Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
08-001/5-Lo, BE/OA
Study information
Scientific title
Acronym
Study hypothesis
Boswellia 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
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).
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 of knee
Intervention
75 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 type
Drug
Phase
Not Specified
Drug names
Boswellia serrata extract (5-Loxin®)
Primary outcome measure
1. 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 measures
1. 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 trial start date
15/09/2008
Overall trial end date
14/12/2008
Reason abandoned (if study stopped)
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
75
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 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
Recruitment start date
15/09/2008
Recruitment end date
14/12/2008
Locations
Countries of recruitment
India
Trial participating centre
Department of Orthopaedics
Eluru
534 002
India
Sponsor information
Organisation
Laila Impex (India)
Sponsor details
R&D Center
Unit 1 Phase III
Jawahar Autonagar
Vijayawada
520007
India
+91 866 254 5244
lailarescen@sify.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Laila Impex (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
Basic results (scientific)
Publication list