Curcumin/Turmeric as a Treatment for Patients With Subdural Hematomas Recurrence (CACTIS)
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|ClinicalTrials.gov Identifier: NCT03845322|
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Our long-term objective is to evaluate the efficacy of curcumin (CC) in preventing a recurrence of chronic subdural hematoma (cSDH) following surgical evacuation. Recurrence is defined as an increase in total hematoma volume on the operated side compared to a post-operative day one CT scan with persistent or recurrent neurological symptoms. The investigators propose this pilot study to assess feasibility and obtain preliminary benefit assessment of the proposed therapeutic approach.
Objective 1: To determine if the use of CC treatment reduces the total hematoma cavity volume over a 6-month interval, compared to a post-subdural drain removal CT scan. This evaluation is expected to offer sufficient evidence for a larger definitive trial.
Objective 2: Study the effect of CC on interleukin-8 (IL-8)-induced disruption of endothelial permeability in vitro using human vascular endothelial cells.
Central hypothesis: CC treatment prevents the re-accumulation of cSDH, which may occur by inhibition of IL-8 and allowing resolution of the total hematoma cavity volume over six months.
|Condition or disease||Intervention/treatment||Phase|
|Hematoma, Subdural, Chronic||Drug: Curcumin Pill Drug: Placebo pills||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is an experimental study, each consented subject will be instructed that he/she will be randomized to either the placebo group or the curcumin group.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||This is a double-blinded, randomized placebo-controlled pilot study. The patients, neurosurgeons, nurses and clinical coordinators will be blinded except for the research pharmacists who will keep a key linking a code # on a bottle handed to the clinical coordinator and the patient's medical record number (MRN #). The pill bottles handed to the clinical coordinator will be identical for placebo and CC.|
|Official Title:||Clinical Action of Curcumin/Turmeric in Chronic Subdural Hematoma Recurrence|
|Actual Study Start Date :||December 18, 2018|
|Estimated Primary Completion Date :||September 28, 2020|
|Estimated Study Completion Date :||September 28, 2022|
Experimental: Curcumin pills group
24 Patient will receive Curcumin (CC) pills, within 24 hours post-operatively (as long as they are able to take oral medication). It will then be continued TID
Drug: Curcumin Pill
Curcumin (turmeric extract), over the counter supplement (1 capsule/three times a day). According to the Company, each capsule contains: 270 mg of pure curcuminoids (curcumin) and 3 mg of black pepper extract. Recommended serving size is 3 capsules per day in total, the patients will receive 810 mg of pure curcumin and 9 mg of black pepper extract (peperine/BioPerine) per day.
Placebo Comparator: Placebo group
24 Patient will receive Placebo pills, within 24 hours post-operatively (as long as they are able to take oral medication. It will then be continued TID.
Drug: Placebo pills
The placebo pill is a vegetarian cellulose capsule, with cellulose powder inside. The composition is cellulose and magnesium stearate.
- Measurements by CT of subdural hematoma volume change [ Time Frame: 6 months ]Change of the total hematoma cavity volume compared to post-subdural drain removal to volumes of less than 80 cc in post-surgical patients
- Recurrence rate of cSDH with and without CC treatment [ Time Frame: 6 months ]Change re-accumulation rate of cSDH
- Patient's neurological status [ Time Frame: 6 months ]Change rate of persistent or recurrent neurological symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845322
|Contact: Devon A Lara, BS||505.925.4392||DLara13@salud.unm.edu|
|Contact: Laila M Mohammad, MD||505.272.6094||LMoham@salud.unm.edu|
|United States, New Mexico|
|University of New Mexico Health Sciences center||Recruiting|
|Albuquerque, New Mexico, United States, 87122|
|Contact: sharareh sazesh 505-797-1237|
|Principal Investigator:||Howard Yonas, MD||UNM|