Chaigui Longmu Ejiao Paste for Ischemic Heart Disease

Average weekly reduction in angina attack frequency

The mean change in the average number of angina attacks per week from baseline to the end of the 8-week treatment period in patients with ischemic heart disease ; Recorded using electronic patient-reported outcomes (ePRO).

Change from Baseline in Seattle Angina Questionnaire (SAQ) Scores

The Seattle Angina Questionnaire (SAQ) is a validated, disease-specific, self-reported instrument that assesses health status in patients with angina due to ischemic heart disease. It measures five domains: Physical Limitation (extent of limitation in physical activity due to angina), Angina Stability (change in angina frequency over the past 4 weeks), Angina Frequency (frequency and burden of angina episodes), Treatment Satisfaction (satisfaction with angina treatment), and Disease Perception/Quality of Life (impact of angina on quality of life). Each domain is scored from 0 to 100, with higher scores indicating better health status (less limitation, fewer symptoms, greater satisfaction, better quality of life). Change = (Week 4 or Week 8 Score - Baseline Score) for each domain and the total score (overall summary score, if applicable, averaging the relevant domains).

Average Weekly Nitroglycerin Consumption

The average number of nitroglycerin tablets (or sublingual sprays) used per week by the participant to relieve angina symptoms. This is a key indicator of angina burden and rescue medication requirement.

Change from Baseline in Traditional Chinese Medicine (TCM) Syndrome Score

The TCM Syndrome Score is a composite system based on the diagnostic criteria for the pattern "Chest Yang Deficiency with Heart Vessel Stasis". It assesses severity of: * Primary symptoms (chest oppression/chest pain, palpitations) * Secondary symptoms (insomnia, aversion to cold, spontaneous sweating, irritability/restlessness of heart and mind) Tongue and pulse are observed but not scored numerically. Scoring: * Primary symptoms: 0 (absent), 2 (mild), 4 (moderate), 6 (severe) * Secondary symptoms: 0 (absent), 1 (mild), 2 (moderate), 3 (severe) Total score = sum of all symptom scores. Higher score = greater severity. Change value * score at week 4 or 8 - baseline score A lower (more negative) change value indicates greater improvement in the TCM syndrome.

Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score

The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered, 14-item instrument that assesses the severity of anxiety symptoms. Each item is scored from 0 (none) to 4 (severe), with a total score ranging from 0 to 56 (higher scores indicate greater anxiety severity). The scale are administered by trained clinicians. Change = (Week 4 or Week 8 total score - Baseline total score) for each scale. Negative changes indicate improvement (reduction) in anxiety symptoms.

Vital Signs (Body Temperature)

Vital signs are monitored as a key safety parameter to evaluate the physiological tolerability and potential adverse effects of the investigational treatment. Body temperature (°C) is measured under standardized conditions (rest ≥5 minutes, using calibrated equipment) by trained study personnel.

Vital Signs (Pulse Rate)

Vital signs are monitored as a key safety parameter to evaluate the physiological tolerability and potential adverse effects of the investigational treatment. Pulse rate (beats per minute, bpm) is measured under standardized conditions (rest ≥5 minutes, using calibrated equipment) by trained study personnel.

Vital Signs (Respiratory Rate)

Vital signs are monitored as a key safety parameter to evaluate the physiological tolerability and potential adverse effects of the investigational treatment. Respiratory rate (breaths per minute) is measured under standardized conditions (rest ≥5 minutes, using calibrated equipment) by trained study personnel.

Vital Signs (Blood Pressure)

Vital signs are monitored as a key safety parameter to evaluate the physiological tolerability and potential adverse effects of the investigational treatment. Blood pressure (systolic and diastolic, mmHg) is measured under standardized conditions (rest ≥5 minutes, using calibrated equipment) by trained study personnel. Both systolic blood pressure (SBP) and diastolic blood pressure (DBP) are recorded and reported separately.