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Clinical study of intervention effect of Jianxin Capsule on type 2 diabetic patients with cardiac autonomic neuropathy based on Nrf2/ARE pathway

Clinical study of intervention effect of Jianxin Capsule on type 2 diabetic patients with cardiac autonomic neuropathy based on Nrf2/ARE pathway

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074097
Enrollment
Unknown
Registered
2023-07-31
Start date
2023-07-31
Completion date
Unknown
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac autonomic neuropathy in type 2 diabetes

Interventions

control group:Addition of methylcobalamin dispersible tablets to conventional treatment
experimental group:Addition of Jianxin Capsules to conventional treatment

Sponsors

Rugao Hospital of Traditional Chinese Medicine, Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the diagnostic criteria of western medicine diabetes cardiac autonomic neuropathy and TCM syndrome differentiation criteria of phlegm and blood stasis; (2) At the time of enrollment, blood glucose control was up to standard, with blood pressure = 140/90mmHg; (3) Age range from 30 to 75 years old; (4) I have not taken any medication that interferes with the study in the past 4 weeks (such as ß Receptor blockers; (5) Volunteer and fill out an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those who do not meet the inclusion criteria; (2) There are other neurological causes, such as cervical and lumbar spondylosis, cerebral infarction, and Guillain Barre syndrome; (3) Those who have a history of refractory hypertension, angina pectoris, myocardial infarction, heart failure, acute Cerebrovascular disease, DKA and other acute and serious diseases in the past six months, as well as those with concurrent infection; (4) Pregnant and lactating women; (5) There are serious primary diseases such as cardiovascular, cerebrovascular, liver, hematopoietic system, arteriovenous diseases, or serious diseases that affect their survival, such as malignant tumors or AIDS; (6) Those who are unable to provide sufficient emotional consent due to intellectual or behavioral impairments; (7) Suspected or confirmed history of alcohol or drug abuse; (8) According to the judgment of the researcher, other lesions that reduce the likelihood of enrollment or complicate enrollment, frequent changes in the work environment, and other situations that may lead to loss of follow-up; (9) Individuals with allergic constitution or known allergies to the ingredients in this group; (10) Patients participating in clinical research on other drugs;

Design outcomes

Primary

MeasureTime frame
Heart rate variability;Nuclear factor E2 related factor 2;heme oxygenase-1;catalase;superoxide dismutase;glutathione peroxidase;

Secondary

MeasureTime frame
Glucose metabolism indicators;blood pressure;blood fat;Quantitative integration of traditional Chinese medicine symptoms;

Countries

China

Contacts

Public ContactPu Qiang

Rugao Hospital of Traditional Chinese Medicine, Jiangsu Province

philhugh1012@163.com+86 158 6277 0654

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026