Comparative efficacy of Boswellia serrata extract and 5-Loxin® in the treatment of osteoarthritis of knee: a randomised, double-blind placebo-controlled clinical study

ISRCTN ISRCTN35444380
DOI https://doi.org/10.1186/ISRCTN35444380
Secondary identifying numbers 08-001/5-Lo, BE/OA
Submission date
13/09/2008
Registration date
09/10/2008
Last edited
09/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Amar Anand Vishal
Scientific

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

Study information

Study designRandomised placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesBoswellia serrata extract have been proven to be effective against inflammatory disorders in clinical trials, but no comparative clinical investigation has been carried out to demonstrate the efficacy and underlying mechanistic pathways involved therein. Furthermore, a broad spectrum of studies have evidenced that non-steroidal anti-inflammatory drugs (NSAIDs) induce painful gastrointestinal irritation as well as bleeding. No such adverse effects have been reported for natural Boswellia products.

In recent past, we have developed and proved clinical efficacy of a novel Boswellia serrata extract (5-Loxin®) enriched with 30% acetyl-11-keto-beta boswellic acid (AKBA) (Pending US patent [ref: 2004/0073060A1], Indian patent [ref: 205269], Australian patent [2002242934]). In a published clinical study (http://www.ncbi.nlm.nih.gov/pubmed/18667054; registered with ISRCTN05212803), we have shown that oral administration of 5-Loxin® conferred significant improvement in clinical signs and symptoms of patients with osteoarthristis (OA) of knee. This study also suggests that 5-Loxin® can normalise the elevated Matrix metalloproteinase-3 enzyme in synovial fluid which helps to reduce the cartilage degradation in OA.

However, till date no clinical study has been reported the comparative efficacy of 5-Loxin® and Boswellia serrata extract in OA. Therefore, in the present clinical study we designed to assess comparative efficacy of 5-Loxin® with Boswellia serrata extract (BE) against OA of knee.
Ethics approval(s)This protocol was approved by the Institutional Review Board of Alluri Sitarama Raju Academy of Medical Sciences (ASRAM) on 16/07/2008 (ref: 08-001 / 5-LO, BE/OA).
Health condition(s) or problem(s) studiedOsteoarthritis of knee
Intervention75 subjects randomised into 3 groups (n = 25):
1. 5-Loxin® (oral), 50 mg twice daily (bid)
2. Boswellia extract (oral), 500 mg bid
3. Placebo

Ibuprofen was used as a rescue medication for all groups. The study duration is 90 days and evaluations are at baseline, 7, 30, 60 and 90 days.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Boswellia serrata extract (5-Loxin®)
Primary outcome measure1. Pain, assessed with VAS
2. LFI
3. Western Ontario and McMaster Universities osteoarthritis index (WOMAC)-pain, WOMAC-stiffness and WOMAC-physical ability

All primary outcomes will be measured at baseline, 7, 30, 60 and 90 days of the study.
Secondary outcome measures1. C-Reactive Protein (CRP)
1. Matrix Metelloproteinase-3 (MMP-3)

The secondary outcomes will be measured at baseline, 7, 30, 60 and 90 days of the study.
Overall study start date15/09/2008
Completion date14/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants75
Key inclusion criteria1. 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
Key exclusion criteria1. 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 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
Date of first enrolment15/09/2008
Date of final enrolment14/12/2008

Locations

Countries of recruitment

  • India

Study participating centre

Department of Orthopaedics
Eluru
534 002
India

Sponsor information

Laila Impex (India)
Industry

R&D Center
Unit 1 Phase III
Jawahar Autonagar
Vijayawada
520007
India

Phone +91 866 254 5244
Email lailarescen@sify.com
Website http://lailaimpex.tradeindia.com
ROR logo "ROR" https://ror.org/05q6g7072

Funders

Funder type

Industry

Laila Impex (India)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan