Condition category
Musculoskeletal Diseases
Date applied
21/11/2017
Date assigned
29/11/2017
Last edited
28/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Osteoarthritis is a condition that causes joints to become painful and stiff and most commonly affects the joints of the hip, knee, hand, foot and spine. Osteoarthritis is not only the most common musculoskeletal disorder, affecting approximately 10% of the population worldwide, but more importantly is a leading cause of pain, loss of physical function, and reduction in health-related quality of life. Non-steroidal anti-inflammatory drugs (NSAIDs) are well established as first line treatment for chronic pain in osteoarthritis, providing effective relief of symptoms in most patients. However, NSAIDs causes gastrointestinal side effects like peptic ulcers, perforations, or bleeding. Supplments such as curcumin and diclofenac could be helpful to relieve the symptoms. The aim of this study is to evaluate the efficacy and safety of curcumin, combination of curcumin and diclofenac in comparison with diclofenac alone in patients with osteoarthritis of the knee.

Who can participate?
Adults aged 38 to 65 who have osteoarthritis in at least one knee joint.

What does the study involve?
The patients are randomly allocated to one of three groups. Those in the first group receive Curcumin 500 mg thrice daily for 28 days. Those in the second group received Curcumin 500 mg plus diclofenac 50 mg twice daily for 28 days. Those in the third group receive Diclofenac 50 mg twice daily for 28 days. Participants are followed up to examine the efficacy of the medications.

What are the possible benefits and risks of participating?
Participants may benefit from improvements in their symptoms. Participation in the study is voluntary and no risk is associated with it. Patients can refuse to participate or withdraw at any time without it affecting their treatment. All information obtained for this study is used for research purposes only and will be kept strictly confidential.

Where is the study run from?
City Care Accident Hospital, ParliVaijanth (India)

When is the study starting and how long is it expected to run for?
July 2010 to January 2013

Who is funding the study?
City Care Accident Hospital, ParliVaijanth (India)

Who is the main contact?
Mr. D M Shep
dhaneshshep@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr D. M. Shep

ORCID ID

Contact details

Krishna Institute of Medical Sciences University
Pune - Bangalore Highway
Dist.Satara
Agashivnagar
Malkapur
413512
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CT240910 Version 2

Study information

Scientific title

A randomized, single-blind, comparative, clinical study to evaluate theefficacy and safety of curcumin, combination of curcumin and diclofenac in comparison with diclofenac alone in patients with osteoarthritis of the knee

Acronym

Study hypothesis

The aim of this study is evaluate the efficacy and safety of curcumin, combination of curcumin and diclofenac in comparison with diclofenac alone in patients with osteoarthritis of the knee

Ethics approval

Institutional ethics committee, Krishna Institute of Medical Sciences, 20/10/2010, ref: kimsu/PhD/11/2010

Study design

Randomised single-blind comparative clinical study

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 to request a patient information sheet

Condition

Osteoarthritis

Intervention

Participants are randomized into three groups – Group A, Group B and Group C by using a computer generated randomization sheet.
Group A: Participants receive Curcumin 500 mg thrice daily (taken orally) for 28 days.
Group B: Participants receive Curcumin 500 mg plus diclofenac 50 mg twice daily (taken orally) for 28 days
Group C: Participant receive Diclofenac 50 mg twice daily (taken orally)for 28 days.

At the time of enrollment, study & rescue medications were dispensed to the enrolled patients as per randomization. Patients are told to keep the record as per instructions and were told to come for two follow up visits (at the end of 2nd week and at the end of 4th week).

Intervention type

Phase

Drug names

Primary outcome measures

1. Efficacy of curcumin in comparison with diclofenac in the management of osteoarthritis of the knee is measured using Visual analogue scale and KOOS (Knee injury and Osteoarthritis Outcome Score) at day 14 and day 28
2. Efficacy of combination of curcumin & diclofenac in comparison with diclofenac alone in the management of osteoarthritis of the knee is measured usingVisual analogue scale and KOOS (Knee injury and Osteoarthritis Outcome Score) at day 14 and day 28

Secondary outcome measures

1. Anti-ulcer effect of curcumin is measured by counting number of H2 blockers consumed by Curcumin and Diclofenac group at day 28
2. Effect of curcumin on protection against diclofenac induced GI side effects is measured by comparing GI Side effects between Group B received Curcumin 500 mg Capsule plus diclofenac 50 mg Tab andGroup C received Diclofenac 50 mg Tab at Day 28
3. Antiflatulent effect of curcumin by measuringchange in number of episodes of flatulence from baseline at day 14
4. Safety of curcumin/diclofenac by measuringside effects at day 14 and day 28
5. Safety of combination of curcumin and diclofenac by measuring side effects at day 14 and day 28

Overall trial start date

12/07/2010

Overall trial end date

15/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subjects of both sexes between 38 and 65 years of age
2. OA in at least one knee joint (ACR classification for knee OA) confirmed by X ray
3. A minimum pain VAS score > 4 on walking in one or both knees during the 24 hours preceding recruitment
4. Duration – minimum 3 months to 2 years with no joint deformities
5. Patient ambulant and requiring treatment with anti- inflammatory drugs
6. Patient willing to give washout period of 3-7 days
7. Patient willing to give written informed consent and willing to comply with the trial protocol
8. Patients with knee osteoarthritis.

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

210

Participant exclusion criteria

There is no exclusion criteria.

Recruitment start date

27/02/2011

Recruitment end date

11/11/2012

Locations

Countries of recruitment

India

Trial participating centre

City Care Accident Hospital
ParliVaijanth
431515
India

Sponsor information

Organisation

City Care Accident Hospital

Sponsor details

City Care Accident Hospital
Maniknagar
ParliVaijanth
431515
India

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

City Care Accident Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the results in a high-impact peer-reviewed journal. First publication expected to be submitted before January 2018. Study protocol available on request.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from D M Shep dhaneshshep@gmail.com

Intention to publish date

31/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes