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Compared with placebo, assess of the efficacy and safety of Guanxin Shutong capsule to treat chronic stable angina (syndrome of blood stasis resistance), and the result will be used for the basis of later Ⅳ clinical trial.
1. Procedures 1.1 Start-up stage (-14~0 Day)
(1) Measure vital signs; (2)Accomplish all the examination items: Blood routines, Urine routines, Stool routines + Occult blood, Hepatorenal function (AST, ALT, TBIL, ALP, γ-GT, BUN, Cr), Four coagulation tests (TT, PT, APTT, FIB), Blood fat (TC, TG, HDL-C, LDL-C), 12 leads electrocardiogram, Seattle Angina Ques-tionnaire (SAQ). Additionally, premenopausal women receive urine pregnancy test; (3) Exercise treadmill testing (ETT): around am. 10:00 (Note: Just for the patients who need ETT); (4) Record symptoms and signs ( Score of syndrome of Chinese medicine and Score of angina); (5) Randomize and allocate drug number; (6) Hand out the drugs for 2 weeks and record card of angina/nitroglycerin used; (7) Advise patient return visit 2 weeks later. 1.3 Interview 2 (14±2 Day)
(1) Inquire adverse events; (2) Inquire accompanied treatment and record combined medication. (3) Measure vital signs; (4) Record symptoms and signs (Score of syndrome of Chinese medicine and Score of angina); (5) 12 leads electrocardiogram (6) Accomplish all the examination items: Blood routines, Urine routines, Stool routines + Occult blood, Hepatorenal function (AST, ALT, TBIL, ALP, γ-GT, BUN, Cr), Four coagulation tests (TT, PT, APTT, FIB), Blood fat (TC, TG, HDL-C, LDL-C), 12 leads electrocardiogram, Seattle Angina Ques-tionnaire (SAQ); (7) Exercise treadmill testing (ETT) (Note: Just for the patients who need ETT); (8) Withdraw remained drugs and box, and record card; (9) Assess compliance; (10) Summarize the clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guanxin Shutong Capsule | Experimental | 3 capsules once, tid, Oral Duration: 4 weeks |
|
| Placebo Capsule | Placebo Comparator | Placebo capsule and Guanxin Shutong Capsule the same appearance are made by SHAANXI BUCHANG PHARMACEUTICAL CO.,LTD. 3 capsules once, tid, Oral Duration: 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guanxin Shutong Capsule | Drug | 3 capsules three times a day; Duration: 4 weeks. Number of Cycles: until progression or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic effect to Angina ( Average value of angina frequency) | Record angina frequency per week. Record date is Start-up Stage 1st week, Start-up Stage 2st week, Interview Stage 1st week, Interview Stage 2st week, Interview Stage 3st week and Interview Stage 4st week (Toal of 6 times). | 6 weeks |
| Exercise treadmill testing (ETT) | ST-segment displacement in electrocardiogram: Observe ST-segment displacement of J point after 60ms, including the degree of ST-segment depression. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Usage of nitroglycerine per day (average value) | 4 weeks | |
| Seattle Angina Ques-tionnaire (SAQ) | 4 weeks | |
| Scores on Chinese medical syndrome scale |
| Measure | Description | Time Frame |
|---|---|---|
| Blood fat (TC, TG, HDL-C, LDL-C) | 4 weeks | |
| Degree and duration of angina attack. | 4 weeks |
Inclusion Criteria:
Symptom of chronic stable angina is sustained for 3 months or over 3 months (typical symptoms of myocardial ischemia occurred at least 2 times in the latest week, and angina type is stable angina (Canada CCS class Ⅰ、Ⅱ or Ⅲ);
Blood stasis resistance on traditional Chinese medicine syndrome differentiation;
Patients who meet the following any situation:
Written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han Yaling, Academician | Contact | +86-24-28856123 | guanxinshutong@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lv Shuzheng | Beijing Anzhen Hospital | Principal Investigator |
| Zhang Yan | The Affiliated Hospital of Liaoning Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of Shenyang Military Region | Shenyang | Liaoning | 110045 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31829173 | Derived | Li Y, Zhang L, Lv S, Wang X, Zhang J, Tian X, Zhang Y, Chen B, Liu D, Yang J, Dong P, Xu Y, Song Y, Shi J, Li L, Wang X, Han Y. Efficacy and safety of oral Guanxinshutong capsules in patients with stable angina pectoris in China: a prospective, multicenter, double-blind, placebo-controlled, randomized clinical trial. BMC Complement Altern Med. 2019 Dec 11;19(1):363. doi: 10.1186/s12906-019-2778-z. |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000618354 | guanxin shutong |
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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| Placebo Capsule | Drug | 3 capsules three times a day; Duration: 4 weeks. |
|
| nitroglycerine | Drug | Adults: 0.25mg-0.5mg (half pill or 1 pill) once, sub-lingual. One more pill per 5 minutes untill pain relief. If total dose is 3 pills in 15 minutes and the pain is still in, please seek medical advice urgently. The participators in both arms who have agina symptom will take Nitroglycerine. So the accumulated consumption of participators is the one of the maesuremnts. |
|
Primary symptom: Chest pains (0; Slight: 2; Moderate: 4; Severe: 6) Chest congestion (0; Slight: 2; Moderate: 4; Severe: 6) Secondary symptom: Palpitation (0; Slight: 1; Moderate: 2; Severe: 3) Shortness of breath (0; Slight: 1; Moderate: 2; Severe: 3) Insomnia (0; Slight: 1; Moderate: 2; Severe: 3) |
| 4 weeks |
| Electrocardiogram manifestation | Compare the changes of electrocardiogram manifestation (such as ST segment, T wave) of angina before and after treatment. | 4 weeks |
| Time of angina break out from exercise beginning in ETT | 4 weeks |
| Time of ST below 1 mm from exercise beginning in ETT | 4 weeks |
| Chen Bojun |
| The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine |
| Principal Investigator |
| Luo Wei | Xuzhou Central Hospital | Principal Investigator |
| Jiang Binghua | Shandong University of Traditional Chinese Medicine | Principal Investigator |
| Zhang Zhenxian | Luohe Hospital of Traditional Chinese Medicine | Principal Investigator |
| Xing Yanjun | First Hospital of Shijiazhuang City | Principal Investigator |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |