The Effects of Allicor on Patients After Coronary Arteria Revascularization Treatment
NCT ID: NCT05803759
Last Updated: 2023-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2023-04-10
2025-03-31
Brief Summary
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The purpose of this study is to determine whether the intake of dietary supplement Allicor at a daily dose of 300 mg affects the frequency of long-term postoperative cardiovascular complications and re-intervention in patients after revascularization operations on the coronary arteries. The second goal is assessing the relationship between the grade monocytes inflammatory response and the level of heteroplasmy of the mitochondrial genome of blood leukocytes with the frequency of cardiovascular complications and re-interventions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Allicor
Dietary Supplement: Allicor 150 mg capsule by mouth two times a day
Allicor
Each capsule contains 150 mg dried garlic powder
Placebo
Placebo capsule manufactured to mimic Allicor 150 mg capsule by by mouth two times a day
Placebo
Capsules manufactured to mimic Allicor 150 mg capsules
Interventions
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Allicor
Each capsule contains 150 mg dried garlic powder
Placebo
Capsules manufactured to mimic Allicor 150 mg capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with coronary arteries atherosclerosis for whom coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) is indicated
3. Patients passed a complex of instrumental and laboratory examinations before revascularization, including ECG, echocardiography, visualization of coronary vessels by X-ray contrast angiography, or CT, screening for atherosclerotic lesions of large arteries, including common carotid arteries, abdominal segment of the aorta, arteries of the lower extremities, biochemical analysis of blood included assessment of cholesterol, triglycerides, low density lipoproteins, high density lipoproteins and glucose levels.
4. The possibility of monitoring the patient for 12 months after revascularization, including phone contacts and visits to the clinic after 6 and 12 months.
5. Patient or legal authorized representative capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria
2. Critical and urgent cardiovascular conditions: tissue ischemia stage III-IV, stroke, acute coronary syndrome, myocardial infarction, chronic heart failure III and IV class NYHA (New York Heart Association).
3. Other critical and urgent conditions not associated with cardiovascular diseases, including the need for urgent interventions, chronic renal failure stages IV-V (creatinine clearance \< 30 ml / min according to the Cockcroft-Gault Equation)
4. High degree of disability of the patient (4 or higher points on the modified Rankin scale).
5. History of systemic autoimmune diseases.
6. Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology.
7. Conditions that limit adherence to participation in the study (dementia, neuropsychiatric diseases, drug addiction, alcoholism, etc.).
8. Participation in other clinical studies (or use of investigational substances) within 3 months prior to study entry.
9. Patients with malignant tumors, including the postoperative period with chemotherapy and / or radiation therapy.
10. Carriers of HIV or viral hepatitis
11. Pregnancy or breast feeding
12. Refusal to participate in the study.
40 Years
75 Years
ALL
No
Sponsors
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Institute for Atherosclerosis Research, Russia
OTHER
Responsible Party
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Locations
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Institute for Atherosclerosis Research
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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References
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Falk E. Pathogenesis of atherosclerosis. J Am Coll Cardiol. 2006 Apr 18;47(8 Suppl):C7-12. doi: 10.1016/j.jacc.2005.09.068.
Bradley JM, Organ CL, Lefer DJ. Garlic-Derived Organic Polysulfides and Myocardial Protection. J Nutr. 2016 Feb;146(2):403S-409S. doi: 10.3945/jn.114.208066. Epub 2016 Jan 13.
Orekhov AN, Tertov VV. In vitro effect of garlic powder extract on lipid content in normal and atherosclerotic human aortic cells. Lipids. 1997 Oct;32(10):1055-60. doi: 10.1007/s11745-997-0136-7.
Orekhov AN, Grunwald J. Effects of garlic on atherosclerosis. Nutrition. 1997 Jul-Aug;13(7-8):656-63. doi: 10.1016/s0899-9007(97)83010-9.
Imaizumi VM, Laurindo LF, Manzan B, Guiguer EL, Oshiiwa M, Otoboni AMMB, Araujo AC, Tofano RJ, Barbalho SM. Garlic: A systematic review of the effects on cardiovascular diseases. Crit Rev Food Sci Nutr. 2023;63(24):6797-6819. doi: 10.1080/10408398.2022.2043821. Epub 2022 Feb 23.
Mollahosseini M, Hosseini-Marnani E, Panjeshahin A, Panbehkar-Jouybari M, Gheflati A, Mozaffari-Khosravi H. A systematic review of randomized controlled trials related to the effects of garlic supplementation on platelet aggregation. Phytother Res. 2022 Nov;36(11):4041-4050. doi: 10.1002/ptr.7556. Epub 2022 Oct 12.
Panyod S, Wu WK, Chen PC, Chong KV, Yang YT, Chuang HL, Chen CC, Chen RA, Liu PY, Chung CH, Huang HS, Lin AY, Shen TD, Yang KC, Huang TF, Hsu CC, Ho CT, Kao HL, Orekhov AN, Wu MS, Sheen LY. Atherosclerosis amelioration by allicin in raw garlic through gut microbiota and trimethylamine-N-oxide modulation. NPJ Biofilms Microbiomes. 2022 Jan 27;8(1):4. doi: 10.1038/s41522-022-00266-3.
Reinhart KM, Talati R, White CM, Coleman CI. The impact of garlic on lipid parameters: a systematic review and meta-analysis. Nutr Res Rev. 2009 Jun;22(1):39-48. doi: 10.1017/S0954422409350003.
Orekhov AN, Sobenin IA, Korneev NV, Kirichenko TV, Myasoedova VA, Melnichenko AA, Balcells M, Edelman ER, Bobryshev YV. Anti-atherosclerotic therapy based on botanicals. Recent Pat Cardiovasc Drug Discov. 2013 Apr;8(1):56-66. doi: 10.2174/18722083113079990008.
Sobenin IA, Pryanishnikov VV, Kunnova LM, Rabinovich YA, Martirosyan DM, Orekhov AN. The effects of time-released garlic powder tablets on multifunctional cardiovascular risk in patients with coronary artery disease. Lipids Health Dis. 2010 Oct 19;9:119. doi: 10.1186/1476-511X-9-119.
Wlosinska M, Nilsson AC, Hlebowicz J, Hauggaard A, Kjellin M, Fakhro M, Lindstedt S. The effect of aged garlic extract on the atherosclerotic process - a randomized double-blind placebo-controlled trial. BMC Complement Med Ther. 2020 Apr 29;20(1):132. doi: 10.1186/s12906-020-02932-5.
Lindstedt S, Wlosinska M, Nilsson AC, Hlebowicz J, Fakhro M, Sheikh R. Successful improved peripheral tissue perfusion was seen in patients with atherosclerosis after 12 months of treatment with aged garlic extract. Int Wound J. 2021 Oct;18(5):681-691. doi: 10.1111/iwj.13570. Epub 2021 Feb 16.
Hamal S, Cherukuri L, Birudaraju D, Matsumoto S, Kinninger A, Chaganti BT, Flores F, Shaikh K, Roy SK, Budoff MJ. Short-term impact of aged garlic extract on endothelial function in diabetes: A randomized, double-blind, placebo-controlled trial. Exp Ther Med. 2020 Feb;19(2):1485-1489. doi: 10.3892/etm.2019.8377. Epub 2019 Dec 27.
Gao X, Xue Z, Ma Q, Guo Q, Xing L, Santhanam RK, Zhang M, Chen H. Antioxidant and antihypertensive effects of garlic protein and its hydrolysates and the related mechanism. J Food Biochem. 2020 Feb;44(2):e13126. doi: 10.1111/jfbc.13126. Epub 2019 Dec 26.
Ried K. Garlic lowers blood pressure in hypertensive subjects, improves arterial stiffness and gut microbiota: A review and meta-analysis. Exp Ther Med. 2020 Feb;19(2):1472-1478. doi: 10.3892/etm.2019.8374. Epub 2019 Dec 27.
Piragine E, Citi V, Lawson K, Calderone V, Martelli A. Potential Effects of Natural H2S-Donors in Hypertension Management. Biomolecules. 2022 Apr 14;12(4):581. doi: 10.3390/biom12040581.
Other Identifiers
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IAR-AL-CAR
Identifier Type: -
Identifier Source: org_study_id
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