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 |
| Protocol serial number | 08-002/5-Loxin+/OA |
| Sponsor | Laila Impex (India) |
| Funder | Laila Impex (India) |
- 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
Scientific
Department of Orthopaedics
ASR Academy of Medical Sciences
Eluru
534 002
India
| Phone | +91 8812 249361 |
|---|---|
| asramed@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 5-Loxin®, 5-Loxin® BSO |
| Primary outcome measure(s) | 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. |
| Key secondary outcome measure(s) | 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. |
| Completion date | 14/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
534 002
India
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
