Combination of Curcumin and Berberine Therapy in the Treatment of Post Acute Diverticulitis (AD) Symptomatic Uncomplicated Diverticular Disease (SUDD)

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

• \-

Locations
Other Locations
Israel
Sheba Medical Center
RECRUITING
Ramat Gan
Contact Information
Primary
Adi Lahat-Zok, MD
Adi.Lahat@sheba.health.gov.il
+97235307072
Backup
Revital Dvir
revital.dvir@sheba.health.gov.il
+97235307072
Time Frame
Start Date: 2022-08-14
Estimated Completion Date: 2025-05
Participants
Target number of participants: 40
Treatments
Experimental: Curcumin-Berberine (coptis) therapy
Cur-Berberine (Coptis) treatment will consist: 2 capsules of 500 mg Berberine (Coptis) before breakfast (a total of 1.0gr Berberine) and 3 capsules of 500mg curcumin before dinner (a total of 1.5gr curcumin).
Placebo_comparator: Placebo
2 capsules of 500 mg placebo before breakfast and 3 capsules of 500mg placebo before dinner.
Sponsors
Leads: Dr. Adi Lahat

This content was sourced from clinicaltrials.gov

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