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The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments.
The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Take Buyuan Zhixiao Formula granules |
|
| control group | Placebo Comparator | Take a placebos |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buyuan Zhixiao Formula | Drug | Buyuan Zhixiao Formula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | unit:% | Measured at 0, 3, 6, and 12 months respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood glucose | unit:mmol/l | Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively |
| 2-hour postprandial blood glucose | unit:mmol/l |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Ni, postgraduate | Contact | 13701253942 | 1831479145@qq.com | |
| zhige Wen, postgraduate | Contact | 15890643963 | 1831479145@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Qing Ni, postgraduate | China Academy of Chinese Medical Sciences Guang'anmen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Academy of Chinese Medical Sciences Guang'anmen Hospital | Beijin | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27500661 | Background | Nunes BP, Flores TR, Mielke GI, Thume E, Facchini LA. Multimorbidity and mortality in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2016 Nov-Dec;67:130-8. doi: 10.1016/j.archger.2016.07.008. Epub 2016 Aug 2. | |
| 30815788 | Background | Quinones AR, Markwardt S, Botoseneanu A. Diabetes-Multimorbidity Combinations and Disability Among Middle-aged and Older Adults. J Gen Intern Med. 2019 Jun;34(6):944-951. doi: 10.1007/s11606-019-04896-w. Epub 2019 Feb 27. |
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| Placebo |
| Drug |
The placebo contains 10% of the active ingredients of the Chinese medicine group |
|
| Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively |
| blood pressure | unit:mmHg | Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively |
| weight | unit:KG | Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively |
| waist circumference | unit:cm | Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively |
| BMI | unit:kg/m2 | Measured at 0, 1, 2, 3, 4, 5, 6, 9, and 12 months respectively |
| Total Cholesterol | unit:mmol/l | Measured at 0, 3, 6, and 12 months |
| Triglycerides | unit:mmol/l | Measured at 0, 3, 6, and 12 months |
| High density lipoprotein cholesterol | unit:mmol/l | Measured at 0, 3, 6, and 12 months |
| Low density lipoprotein cholesterol | unit:mmol/l | Measured at 0, 3, 6, and 12 months |
| Ankle-Brachial Index(ABI) | The normal range for the ABI is generally considered to be from 0.9 to 1.3. | Measured at 0, 3, 6, and 12 months |
| Fasting insulin | unit:pmol/L | Measured at 0, 3, 6, and 12 months |
| C-peptide | unit:pmol/L | Measured at 0, 3, 6, and 12 months |
| insulin resistance index | Measured at 0, 3, 6, and 12 months |
| islet β-cell function index | Measured at 0, 3, 6, and 12 months |
| lipid Lipid accumulation product | Measured at 0, 3, 6, and 12 months |
| visceral adiposity index | Measured at 0, 3, 6, and 12 months |
| Measurement Results of Tumor Necrosis Factor-alpha Levels at Different Time Points | Measured at 0, 3, 6, and 12 months |
| Concentration Variation of Interleukin-10 | Measured at 0, 3, 6, and 12 months |
| Change in Homocysteine Levels | Measured at 0, 3, 6, and 12 months |
| Average Concentration of Interleukin-6 | Measured at 0, 3, 6, and 12 months |
| Change in Endothelin-1 Levels | Measured at 0, 3, 6, and 12 months |
| Average Concentration of Nitric Oxide | Measured at 0, 3, 6, and 12 months |
| Concentration Variation of Von Willebrand Factor | Measured at 0, 3, 6, and 12 months |
| Measurement Results of Vascular Endothelial Growth Factor Levels at Different Time Points | Measured at 0, 3, 6, and 12 months |
| Change in Matrix Metalloproteinase-9 Levels" or "Participants' Matrix Metalloproteinase-9 Concentration | Measured at 0, 3, 6, and 12 months |
| Average Concentration of Soluble Intercellular Adhesion Molecule-1 | Measured at 0, 3, 6, and 12 months |
| Change in Serum Tau Protein Levels | Measured at 0, 3, 6, and 12 months |
| Average Concentration of Aβ40 | Measured at 0, 3, 6, and 12 months |
| Average Concentration of Aβ42 | Measured at 0, 3, 6, and 12 months |
| Change in Neurofilament Light Chain Protein Levels | Measured at 0, 3, 6, and 12 months |
