A double-blind, active-controlled, randomized, parallel group multicentric study to investigate the safety, tolerability and efficacy of reparagen - a dietary supplement compared to glucosamine sulphate in patients with moderate osteoarthritis of the knee
| ISRCTN | ISRCTN25438351 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25438351 |
| Secondary identifying numbers | VL/050421/SP |
- Submission date
- 18/05/2006
- Registration date
- 22/06/2006
- Last edited
- 18/03/2008
- 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
Mr Jayesh Chaudhary
Scientific
Scientific
Vedic Lifesciences
118 Morya House
Off Link Road
Andheri (West)
Mumbai
400 053
India
| Phone | +91 (0)22 5693 9757 |
|---|---|
| jayesh@ayuherbal.com |
Study information
| Study design | Double-blind, active-controlled, randomized, parallel group multicentric study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | REPVGLUOA |
| Study objectives | That reparagen is safe and effective in patients with moderate osteoarthritis, and compared to glucosamine sulphate, reparagen has a faster onset of action with an overall greater response. |
| Ethics approval(s) | Approved by the Institutional Ethics Committee of KJ Somaiya Medical College and Hospital, Mumbai, India, submitted on 30/12/2005, approved on 08/02/2006 |
| Health condition(s) or problem(s) studied | Moderate osteoarthritis of the knee |
| Intervention | Reparagen, a combination of a cat's claw extract (Uncaria guianensis), a herbal medicine from the Amazon, and RNI 249, an extract of maca (Lepidium meyenii) a vegetable native to the Andes compared to glucosamine sulphate |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Reparagen, glucosamine sulphate |
| Primary outcome measure | 1. Pain visual analogue score 2. Modified Western Ontario and McMaster University osteoarthritis index (WOMAC) |
| Secondary outcome measures | 1. Serum insulin-like growth factor-1 (IGF-1) 2. Global assessment of therapy 3. Patient's opinion 4. Consumption of rescue medication |
| Overall study start date | 13/05/2006 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Ambulatory adult patients of either sex >20 years of age 2. Patients with moderate osteoarthritis of the knee, clinically detected and/or diagnosed as per radiological examination and American Rhematology Association (ARA) functional classification 3. ARA functional class II or III 4. Kellgren Lawrence for knee osteoarthritis grade II, grade III 5. Patient's assessment of overall pain score between 40 and 100 mm on a pain-visual analogue scale after washout period |
| Key exclusion criteria | 1. Arthritis other than osteoarthritis 2. Arthroscopy of either knee in the past year 3. Administration of intraarticular steroids within the past three months or hyaluronic acid in the last nine months 4. Known adverse responses to non-steroidal anti-inflammatory drugs (NSAIDs), suspected hypersensitivity, allergy or other contraindication to any compounds present in the study medication 5. Significant gastrointestinal (GI) diseases or previous GI upset to NSAID administration 6. Pregnant or lactating women or woman of child-bearing age not following adequate contraception 7. Evidence of severe renal, hematopoetic disease or severe cardiac insufficiency as revealed by laboratory investigations and other tests 8. Moderate to severe peripheral neuropathy or other neurological disorders 9. Unwilling or unable to come to regular follow-up studies 10. Any condition which in the opinion of the investigator does not justify patient inclusion in the study 11. Inability to give informed consent |
| Date of first enrolment | 13/05/2006 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- India
Study participating centre
Vedic Lifesciences
Mumbai
400 053
India
400 053
India
Sponsor information
Santerra Pharmaceuticals LLC (USA)
Industry
Industry
Santerra Pharmaceuticals LLC
12721 Strickland Road
Raleigh
27613
United States of America
| Phone | +1 919 847 2221 |
|---|---|
| pbobrowski@santerra-pharma.com | |
| Website | http://www.santerra-pharma.com |
Funders
Funder type
Industry
Santerra Pharmaceuticals LLC (USA) - contracted by Rainforest Nutritionals, Inc.
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 | 31/10/2007 | Yes | No |
