Curcumin for Thumb Arthritis

Overseen By Brent DeGeorge, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Brent DeGeorge

Must not be taking: Anticoagulants, Antiplatelets, CYP substrates

Disqualifiers: Severe disease, Mental illness, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether turmeric (Curcumin) can reduce pain and improve life for people with thumb-joint arthritis. While turmeric is popular as a natural remedy for joint pain, its effect on thumb arthritis has not been studied in humans. Participants will take turmeric capsules and placebo capsules (look-alike pills with no active ingredient) and report their experiences over time. This trial may suit those who have experienced thumb-joint arthritis pain for more than 30 days. As a Phase 1 trial, this research aims to understand how turmeric works in people, offering participants the opportunity to be among the first to receive this treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, if you are taking any medications that are processed by certain liver enzymes (like CYP3A4, CYP2C19, CYP2C8, CYP2C9, CYP1A2, or CYP2B6), you must stop them at least 14 days before the study starts. Check with the trial team to see if your medications are affected.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Studies have shown that curcumin, a natural ingredient in turmeric, is generally safe. Research indicates that people with arthritis, including osteoarthritis, have tolerated curcumin well, reporting less pain and swelling without major side effects. The FDA considers curcumin safe for use in foods, and it is available over-the-counter for pain relief. This suggests curcumin is likely safe for most people considering it for thumb-joint arthritis. Always consult a healthcare provider before starting any new treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for thumb arthritis, which often include NSAIDs and corticosteroids, curcumin offers a natural alternative with a unique approach. Curcumin, derived from turmeric, is known for its anti-inflammatory properties, potentially reducing joint pain and swelling without the side effects commonly associated with synthetic medications. Researchers are excited about curcumin because it targets inflammation at its source and is taken orally, making it a non-invasive option. This natural compound could provide relief with fewer risks, appealing to those seeking a more holistic treatment path.

What evidence suggests that curcumin might be an effective treatment for thumb arthritis?

Research has shown that curcumin, a natural ingredient in turmeric, might help ease arthritis pain. In studies, curcumin improved joint function and reduced morning stiffness in people with arthritis. Some research also found that curcumin was as effective as the drug diclofenac, with 94% of curcumin users experiencing symptom relief. While these results are encouraging, they primarily focus on knee and hand arthritis, not specifically arthritis in the thumb joint. This trial will test oral curcumin for thumb arthritis pain, and positive outcomes in similar conditions suggest that curcumin might also help with thumb arthritis pain. ^{1 3 6 7 8}

Who Is on the Research Team?

Brent DeGeorge, MD, PhD

Principal Investigator

University of Virginia Department of Plastic Surgery

Are You a Good Fit for This Trial?

This trial is for adults over 18 with thumb-joint arthritis who are willing to follow the study procedures and can commit to the duration of the study. They must consent to participate and agree to use reliable birth control methods like Depo-Provera, IUDs, condoms, or sterilization.

Inclusion Criteria

I have signed a consent form for the trial.

I am willing and able to follow all study requirements.

I use an IUD for birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral curcumin or placebo capsules twice daily for 4 weeks, followed by a crossover to the other condition for another 4 weeks with a 2-week washout period in between.

10 weeks

Weekly surveys and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up visit seven days after the last dose of curcumin.

2 weeks

1 follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• Curcumin

Trial Overview The trial is testing if Turmeric (Curcumin) capsules can relieve pain or improve patient-reported outcomes better than a placebo in those with thumb-joint arthritis. Participants will take Turmeric for four weeks, then switch to a placebo for another four weeks while completing daily surveys about their condition.

How Is the Trial Designed?

Group I: Oral curcumin Experimental Treatment 1 Intervention

Oral curcumin 500 mg capsules taken twice each day for 4 weeks.

Group II: Placebo Placebo Group 1 Intervention

Oral placebo capsules taken twice each day for 4 weeks.

Curcumin is already approved in United States, European Union, India, China for the following indications:

Approved in United States as Curcumin for:

• Dietary Supplement

Approved in European Union as Curcuma for:

• Herbal Medicinal Product

Approved in India as Haldi for:

• Traditional Medicine

Approved in China as Jiang Huang for:

• Traditional Chinese Medicine

Who Is Running the Clinical Trial?

Brent DeGeorge

Lead Sponsor

Trials

2

Recruited

200+

Published Research Related to This Trial

Curcumin, the main active compound in turmeric, has demonstrated a wide range of beneficial effects, including anti-inflammatory, antioxidant, and anti-cancer properties, making it a promising treatment for various diseases.

The review highlights that curcumin has an excellent safety profile, suggesting it can be used effectively in managing conditions like arthritis, Alzheimer's, and other chronic diseases without significant risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Review on Physiological Effects of Curcumin. Ahsan, R., Arshad, M., Khushtar, M., et al.[2021]

Curcuma longa, commonly known as turmeric, is a medicinal herb with a long history of use in traditional Chinese and Ayurvedic medicine for its anti-inflammatory properties and treatment of various ailments.

Current research highlights turmeric's potential health benefits, including its antioxidant, hepatoprotective, and antimicrobial effects, making it relevant for conditions like cardiovascular disease and gastrointestinal disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcuma longa (turmeric). Monograph. [2022]

Turmeric, particularly its active component curcumin, exhibits a wide range of beneficial biological activities, including anti-inflammatory, antioxidant, and anticancer effects, making it a promising candidate for clinical research.

The review highlights the safety profile of turmeric, suggesting it has low toxicity, which supports its use as a natural treatment option for various diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemistry, Safety, Pharmacological Activities, and Clinical Applications of Turmeric: A Mechanistic Review. Ahmad, RS., Hussain, MB., Sultan, MT., et al.[2020]

Curcuma species, particularly C. longa, C. aromatica, and C. xanthorrhiza, are widely used in traditional medicine for treating various health issues, including indigestion and diabetes, due to their active compounds like curcumin.

Research from 1976 to 2008 highlights curcumin's significant anti-inflammatory, antioxidant, and potential anti-cancer properties, revealing its therapeutic mechanisms and genomic effects, which support its use in modern medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the investigation of curcuminoids. Itokawa, H., Shi, Q., Akiyama, T., et al.[2022]

Curcumin, a compound found in turmeric, has been linked to various health benefits, including antioxidant and anti-inflammatory effects, supported by over 6,000 research citations and more than 100 clinical studies.

A major challenge with curcumin is its low bioavailability, which affects how well it is absorbed and utilized in the body; this review focuses on different formulations that aim to improve its delivery and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent developments in delivery, bioavailability, absorption and metabolism of curcumin: the golden pigment from golden spice. Prasad, S., Tyagi, AK., Aggarwal, BB.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12502247/

Efficacy and safety of curcumin in patients with hand ... Based on the results of this pilot study, the authors conclude that a three-month regimen of low-dose oral curcumin may improve pain and ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT06359665

Oral Curcumin for the Treatment of Pain of Thumb Base Joint ... The goal of this clinical trial is to learn about the use of turmeric (Curcumin) as a treatment for pain of thumb-joint arthritis.

3. withpower.com withpower.com/trial/phase-1-arthritis-5-2024-4772d

Curcumin for Thumb Arthritis · Info for Participants The goal of this clinical trial is to learn about the use of turmeric (Curcumin) as a treatment for pain of thumb-joint arthritis.

4. health.harvard.edu health.harvard.edu/blog/curcumin-for-arthritis-does-it-really-work-2019111218290

Curcumin for arthritis: Does it really work? Both treatments relieved arthritis symptoms and helped to a similar degree: 94% of those taking curcumin and 97% of those taking diclofenac ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5003001/

Efficacy of Turmeric Extracts and Curcumin for Alleviating ... These results suggested that curcumin improved joint function measured by morning stiffness, movements, and other clinical assessments in comparison with the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9353077/

Efficacy and Safety of Curcumin and Curcuma longa ... Curcumin and Curcuma longa Extract showed safety in all studies and improved the severity of inflammation and pain levels in these arthritis patients.

7. fda.gov fda.gov/files/food/published/GRAS-Notice-000686---Curcumin-from-turmeric-%28Curcuma-longa-L.%29.pdf

GRAS-Notice-000686---Curcumin-from-turmeric-(Curcuma ... Safety Data on Curcumin ... Efficacy and safety of Curcuma domestica extracts in patients with knee osteoarthritis.

8. newsnetwork.mayoclinic.org newsnetwork.mayoclinic.org/discussion/mayo-clinic-q-and-a-turmeric-for-healthier-diet-pain-relief/

Mayo Clinic Q and A: Turmeric for healthier diet, pain relief Curcumin has anti-inflammatory properties, making it a potential treatment for a number of health conditions, including pain, asthma and ...