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A Multicenter Randomized Controlled Trial of Jiangzhiling Granules in Treating Abnormal Lipid Metabolism after HAART

A Multicenter Randomized Controlled Trial of Jiangzhiling Granules in Treating Abnormal Lipid Metabolism after HAART

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052333
Enrollment
Unknown
Registered
2021-10-24
Start date
2017-08-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

HIV/AIDS lipid metabolism abnormalities

Interventions

experimental group:Jianzhi Ling granule +HAART
control group:Fenofibrate capsule +HAART

Sponsors

Guangzhou Eighth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) HIV antibody was confirmed to be positive by Western Blot; (2) treated with TNF+3TC+LPV/ R, and HIV-RNA 6.22mmol/L or TG > 2.26mmol/L in fasting for at least four weeks, and TC and TG were normal before antiviral treatment; (4) CD4 > 200 cells/mm3; (5) In line with the TCM syndrome differentiation of "phlegm and blood stasis syndrome mutual formation"; (6) Aged 18 to 65 years old male or female; (7) Voluntarily participate in this study, sign the informed consent, and follow up can be done.

Exclusion criteria

Exclusion criteria: (1) Any patient with a history of ischaemic heart disease, or who has been hospitalized for myocardial infarction and angina, with a history of heart damage from ischaemic heart disease demonstrated by electrocardiogram or ultrasound; (2) Have received other lipid-lowering therapy in the past 3 months, or are currently using hormones, thiazide diuretics, beta-blockers, steroid hormones and contraceptives (3) in addition to the HIV/AIDS in any other serious or active disease of body and mind, is considered by the researchers may affect patient care, assessment, or compliance of the research program, including any outstanding controlled clinical significance of liver, spleen, kidneys, heart, lungs, vascular, neurologic, digestive and metabolic, pathological fracture, or tumor etc (4) Patients with hypertension, cirrhosis, diabetes, gallstones, endocrine diseases and psychosis (5) Being an alcoholic or a drug addict (6) Women who are pregnant or breastfeeding, or who plan to breastfeed during pregnancy (7) BMI > 25 (8) Abnormal liver and renal function: abnormal liver function refers to abnormal bilirubin or ALT and AST greater than 1 times the normal upper limit value; abnormal renal function refers to glomerular filtration rate (EGFR)<90 or creatinine clearance rate < 70ml/min (9) CK and CK-MB are more than 2 times of the normal upper limit (10) People who are allergic to or cannot tolerate the drugs observed in this test (11) The investigator determines that the patient may be at increased risk of treatment or fail to comply with study requirements.

Design outcomes

Primary

MeasureTime frame
Blood fat;

Secondary

MeasureTime frame
Inflammatory cytokines;C-reactive protein;T lymphocyte;Carotid intima-media thickness;TCM symptoms and signs integral;blood count;liver and kidney function;

Countries

China

Contacts

Public ContactXinghua Tan

Guangzhou Eighth People's Hospital

gz8htxh@126.com+86 13500039656

Outcome results

None listed

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