| Carotid Ultrasound; Carotid Intima-Media Thickness. | Measured at 0, 6, and 12 months |
| Activities of Daily Living Scale score; Fried Frailty Phenotype Scale; Mini Nutritional Rating Scale; MoCA scale score; Traditional Chinese Medicine Kidney Deficiency and Blood Stasis Syndrome Scale score. | Measured at 0, 3, 6, and 12 months |
| Montreal Cognitive Assessment Score | The maximum score is 30 points, and the higher the score, the better the cognitive function. | Measured at 0, 3, 6, and 12 months |
| Fried Frailty Phenotype Scale | Those who have 5 or more of the items in the table can be diagnosed as frailty syndrome; those with less than 3 items are in the early stage of frailty; 0 items are healthy elderly people without frailty. | Measured at 0, 3, 6, and 12 months |
| Activities of Daily Living Scale score | The scale consists of 10 items, with a total score of 100 points. The Cronbach's alpha of the scale is 0.813. A score of 100 points is considered normal, while scores below 100 indicate a decline.A score of 100 points indicates full independence in daily living, without any dependency; 61-99 points suggest mild dependency; 41-60 points indicate moderate dependency; ≤40 points denote severe dependency. | Measured at 0, 3, 6, and 12 months |
| Mini Nutritional Rating Scale | The total score is 14 points, with the Cronbach's alpha of the scale being 0.906. A score of ≤7 points is considered malnourished, 8-11 points indicate a risk of malnutrition, and 12-14 points are indicative of normal nutrition. The total score is 14 points, with the Cronbach's alpha of the scale being 0.906. A score of ≤7 points is considered malnourished, 8-11 points indicate a risk of malnutrition, and 12-14 points are indicative of normal nutrition. | Measured at 0, 3, 6, and 12 months |
| Serum and urine metabolomics | Inferring the potential biological mechanisms of the effect of Buyuan Zhixiao Formula based on the differences in metabolic products in the blood and urine between the experimental and control groups. | Measured at 0 and 6 months respectively |
| Cangzhou integrative medicine hospital | Hebei | China |
|
| Hohhot Mongolian Traditional Chinese Medicine Hospital | Neimeng | China |
| Binzhou Traditional Chinese Medicine Hospital | Shandong | China |
|
| Yantai Baishi Traditional Chinese Medicine Hospital | Shandong | China |
| The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | China |
|
| 23810406 | Background | Ji L, Hu D, Pan C, Weng J, Huo Y, Ma C, Mu Y, Hao C, Ji Q, Ran X, Su B, Zhuo H, Fox KA, Weber M, Zhang D; CCMR Advisory Board; CCMR-3B STUDY Investigators. Primacy of the 3B approach to control risk factors for cardiovascular disease in type 2 diabetes patients. Am J Med. 2013 Oct;126(10):925.e11-22. doi: 10.1016/j.amjmed.2013.02.035. Epub 2013 Jun 27. |
| 20569763 | Background | Carnethon MR, Biggs ML, Barzilay J, Kuller LH, Mozaffarian D, Mukamal K, Smith NL, Siscovick D. Diabetes and coronary heart disease as risk factors for mortality in older adults. Am J Med. 2010 Jun;123(6):556.e1-9. doi: 10.1016/j.amjmed.2009.11.023. |
| 26257035 | Background | Al Slail FY, Abid O, Assiri AM, Memish ZA, Ali MK. Cardiovascular risk profiles of adults with type-2 diabetes treated at urban hospitals in Riyadh, Saudi Arabia. J Epidemiol Glob Health. 2016 Mar;6(1):29-36. doi: 10.1016/j.jegh.2015.07.004. Epub 2015 Aug 6. |
| 32068097 | Result | Sinclair A, Saeedi P, Kaundal A, Karuranga S, Malanda B, Williams R. Diabetes and global ageing among 65-99-year-old adults: Findings from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2020 Apr;162:108078. doi: 10.1016/j.diabres.2020.108078. Epub 2020 Feb 14. |
| 21059202 | Result | Al-Maskari F, El-Sadig M, Nagelkerke N. Assessment of the direct medical costs of diabetes mellitus and its complications in the United Arab Emirates. BMC Public Health. 2010 Nov 8;10:679. doi: 10.1186/1471-2458-10-679. |
| 32175717 | Result | Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001. |
| 26073574 | Result | Ramtahal R, Khan C, Maharaj-Khan K, Nallamothu S, Hinds A, Dhanoo A, Yeh HC, Hill-Briggs F, Lazo M. Prevalence of self-reported sleep duration and sleep habits in type 2 diabetes patients in South Trinidad. J Epidemiol Glob Health. 2015 Dec;5(4 Suppl 1):S35-43. doi: 10.1016/j.jegh.2015.05.003. Epub 2015 Jun 11. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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