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A randomised, double-blind, placebo-parallel controlled clinical study of KEDALING tablets for the treatment of depressed patients with a history of coronary artery disease

A randomised, double-blind, placebo-parallel controlled clinical study of KEDALING tablets for the treatment of depressed patients with a history of coronary artery disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100128
Enrollment
Unknown
Registered
2025-04-03
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Chronic coronary syndrome with mild to moderate depression

Interventions

Test Group:Kedaling tablets in combination with conventional medication
Control Group:Kedaling simulant combined with conventional treatment

Sponsors

Affiliated hangzhou first people's hospital, zhejiang university school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.18 years old = 8 and <= 24 on the Hamilton Depression Scale (HAMD-17) items at the screening period; 5.Clearly understand, voluntarily participate in the study, and sign an informed consent form;

Exclusion criteria

Exclusion criteria: 1.After a 1-week placebo introductory period, patients had a >= 25% reduction in HAMD-17 score compared with that at screening; 2.Patients with a previous history of suicide, or currently at serious risk of suicide, or a score of >= 3 on the HAMD-17 suicidality item; those with a history of epilepsy; depressive episodes of bipolar disorder, or depressive episodes secondary to other psychiatric or somatic disorders; 3.Severe anxiety, Hamilton Anxiety Scale (HAMA) score >21; 4.Acute myocardial events, unstable angina, severe heart failure; severe cardiac arrhythmias; severe or poorly controlled hypertension (systolic >= 180mmHg or diastolic >= 110mmHg); seated blood pressure systolic 3 times the upper limit of normal, and/or blood creatinine > 2 times the upper limit of normal); 7.Those who have taken selective 5-HT reuptake inhibitors (e.g. fluoxetine) within four weeks prior to enrolment; those who have taken monoamine oxidase inhibitors (e.g. phenelzine) within two weeks prior to enrolment; and those who are currently taking and need to take anti-anxiety medication or antidepressant medication for a long period of time. 8.Pregnant or breastfeeding women, women of childbearing age who are not using effective contraception or who are planning to conceive during the test, and those who have had a positive pregnancy test before the test. 9.Participants in other clinical trials within 30 days prior to screening; 10.Other reasons the researcher felt it would be inappropriate to participate in the trial;

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale scores;

Secondary

MeasureTime frame
The Seattle Angina Scale;Routine blood tests, biochemistry, thyroid function, cortisol, C-reactive protein and interleukin;

Countries

China

Contacts

Public ContactZhong Yigang; Xie Jianchang

Affiliated hangzhou first people's hospital, zhejiang university school of medicine

xjc46@foxmail.com+86 571 5600 5600

Outcome results

None listed

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