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
| ISRCTN | ISRCTN01562001 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01562001 |
| Protocol serial number | N0020180355 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Barking, Havering and Redbridge Hospitals NHS Trust (UK) |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 24/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Kuntal Chakravarty
Scientific
Scientific
Consultant Rheumatologist
Rheumatology Department
Harold Wood Hospital
Gubbins Lane
Romford
RM3 0BE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | To evaluate the role of aloe vera with or without glucosamine and Chondroitin in patients with symptomatic osteoarthritis of knees. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Osteoarthritis of the knee |
| Intervention | Aloe vera with or without glucosamine and Chondroitin |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Aloe vera with or without glucosamine and Chondroitin |
| 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 |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 30/04/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Harold Wood Hospital
Romford
RM3 0BE
United Kingdom
RM3 0BE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |