Condition category
Musculoskeletal Diseases
Date applied
13/09/2008
Date assigned
09/10/2008
Last edited
09/10/2008
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

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 measures

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

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

http://lailaimpex.tradeindia.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes