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A multicenter, double-blind, randomized controlled trial on the effect of DLTM Formula on the progression of coronary calcification in patients with stable coronary heart disease

A multicenter, double-blind, randomized controlled trial on the effect of DLTM Formula on the progression of coronary calcification in patients with stable coronary heart disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000060
Enrollment
Unknown
Registered
2024-05-11
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-29

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

Conditions

coronary heart disease,coronary calcification

Interventions

Group 1:DLTM Formula
Group 2:placebo

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients definitively diagnosed with coronary heart disease or confirmed by coronary angiography or coronary CT to have coronary artery stenosis =50%, and meet the criteria for stable coronary artery disease; 2) Age between 18 to 75 years, gender unrestricted; 3) Have undergone a 64-slice coronary CT angiography (CTA) within the last 3 months, with the results showing a coronary calcification score between 100 and 2000; 4) Patients voluntarily participate in this trial and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with other serious cardiac diseases or acute cerebrovascular diseases; 2) Patients with acute or chronic infections, liver or kidney dysfunction, coagulation disorders, thyroid dysfunction, and other severe primary diseases of the immune or hematopoietic systems; 3) Patients with psychiatric diseases or severe neuroses; 4) Participation in another clinical trial within the last month; 5) Patients who have previously undergone coronary artery interventional procedures for calcification; 6) Individuals with allergic constitutions, allergies to known components of the trial medication, or iodine allergies. 7) Pregnant women, those attempting to conceive, or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
coronary artery calcification volume score;

Secondary

MeasureTime frame
Cardiac function indicators, cardiac metabolic risk factors, inflammation-related laboratory indicators, mineral metabolism laboratory indicators, and other hematological indicators;Seattle Angina Questionnaire (SAQ) score;Traditional Chinese Medicine syndrome improvement score/blood stasis syndrome score;Changes in coronary plaque burden;coronary artery Agatston score;Vascular stiffness change;

Countries

China

Contacts

Public ContactYue Liu

Xiyuan Hospital, China Academy of Chinese Medical Sciences

liuyue@188.com13701167815

Outcome results

None listed

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