Effect and Tolerance of Standardized Exclusive Dry Extracts of Curcuma Longa and of Boswellia Ser… (NCT05570123) | Clinical Trial Compass
CompletedNot Applicable
Effect and Tolerance of Standardized Exclusive Dry Extracts of Curcuma Longa and of Boswellia Serrata Among People With Hand Joint Discomfort and Dysfunction
Belgium180 participantsStarted 2022-09-14
Plain-language summary
The objective of the study is to evaluate the effect and tolerance of standardized exclusive dry extracts of Curcuma longa (CURTIL03) and of Boswellia serrata (BOSTIL01) among people with hand joint discomfort and dysfunction.
The study is prospective, randomized, double-blinded, placebo-controlled with 2 parallel-groups in 200 participants. The study is multicentric and will be done by 11 investigators located in Belgium including rheumatologists, sports and rehabilitation physicians, physical therapists, or any hand articular disease specialists.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body Mass Index ≤ 35 kg/m2
* Subjects that fulfil the following American College of Rheumatology (ACR) clinical criteria :
* Hand pain, aching, or stiffness AND
* 3 or 4 of the following features:
* Hard tissue enlargement of 2 or more of 10 selected joints,
* Hard tissue enlargement of 2 or more Distal interphalangeal (DIP) joints,
* Fewer than three swollen metacarpophalangeal (MCP) joints,
* Deformity of at least 1 of 10 selected hand joints.
The 10 selected joints are the second and third Distal Interphalangeal joint (DIP), the second and third Proximal Interphalangeal joints (PIP), and the first carpometacarpal (CMC) joints of both hands.
* Pain in hands at least half of the days in the previous month and for at least 48 h prior to the inclusion/baseline visit.
* Finger pain score of 40-80 mm on a 100 mm Visual Analog Scale (VAS) on at least one hand over the last 24 hours. Subjects should respect a 24-hours wash-out period of authorized analgesic/anti-inflammatory medications (Paracetamol/oral NSAIDs) before the visit.
* Willing to use only Paracetamol and oral NSAIDS as rescue treatment to manage hand pain during the study. Others analgesics and anti-inflammatory medication (oral and topic) are not allowed during the study and a wash out period of 5 half-life depending of the molecule should be respected before study entry.
* Able to follow the instructions of the study
* Having signed an informed consent
Exclusion Criter…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes from baseline to 3 months of mean finger pain during the last 24 hours