Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Rama Sathish Andey


Contact details

Department of Orthopaedics
ASR Academy of Medical Sciences
534 002
+91 (0)881 224 9361

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


5-Loxin® OA clinical trial

Study hypothesis

5-Loxin® is a novel Boswellia serrata extract enriched to 30% 3 Acetyl-11-Keto-beta-Boswellic Acid (AKBA) (United States [US] Patent 2004/0073060A1). In carrageenan induced inflammation model, 5-Loxin® confers a significant improvement in paw inflammation in albino Wister rats. Cell based in vitro studies and in vivo experiments conducted in Sprague Dawley rats demonstrate that 5-Loxin® potentially inhibits the pro-inflammatory cytokines such as Tumour Necrotising Factor (TNF)-alpha and Interleukin-1 (IL-1)-beta (yet to be published). Furthermore, affimatrix gene chip analysis demonstrates 5-Loxin® can potentially inhibit the TNF-alpha induced gene expression of Matrix Metalloproteinases (MMPs), adhesion molecules such as Inter-Cellular Adhesion Molecule-1 (ICAM-1), Vascular Cell Adhesion Molecule-1 (VCAM-1) and mediators of apoptosis in human micro vascular endothelial cells. Importantly, extensive studies on acute and dose-dependent sub-chronic safety experiments on rats demonstrate that 5-Loxin® does not exhibit toxic manifestations even at a dose 2000 - 3000 times higher than the Human Equivalence Dose (HED). In addition, 5-Loxin® does not show genotoxicity in the standard Ames bacterial reverse mutation assay (INTOX, study no. 4477/05).

Therefore, in the present investigation, in a double-blind and placebo controlled clinical study we sought to evaluate the efficacy and safety of 5-Loxin® in treatment of Osteoarthritis (OA) of the knee.

Ethics approval

This protocol was approved by the Ethics Committee (Institutional Review Board [IRB]) of Alluri Sitarama Raju Academy of Medical Sciences (ASRAM) (India) on the 26th April 2006 (ref: # ASRAM IRB#06-001).

Study design

Randomised, placebo controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Osteoarthritis of knee


75 subjects randomised into 3 groups (n = 25):
1. 5-Loxin® 2 x 50 mg/day twice daily (bid)
2. 5-Loxin® 2 x 125 mg/day (bid)
3. Placebo

Ibuprofen was used as a rescue medication for all groups. The study duration was 90 days and evaluations were at baseline, 7, 30, 60 and 90 day.

Intervention type



Not Specified

Drug names

5-Loxin® (Boswellia serrata extract)

Primary outcome measure

1. Visual Analog Scale (VAS)
2. Lequesne Functional Index (LFI)
3. Western Ontario and McMaster Universities osteoarthritis index (WOMAC)-pain, WOMAC-stiffness and WOMAC-physical ability

All primary and secondary outcomes are measured at baseline, 7, 30, 60 and 90 days of the study.

Secondary outcome measures

1. TNF-alpha
2. IL-1-beta
3. Interleukin-6 (IL-6)
4. C-Reactive Protein (CRP)
5. Matrix Metelloproteinase-3 (MMP-3)

All primary and secondary outcomes are measured at baseline, 7, 30, 60 and 90 days of the study.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


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 score greater than 7 points after 7 days of withdrawal of usual medication
7. Ability to walk
8. Availability of the duration of the entire study period

Participant type


Age group




Target number of participants

75 (Seventy five)

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) less than 30
11. Systemic Lupus Erythematosis (SLE)

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Department of Orthopaedics
534 002

Sponsor information


Laila Impex R&D Center (India)

Sponsor details

Unit 1
Phase III
Jawahar Autonagar
+91 (0)866 254 5244

Sponsor type




Funder type


Funder name

Laila Impex R&D Center (India)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Results in

Publication citations

  1. Results

    Sengupta K, Alluri KV, Satish AR, Mishra S, Golakoti T, Sarma KV, Dey D, Raychaudhuri SP, A double blind, randomized, placebo controlled study of the efficacy and safety of 5-Loxin for treatment of osteoarthritis of the knee., Arthritis Res. Ther., 2008, 10, 4, R85, doi: 10.1186/ar2461.

Additional files

Editorial Notes