NCT02280850

Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina

Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina: A Randomised, Double-blind, Placebo-controlled Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shaanxi Buchang Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

1\. Procedures 1.1 Start-up stage (-14\~0 Day) 1. Inquire medical history, medication use, accompanied treatment, etc; 2. Sign informed consent; 3. Measure vital signs and conduct physical examination; 4. Record symptom and signs; 5. Confirm inclusion/exclusion criteria, and put patients who meet inclusion criteria into start-up stage; 6. Record participators' history of angina pectoris and treatment, or select stable angina from outpatient service (without medicate); 7. Allocate screen number, hand out Guanxi Shutong Capsules Placebo and record card of angina/nitroglycerin used; 8. Advise patient return visit with an empty belly 2 weeks later. 1.2 Interview 1 (Baseline 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. Withdraw remained drugs and box, and record card; 6. Hand out the drugs for 2 weeks and record card of angina/nitroglycerin used; 7. Advise patient return visit 2 weeks later. 1.4 Interview 3 (28±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.

Conditions

• Angina, Stable

Interventions

Type	Name	Description
DRUG	Guanxin Shutong Capsule	3 capsules three times a day; Duration: 4 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
DRUG	Placebo Capsule	3 capsules three times a day; Duration: 4 weeks.
DRUG	nitroglycerine	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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-06-01
• Completion: 2015-10-01
• First posted: 2014-11-03
• Last updated: 2014-11-03

Locations

1 site across 1 country: China