Comparing turmeric and Indian frankincense extract with pain-relieving drugs for the treatment of osteoarthritis pain

ISRCTN ISRCTN17494237
DOI https://doi.org/10.1186/ISRCTN17494237
Secondary identifying numbers 2019/PZ/01
Submission date
15/07/2019
Registration date
24/07/2019
Last edited
09/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Contact information

Dr Rizaldy Taslim Pinzon
Scientific

Bethesda Hospital
Jl Sudirman 70
Yogyakarta
55582
Indonesia

ORCiD logoORCID ID 0000-0002-3357-9907
Phone +6281294638229
Email drpinzon17@gmail.com

Study information

Study designRandomized open-label clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available.
Scientific titleThe benefit and safety of Curcuma longa and Boswellia serrata for osteoarthritis pain
Study acronymBiocurpain
Study hypothesisThe 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(s)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
ConditionOsteoarthritis
InterventionThis 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 typeSupplement
Primary outcome measurePain measured using a visual analogue scale (VAS) at baseline, 2 weeks and 4 weeks
Secondary outcome measuresPhysicians’ satisfaction with medication measured using the Physician Global Assessment (PGA) at 2 and 4 weeks
Overall study start date10/10/2018
Overall study end date01/08/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Total final enrolment105
Participant inclusion criteria1. Aged 18 years or over
2. Diagnosed with osteoarthritis of the knee (Kellgren-Lawrence grade II or III) for at least 4 weeks
Participant exclusion criteria1. 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 date01/03/2019
Recruitment end date01/07/2019

Locations

Countries of recruitment

  • Indonesia

Study participating centre

Bethesda Hospital Yogyakarta
Jl Sudirman 70
Yogyakarta
55582
Indonesia

Sponsor information

Duta Wacana Christian University School of Medicine
University/education

Dr. Wahidin Sudirohusodo 5-25
Yogyakarta
55224
Indonesia

Phone 0274-563929
Email kedokteran@staff.ukdw.ac.id
Website https://www.ukdw.ac.id/en/academic/faculty-of-medicine/
ROR logo "ROR" https://ror.org/036agwg70

Funders

Funder type

University/education

Duta Wacana Christian University School of Medicine

No information available

Results and Publications

Intention to publish date10/07/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPublication in a peer-review journal.
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/11/2019 09/09/2021 Yes No

Editorial Notes

09/09/2021: Publication reference added.
23/01/2020: Internal review.
22/07/2019: Trial's existence confirmed by ethical committee of Duta Wacana Christian University.