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
Secondary identifying numbers	N0020180355

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

Prof Kuntal Chakravarty
Scientific

Consultant Rheumatologist
Rheumatology Department
Harold Wood Hospital
Gubbins Lane
Romford
RM3 0BE
United Kingdom

Study design	Randomised double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/04/2006
Completion date	30/04/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Not provided at time of registration
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

Harold Wood Hospital

Romford
RM3 0BE
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Barking, Havering and Redbridge Hospitals NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan