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Phase IV clinical study on the safety and effectiveness of Sanqi Longxuejie Capsules in the treatment of coronary heart disease with stable exertional angina pectoris (Grade I, II)

Phase IV clinical study on the safety and effectiveness of Sanqi Longxuejie Capsules in the treatment of coronary heart disease with stable exertional angina pectoris (Grade I, II)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005341
Enrollment
Unknown
Registered
2021-11-27
Start date
2021-11-24
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

coronary heart disease with stable exertional angina pectoris (Grade I, II)

Interventions

Sponsors

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Adult patients 18 years of age = age = 75 years of age, regardless of gender; (2) Meet the diagnostic criteria of western medicine for stable labor-induced angina pectoris (refer to the 2018 "Guidelines for the Diagnosis and Treatment of Stable Coronary Heart Disease"); (3) Angina pectoris is classified into grades ? and ?: grade ?: general physical activity (such as walking and climbing stairs) is not restricted, but angina pectoris occurs during strong, rapid or continuous exertion; grade ?: general physical activity is slightly restricted. Angina pectoris occurs within a few hours after walking fast, after a meal, cold or windy, mentally stressed, or within a few hours after waking up. Under normal circumstances, walking on flat ground for more than 200m or for climbing buildings above one floor is restricted; (4) TCM syndromes conform to the heart and blood stasis syndrome: ? Fixed chest pain (4 points); ? Dark purple tongue or petechiae on the tongue (4 points); ? Purple sublingual vein (3 points); ? Dark purple complexion (3 points); ? petechiae or ecchymosis on the body (3 points); ? numbness of limbs (3 points); ? dark purple or dark red lips (2 points); ? astringent pulse (2 points). The score can be diagnosed by adding =8 points; (5) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those who have been confirmed as acute coronary syndrome, severe myocarditis, severe arrhythmia, severe cardiac insufficiency (heart function grade IV or left ventricular ejection fraction (LVEF) 2 times the upper limit of the normal reference value, or Scr> 1.5 times the upper limit of the normal reference value), combined with serious primary diseases such as hematopoietic system, malignant tumors, Mentally ill (6) Women who are pregnant, planning to become pregnant or breast-feeding; (7) Participants in other clinical trials within the past 3 months; (8) Those who are allergic to the test drug or its ingredients; (9) The investigator believes that it is unsuitable to participate in the clinical trial patients and patients who do not cooperate and have poor compliance due to other reasons.

Design outcomes

Primary

MeasureTime frame
Seattle Angina Questionnaire;

Secondary

MeasureTime frame
TCM Syndrome Score of Heart Blood Stasis Syndrome;SF36 quality of life scale score;Withdrawal rate and usage of nitroglycerin;

Countries

China

Contacts

Public ContactDazhuo Shi
shidazhuo@126.com13911972856

Outcome results

None listed

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