Condition category
Musculoskeletal Diseases
Date applied
15/07/2019
Date assigned
24/07/2019
Last edited
24/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://www.ukdw.ac.id/en/academic/faculty-of-medicine/

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

Publication citations

Additional files

Editorial Notes

22/07/2019: Trial's existence confirmed by ethical committee of Duta Wacana Christian University.