A Phase 2 interventional study of Curcumin-Berberine (coptis) and Placebo in Diverticulitis, sponsored by Dr. Adi Lahat. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by Dr. Adi Lahat · Phase 2, Interventional, and Treatment
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.
The objective of the study is to investigate the efficacy and safety of gut-directed enteric-coated curcumin-Berberine (Coptis) combination therapy to induce remission in patients suffering from post AD SUDD.
Methods:
This will be a two-stage study:
Stage 1 will comprise an open label single arm exploratory study of 10 patients suffering from post AD SUDD investigating oral Cur-Berberine (Coptis) therapy for induction of clinical response.
Stage 2: If clinical response is achieved in ≥ 3 patients and no significant safety signals will emerge, the investigator will proceed to a prospective pilot randomized placebo-controlled study.
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 63 interventional studies indexed under Diverticulitis.
Browse Diverticulitis studies →This is the only study on the registry with Dr. Adi Lahat as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Exclusion Criteria:
Known allergy to either curcumin or Berberine (Coptis)
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Combination Product: Curcumin-Berberine (coptis)
2 capsules of 500 mg placebo before breakfast and 3 capsules of 500mg placebo before dinner.
Combination Product: Placebo
dietary supplement
Placebo
Percentage of patients reaching clinical response after initiation of therapy.
Clinical response is defined as a drop of ≥3 points of the DICS score.
Time frame: 8 weeks
Percentage of patients who had a clinical remission after initiation of therapy.
Clinical remission is defined as DICS score ≤ 5 within 4 weeks.
Time frame: 8 weeks
Percentage of patients who had a rapid clinical response after induction of therapy.
Clinical response is defined as a drop of ≥3 points of the DICS score
Time frame: 8 weeks
Percentage of patients who achieve normalization and/or >50% improvement of CRP and/or calprotectin levels (computed out of patients with abnormal values at baseline for these indices).
Calculation of the percentage of patients who achieve improvement of CRP
Time frame: 8 weeks
Time-to-response defined as number of days to achieve a drop of ≥3 points of the DICS score.
Within how many days the patient achieved drop of points in the DICS questionnaire
Time frame: 8 weeks
The percentage of patients in clinical remission at day 7 after induction of therapy.
Calculation of the percentage of patients achieved clinical remission at day 7
Time frame: Within 7 days
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Sep 2024, 25 months after the start.
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