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Efficacy and safety of freeze-dried panax Notoginseng powder in the treatment of hyperlipidemia: a randomized, double-blind, placebo-controlled, multicenter exploratory clinical study

Efficacy and safety of freeze-dried panax Notoginseng powder in the treatment of hyperlipidemia: a randomized, double-blind, placebo-controlled, multicenter exploratory clinical study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076730
Enrollment
Unknown
Registered
2023-10-17
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Dyslipemia

Interventions

Experimental group:Panax notoginseng powder, orally, 3g/ time, twice/day
Combined use of placebo (Xuezhikang capsule simulator)
Control group:Xuezhikang capsule, orally, 0.6g/ time, twice/day
Combined with placebo (panax notoginseng powder simulator)

Sponsors

Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for hyperlipidemia; (2) Age 30 ~ 70 years old; (3) TCM syndrome differentiation for phlegm and blood stasis interjunction; (4) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Secondary hyperlipidemia; (2) Taking drugs that affect lipid metabolism; (3) Patients with serious primary diseases of the heart, cerebrovascular and hematopoietic systems; (4) Severe hypertension, type 1 diabetes, type 2 diabetes (after hypoglycemic drug treatment, fasting blood glucose is still = 11.0mmol /L); (5) Abnormal liver and kidney function. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)= 1.5 times the upper limit of reference value, creatinine (Cr) > the upper limit of reference value; (6) People who are allergic to the known ingredients of the drugs used in this study and are allergic to them; (7) Malignant tumors, chronic alcoholism, drug dependence or mental illness; (8) Pregnancy, lactation or recent family planning; (9) Those who are judged by the investigator to be unfit to participate in clinical trials; (10) Participants who have participated in or are participating in other clinical trials within the last 3 months; (11) Poor compliance, withdrawal in the middle, serious organ injury, acute critical illness and infectious diseases; (12) Those found not to meet the inclusion criteria after inclusion; (13) Those who did not use any experimental drug for various reasons after inclusion

Design outcomes

Primary

MeasureTime frame
Low density lipoprotein cholesterol;

Secondary

MeasureTime frame
Total cholesterol;Triglyceride;High density lipoprotein;

Countries

China

Contacts

Public ContactWangjie

Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

wangjie0103@126.com+86 10 8800 1925

Outcome results

None listed

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