Plain English Summary
Background and study aims
Osteoarthritis is a long-lasting disease that results from the inflammation of the joints, causing breakdown of the cartilage and bone. Typically, a combination of exercise, lifestyle changes and non-steroidal anti-inflammatory (NSAID) drugs are used to reduce the pain and stiffness of osteoarthritis. NSAIDs can have side effects. Curcumin is a substance found in turmeric (Curcuma longa) that has been used to treat diseases involving inflammation in Ayurvedic (traditional Indian) and traditional Chinese medicine. Indian frankincense (Boswellia serrata) is another herb used to treat inflammation in Ayurvedic medicine. This study aims to investigate whether Biocurpain, a combination of turmeric and Indian frankincense extracts, can reduce pain in people with osteoarthritis.
Who can participate?
Adults who have been diagnosed with knee osteoarthritis for at least 4 weeks.
What does the study involve?
Participants will be randomly allocated to one of three groups. The first group will take Biocurpain and NSAID ibuprofen or diclofenac by mouth twice daily for 4 weeks. The second group will take Biocurpain by mouth twice daily for 4 weeks. The third group will take ibuprofen or diclofenac by mouth twice daily for 4 weeks. Before the start of the trial, at 2 weeks and at 4 weeks, the participants will rate their pain level on a scale of 1 to 10.
What are the possible benefits and risks of participating?
The potential benefits are that the participants might experience quicker relief from pain caused by osteoarthritis. The potential risks are that the participant might experience side effects from the study medication.
Where is the study run from?
Bethesda Hospital and Panti Rapih Hospital, Yogyakarta (Indonesia)
When is the study starting and how long is it expected to run for?
Who is funding the study?
Duta Wacana Chrsitian University School of Medicine (Indonesia)
Who is the main contact?
Dr. Rizaldy Taslim Pinzon, drpinzon17@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Rizaldy Taslim Pinzon
ORCID ID
http://orcid.org/0000-0002-3357-9907
Contact details
Bethesda Hospital
Jl Sudirman 70
Yogyakarta
55582
Indonesia
+6281294638229
drpinzon17@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2019/PZ/01
Study information
Scientific title
The benefit and safety of Curcuma longa and Boswellia serrata for osteoarthritis pain
Acronym
Biocurpain
Study hypothesis
The combination of Curcuma longa and Boswellia serrata is as effective as NSAID treatment (ibuprofen or diclofenac) in treating arthritic pain with better safety profile.
Ethics approval
Approved 17/12/2018, Duta Wacana Christian University School of Medicine Ethical Research Committee, (Dr. Wahidin Sudirohusodo 5, 25 Yogyakarta, Indonesia 55224; 0274-563929 Ext. 124; kedokteranukdw@yahoo.com), ref: 867/C16/FK/2018
Study design
Randomized open-label clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available.
Condition
Osteoarthritis
Intervention
This was a randomized controlled trial study for 4 weeks. Subjects were divided into 3 groups randomly:
1. Group I: combination of CB extract (Biocurpain; 350 mg of Curcuma longa and 150 mg Boswellia serrata) and NSAID (400 mg of ibuprofen or 50 mg of diclofenac sodium)
2. Group II: CB extract alone
3. Group III: NSAID alone.
Each medication was taken two times per day for 4 weeks.Twenty tablets of 500 mg paracetamol, as a rescue medication, was given to each subject and the remaining was counted at the last week. The degree of pain measured using visual analogue scale (VAS). Physician Global Assessment (PGA) was an instrument to measure the physicians’ satisfaction with medication. Any adverse event was monitored. The analysis is intention to treat based.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Pain measured using a visual analogue scale (VAS) at baseline, 2 weeks and 4 weeks
Secondary outcome measures
Physicians’ satisfaction with medication measured using the Physician Global Assessment (PGA) at 2 and 4 weeks
Overall trial start date
10/10/2018
Overall trial end date
01/08/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or over
2. Diagnosed with osteoarthritis of the knee (Kellgren-Lawrence grade II or III) for at least 4 weeks
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Total final enrolment
105
Participant exclusion criteria
1. Not willing to join the study.
2. Subjects with known hypersensitivity to biocurpain ingredients and/or ibuprofen, diclofenac sodium or paracetamol
3. Participation in other clinical trial for the last 1 month
4. Significant renal, hepatic, gastrointestinal, and cardiovascular comorbidities
5. Pregnant or trying to become pregnant
6. Incompetent to give consent and answer the questionnaire
7. Received other pain treatment in 24 h before the study start
Recruitment start date
01/03/2019
Recruitment end date
01/07/2019
Locations
Countries of recruitment
Indonesia
Trial participating centre
Bethesda Hospital Yogyakarta
Jl Sudirman 70
Yogyakarta
55582
Indonesia
Sponsor information
Organisation
Duta Wacana Chrsitian University School of Medicine
Sponsor details
Dr. Wahidin Sudirohusodo 5-25
Yogyakarta
55224
Indonesia
0274-563929
kedokteran@staff.ukdw.ac.id
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Duta Wacana Christian University School of Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication in a peer-review journal.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
10/07/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list