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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn about the use of turmeric (Curcumin) as a treatment for pain of thumb-joint arthritis. Turmeric is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for knee osteoarthritis, however no clinical trial has been performed to establish efficacy of curcumin in humans for thumb-joint arthritis. The main question\[s\] it aims to answer are: * Is Turmeric more effective than placebo at relieving pain for thumb-joint arthritis? A placebo is a look-alike substance that contains no active drug. * Is Turmeric more effective than placebo at improving patient-reported outcomes for CMC arthritis? * Is Turmeric safe for participants with thumb-joint arthritis? Participants will: * take 4 weeks of daily Turmeric capsules, * take 4 weeks of daily placebo capsules * answer daily surveys about how they are feeling and functioning.

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.

What data supports the effectiveness of the treatment Curcumin for thumb arthritis?

Research shows that curcumin, a key component of turmeric, can help reduce pain and improve symptoms in people with arthritis, including knee osteoarthritis. This suggests it might also be helpful for thumb arthritis. ^{1 2 3 4 5}

Is curcumin safe for human use?

Curcumin, the main component of turmeric, has been used traditionally in medicine and is considered to have an excellent safety profile. It has been studied for its anti-inflammatory, antioxidant, and other health benefits, with over one hundred clinical studies supporting its safety in humans. ^{6 7 8 9 10}

How is curcumin different from other treatments for thumb arthritis?

Curcumin, derived from turmeric, is unique because it has anti-inflammatory properties that inhibit specific enzymes (COX-2 and 5-LOX) involved in inflammation, which may help reduce arthritis symptoms. Unlike some conventional treatments, curcumin is a natural compound with a good safety profile, though its effectiveness for thumb arthritis specifically is still being studied. ^{1 11 12 13 14}

Research Team

Brent DeGeorge, MD, PhD

Principal Investigator

University of Virginia Department of Plastic Surgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Curcuma domestica extracts in patients with knee osteoarthritis. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Turmeric Extracts and Curcumin for Alleviating the Symptoms of Joint Arthritis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Curcumin and Curcuma longa Extract in the Treatment of Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trial. [2022]

4. Scotland pubmed.ncbi.nlm.nih.gov

Effect of Turmacin supplementation on joint discomfort and functional outcome among healthy participants - A randomized placebo-controlled trial. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Effect of curcumin on gene expression and protein level of methionine sulfoxide reductase A (MSRA), SOD, CAT and GPx in Freund's adjuvant inflammation-induced male rats. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

A Comprehensive Review on Physiological Effects of Curcumin. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Curcuma longa (turmeric). Monograph. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Biochemistry, Safety, Pharmacological Activities, and Clinical Applications of Turmeric: A Mechanistic Review. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Recent advances in the investigation of curcuminoids. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Recent developments in delivery, bioavailability, absorption and metabolism of curcumin: the golden pigment from golden spice. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

Anti-inflammatory effect of Curcuma longa (turmeric) on collagen-induced arthritis: an anatomico-radiological study. [2016]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Protective Effects of Curcumin Against Nephrotoxic Agents. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Double Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Curene® versus Placebo in Reducing Symptoms of Knee OA. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Biological activities of curcumin and its analogues (Congeners) made by man and Mother Nature. [2022]