Condition category
Musculoskeletal Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
24/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kuntal Chakravarty

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes