Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0020180355
Study information
Scientific title
A Prospective, Randomised, Double-blind, Placebo Controlled Study to assess the Role of Aloe Vera with or without Glucosamine & Chondroitin in Patients with Symptomatic Osteoarthritis of Knees
Acronym
Study hypothesis
To evaluate the role of aloe vera with or without glucosamine and Chondroitin in patients with symptomatic osteoarthritis of knees.
Ethics approval
Not provided at time of registration
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Musculoskeletal Diseases: Osteoarthritis of the knee
Intervention
Aloe vera with or without glucosamine and Chondroitin
Intervention type
Drug
Phase
Not Applicable
Drug names
Aloe vera with or without glucosamine and Chondroitin
Primary outcome measure
1. Assessment and comparison of overall symptoms including pain, range of motions and variables such as swelling etc in the affected joints and other measures of functional aspects of the joint
2. Assessment of Quality of life
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2006
Overall trial end date
30/04/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 18 - 80 years
2. Symptoms of episodic or continuous pain in the affected knee joint for 6 weeks
3. Diagnosis of OA of Knee made according to ACR criteria (knee pain and radiographic osteophytes and at least any one of the following 3 items: a) Age > 50 years b) Morning Stiffness < 30 minutes in duration c) Crepitus on motion
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Any contra indication to Aloe Vera /Glucosamine/Chondroitin
2. Current Use or use within 3 months of screening of aloe vera/Glucosamine/Chondroitin
3. Current or Previous history of oral steroid or injection in the study joint within 3 months
4.Current or previous history of Intra articular Synvisc or Hyalgan therapy
5. Previous history of NSAID topical application within the last 3 months
6. Any previous history of Knee surgery including Menisectomy / patellectomy etc
7. Presence of Inflammatory Arthritis
8. Presence of significant hip disease on the side of symptomatic knee
Recruitment start date
01/04/2006
Recruitment end date
30/04/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Harold Wood Hospital
Romford
RM3 0BE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barking, Havering and Redbridge Hospitals NHS Trust (UK)
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