sixty (60) |
| 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 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
Study participating centre
Department of Orthopaedics
Eluru
534 002
India
534 002
India
Sponsor information
Laila Impex R&D Center (India)
Industry
Industry
Unit 1 Phase III
Jawahar Autonagar
Vijayawada
520007
India
| Website | http://lailaimpex.tradeindia.com/ |
|---|---|
"ROR" |
https://ror.org/05q6g7072 |
Funders
Funder type
Industry
Laila Impex R&D Center (India)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2011 | Yes | No |
