Condition category
Musculoskeletal Diseases
Date applied
18/05/2006
Date assigned
22/06/2006
Last edited
18/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.santerra-pharma.com

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 measures

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

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

http://www.santerra-pharma.com

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/17974032

Publication citations

  1. 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.

Additional files

Editorial Notes