رادار التجارب AI | ||
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حالة التجربة السريرية NCT07240168 لـ التهاب القولون التقرحي هي نشط (لا يقبل مشاركين جدد). اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
CurQD as Add-On Therapy in Vedolizumab-Treated Ulcerative Colitis Patients: Retrospective Cohort Study ٤٠٠ موجه بالمؤشرات الحيوية
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07240168 هي دراسة رصدية لـالتهاب القولون التقرحي وهي نشط (لا يقبل مشاركين جدد). بدأت في ١٥ ربيع الأول ١٤٤٧ هـ مع خطة لتجنيد ٤٠٠ مشاركًا. يقودها Evinature Ltd.، ومن المتوقع اكتمالها بحلول ٧ ربيع الأول ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٩ جمادى الأولى ١٤٤٧ هـ.
الملخص
This study aims to evaluate whether adding CurQD, a nutraceutical composed of Curcumin and QingDai, improves treatment outcomes in patients with active ulcerative colitis (UC) who are already receiving Vedolizumab but still have ongoing disease activity. The study will use de-identified patient records collected through Evinature's global data platform. We will examine whether the addition of CurQD helps patients sta...عرض المزيد
وصف مفصل
Curcumin and QingDai, (Indigo, QD) are two herbal traditional medicine compounds which have been investigated for their use in mild-moderate and moderate-severe UC, respectively. A combination of Curcumin and QD (CurQD), which was developed at Sheba Medical Center to maximize clinical efficacy while reducing long-term high-dose QD exposure, has been used in clinical practice in Israel since 2015 and has gained wide a...عرض المزيد
العنوان الرسمي
Drug Retention in Vedolizumab-treated Patients With Active UC After the Addition of Adjunct CurQD: A Retrospective Cohort Study
الحالات الطبية
التهاب القولون التقرحيالمنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:معرّفات دراسة أخرى
- IIR-2024-200598
NCT معرّف
تاريخ البدء (فعلي)
2025-09-07
آخر تحديث مُنشور
2025-11-20
تاريخ الاكتمال (المقدر)
2026-08-20
عدد المشاركين المخطط لهم
٤٠٠
نوع الدراسة
رصدية
الحالة
نشط (لا يقبل مشاركين جدد)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
Cohort 1 (VDZ + CurQD) Patients with ulcerative colitis on Vedolizumab who initiated CurQD as adjunct therapy. | CurQD (Curcumin + QingDai combination) Patients received CurQD in addition to Vedolizumab |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Number of Participants Retaining Vedolizumab Treatment at Week 12 Following Addition of CurQD | Count of participants who remain on vedolizumab (VDZ) at Week 12 after initiating adjunct CurQD. Baseline clinical activity is defined as SCCAI ≥3 or PRO-2 ≥2 with rectal bleeding ≥1. Percentages will also be calculated relative to the number of participants with Week 12 data. | Week 12 |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Number of Participants Retaining Vedolizumab at Week 30 | Count of participants with ≥30 weeks of follow-up who remain on VDZ at Week 30 after starting CurQD. Percentages will also be calculated relative to the number of participants with Week 30 data. | Week 30 |
Number of Participants Retaining Vedolizumab at Week 54 | Count of participants with ≥54 weeks of follow-up who remain on VDZ at Week 54 after starting CurQD. Percentages will also be calculated relative to the number of participants with Week 54 data | Week 54 |
Number of Participants Achieving Clinical Remission at Week 12 | Clinical response is defined as SCCAI decrease ≥3, or PRO-2 decrease ≥2 with RB = 0 and SF ≤1, among participants with available baseline and follow-up values. Percentages will also be calculated relative to the number of participants with Week 12 clinical data. | Week 12 |
Number of Participants Achieving Clinical Response at Week 54 | Same response definition as above. Percentages will also be calculated relative to the number of participants with Week 54 clinical data. | Week 54 |
Number of Participants in Clinical Remission at Week 12 | Clinical remission defined as SCCAI ≤2 or PRO-2 = 0. Percentages will also be calculated relative to the number of participants with Week 12 clinical data. | Week 12 |
Number of Participants in Clinical Remission at Week 54 | Same remission definition as above. Percentages will also be calculated relative to the number of participants with Week 54 clinical data. | Week 54 |
Number of Participants Reporting Satisfaction with CurQD + Vedolizumab (VAS 1-10) | Number of participants providing a satisfaction score using a 1-10 Visual Analog Scale (VAS) after using CurQD + VDZ. Percentages will also be calculated relative to the number of participants who completed the VAS assessment. | Week 12 |
Number of Participants Achieving Fecal Calprotectin (FCP) Response | FCP response defined as ≥50% reduction from baseline among participants with baseline FCP ≥250 mcg/g and available follow-up FCP. Percentages will also be calculated relative to the number of participants with FCP measurements. | Up to Week 54 |
Number of Participants Achieving Fecal Calprotectin (FCP) Remission | FCP remission defined as FCP \<150 mcg/g among participants with baseline FCP ≥250 mcg/g, following STRIDE II and GEMINI-I guidance. Percentages will also be calculated relative to the number of participants with FCP measurements. | Up to Week 54 |
Number of Participants Experiencing Treatment-Emergent Adverse Events | Number and type of adverse events occurring during combined CurQD + VDZ therapy. Percentages will also be calculated relative to the number of participants exposed to both therapies. | Baseline through Week 54 |
Sensitivity Analysis: Number of Participants Retaining Vedolizumab at Week 12 with Baseline SCCAI ≥6 | Same definition as the primary endpoint but limited to participants with moderate-severe disease (baseline SCCAI ≥6). Percentages will also be calculated relative to the number of participants in this subgroup with Week 12 data. | Week 12 |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
طفل, بالغ, كبار السن
العمر الأدنى للدراسة
8 Years
الجنس المؤهل
الكل
- Age >8 years
- Diagnosis of ulcerative colitis (self-reported)
- Completed Evinature clinical assessment between April 1, 2022, and cutoff date
- Vedolizumab treatment at baseline
- Active disease at entry (SCCAI ≥3 or PRO-2 ≥2 with RB ≥1)
- Initiated CurQD at entry
- Vedolizumab for indications other than UC
- Unclear medication status at baseline
- Not active disease when starting CurQD
Evinature Ltd.- مركز شيبا الطبي
- تاكيدا الدوائية210 تجارب سريرية نشطة للاستكشاف
لا توجد بيانات اتصال.
1 مواقع الدراسة في 1 بلدان
Evinature, Binyamina, Israel