Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Mr Jayesh Chaudhary
ORCID ID
Contact details
Vedic Lifesciences
118 Morya House
Off Link Road
Andheri (West)
Mumbai
400 053
India
+91 (0)22 5693 9757
jayesh@ayuherbal.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
VL/050421/SP
Study information
Scientific title
Acronym
REPVGLUOA
Study hypothesis
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
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
Study design
Double-blind, active-controlled, randomized, parallel group multicentric study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
13/05/2006
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant 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
Recruitment start date
13/05/2006
Recruitment end date
30/09/2006
Locations
Countries of recruitment
India
Trial participating centre
Vedic Lifesciences
Mumbai
400 053
India
Sponsor information
Organisation
Santerra Pharmaceuticals LLC (USA)
Sponsor details
Santerra Pharmaceuticals LLC
12721 Strickland Road
Raleigh
27613
United States of America
+1 919 847 2221
pbobrowski@santerra-pharma.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Santerra Pharmaceuticals LLC (USA) - contracted by Rainforest Nutritionals, Inc.
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/17974032
Publication citations
-
Results
Mehta K, Gala J, Bhasale S, Naik S, Modak M, Thakur H, Deo N, Miller MJ, Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial [ISRCTN25438351]., BMC Complement Altern Med, 2007, 7, 34, doi: 10.1186/1472-6882-7-34.