Health TrialsbyHealthPanel

RCT for the Chinese Medicine in Treating Hypercholesterolemia

ConditionHypercholesterolemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChinese University of Hong Kong

About this trial

This is a randomized, double-blind, placebo-controlled clinical trial. Eligible subjects will randomized into a treatment group or placebo group. They will receive either Chinese medicine granules or placebo granules for 8 weeks followed by a 4-week observation period. The primary outcome would be the percent change in Low-density lipoprotein cholesterol levels (LDL-C) after treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years old, any gender;

LDL-C level of 4.1 mmol/L or above (no statin therapy during the screening period);

Be able to maintain a more consistent lifestyle and eating habits throughout the study;

Have a fixed residence and are not expected to move or travel for 8 weeks;

Disqualifiers

Taking drugs that may affect lipid metabolism (such as steroids, sleeping pills, and psychotropic drugs);

Alcohol or drug abuse within the last 3 months;

Known liver function or renal dysfunction;

History of severe cardiovascular and cerebrovascular diseases; or history of psychiatric illness;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dachaihu Decoction combined Erzhiwan with variation

    Drug

    Chinese medicine granules

  • Placebo granules

    Other intervention

    Placebo granules

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Dachaihu Decoction combined Erzhiwan with variation granulesExperimental treatment 1 intervention
Group B: Placebo granulesPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels

Compare the percent change in LDL-C levels from baseline to week 8

Time frame
8 weeks

Secondary outcomes

1

The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels

Compare the percent change in LDL-C levels from baseline to week 4

Time frame
4 weeks
2

The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels

Compare the percent change in LDL-C levels from baseline to week 12

Time frame
12 weeks
3

The level of Low-density lipoprotein-cholesterol (LDL-C)

The level of LDL-C at week 4

Time frame
4 weeks
4

The level of Low-density lipoprotein-cholesterol (LDL-C)

The level of LDL-C at week 8

Time frame
8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: