Combination of Curcumin and Berberine Therapy in the Treatment of Post Acute Diverticulitis (SUDD) (NCT05596214) | Clinical Trial Compass
UnknownPhase 2
Combination of Curcumin and Berberine Therapy in the Treatment of Post Acute Diverticulitis (SUDD)
Israel40 participantsStarted 2022-08-14
Plain-language summary
Curcumin (Cur), an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been extensively studied in the context of inflammatory diseases. Studies have demonstrated its efficacy in reducing chemically induced colitis in animal models and in humans.
Berberine is a phytochemical derived from plants such as coptis chinensis, goldenseal and scutellaria. These herbal remedies have been used in both Chinese and European medicine for centuries to treat digestive inflammation and infectious diseases.
Therefore the investigator see a possible dual mechanism of curcumin-Berberine (Coptis) treatment in SUDD patients through both direct anti-inflammatory action and modulation of intestinal microbiome.
This data provides basis for investigating an integrative approach to optimize and offer treatment to patients suffering from post AD SUDD. The investigator speculate that using a combined gut-directed formulation of curcumin-Berberine could benefit this subgroup of patients and improve their clinical symptoms.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Established diagnosis of previous acute diverticulitis (AD) and on-going abdominal symptoms comprising a SUDD (left abdominal pain and/or change in bowel habits and bloating)
✓. Having an active SUDD defined by Diverticular Clinical Score (DICS) score ≥10.
✓. Age 18-80 years.
✓. Able and willing to give written consent
Exclusion criteria
✕. Patient with non-controlled renal or liver disease, hypertension, cardiovascular disease, cerebrovascular disease, chronic pancreatitis, diabetes mellitus, gallstone disease, uncontrolled migraines or neurological disorders
✕. Patients with significant laboratory abnormalities, including anemia with hemoglobin \<10, leucopenia (WBC\<4k/mcl), thrombocytopenia (Plt\<100K/mcl), abnormal coagulation tests (INR, PTT), or elevation of liver or kidney function tests above the normal values.
✕. Patient with active infection, sepsis or pneumonia.
✕. Pregnant or nursing women.
What they're measuring
1
Percentage of patients reaching clinical response after initiation of therapy.