Evaluating Effects of Curcumin in Moderate to Severe Asthmatics

Loma Linda University (LLU)

Status and phase: Withdrawn; Phase 2

Conditions: Asthma

Treatments: Other: Placebo; Drug: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT04353310

145101 (Other Identifier)

5190424

Details and patient eligibility

About

The purpose of this investigator-initiated study is to evaluate the effects of oral curcumin supplementation versus placebo in adult patients with moderate to severe asthma. Curcumin, a derivative of turmeric, has been shown in animal models to inhibit the secretion of pro-inflammatory cytokines and decrease airway constriction and hyperreactivity with only a few observational studies available in humans with discordant results.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged 18 and older

4. Physician diagnosed moderate to severe asthma: (GINA 2018)

   a. Stable asthma that requires ICS/LABA and/or an additional controller agent (i.e. LTRA, LAMA)

5. Ability to take oral medication and be willing to adhere to the regimen

6. Ability to speak and read English

7. If female and sexually active, should use effective forms of birth control

Exclusion criteria

1. Current use of turmeric (curcumin) or use within the last 7 days
2. Current use of biologic therapy/ immunotherapy/ or bronchothermoplasty
3. Pregnancy or lactation
4. Known allergic reactions to components of turmeric (curcumin)
5. Current use of anticoagulants, and history of coagulopathy or liver disease
6. INR greater than 2.0, PTT greater than 45.0 seconds

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Curcumin

Experimental group

Treatment:

Drug: Curcumin

Placebo

Placebo Comparator group

Treatment:

Other: Placebo