Comparative efficacy of 5-Loxin® and its improved composition (5-Loxin®BSO) in the treatment of osteoarthritis of knee: a randomised, double-blind placebo-controlled clinical study

ISRCTN	ISRCTN80793440
DOI	https://doi.org/10.1186/ISRCTN80793440
Secondary identifying numbers	08-002/5-Loxin+/OA

Submission date: 13/09/2008
Registration date: 09/10/2008
Last edited: 30/12/2020

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 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

Phone	+91 8812 249361
Email	asramed@gmail.com

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	Comparative efficacy of 5-Loxin® and its improved composition (5-Loxin®BSO) in the treatment of osteoarthritis of knee: a randomised, double-blind placebo-controlled clinical study
Study objectives	The purpose of this study is to assess the comparative efficacy of 5-Loxin® and an improved novel composition of 5-Loxin® (5-Loxin® BSO) against osteoarthritis (OA) and pain management, which represent a challenge to the health professionals. Results of a related study can be found at: http://www.ncbi.nlm.nih.gov/pubmed/18667054 (this trial is registered with ISRCTN05212803).
Ethics approval(s)	This protocol was approved by the Institutional Review Board (IRB) of Alluri Sitarama Raju Academy of Medical Sciences (ASRAM) on the 16th July 2008.
Health condition(s) or problem(s) studied	Osteoarthritis of knee
Intervention	60 subjects randomised into 3 groups (n = 20): 1. 5-Loxin® (oral) 50 mg twice daily (bid) 2. 5-Loxin®-BSO (oral) 50 mg bid 3. Placebo Ibuprofen will be used as a rescue medication for all groups. The study duration is 90 days and evaluations will be at baseline, 7, 30, 60 and 90 days.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	5-Loxin®, 5-Loxin® BSO
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 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) 2. 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 date	15/09/2008
Completion date	14/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Total final enrolment	60
Key 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
Key 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
Date of first enrolment	15/09/2008
Date of final enrolment	14/12/2008

Locations

Countries of recruitment

India

Study participating centre

Department of Orthopaedics

Eluru
534 002
India

Sponsor information

Laila Impex (India)
Industry

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

Phone	+91 866 254 5244
Email	lailarescen@sify.com
Website	http://lailaimpex.tradeindia.com
"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 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	01/11/2010	30/12/2020	Yes	No

Editorial Notes

30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.