| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN01562001 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0020180355 |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: Osteoarthritis of the knee |
| Study hypothesis | To evaluate the role of aloe vera with or without glucosamine and Chondroitin in patients with symptomatic osteoarthritis of knees. |
| Design/methodology | Randomised, Double Blind, Placebo Controlled Trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/04/2006 |
| Anticipated end date | 30/04/2008 |
| Status of trial | Ongoing |
| Target number of participants | Not provided at time of registration |
| Interventions | Randomised, Double Blind, Placebo Controlled Trial |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | Barking, Havering and Redbridge Hospitals NHS Trust
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof Kuntal Chakravarty |
| Contact details | Consultant Rheumatologist
Rheumatology Dept
Harold Wood Hospital
Gubbins Lane
Romford
United Kingdom
RM3 0BE |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN01562001 |
| Date last extracted from ISRCTN register | 17/04/2008 |
