Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-03-01 @ 10:01 AM
Study NCT ID:
NCT02280850
Status:
UNKNOWN
Last Update Posted:
2014-11-03
First Post:
2014-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina
Sponsor:
Shaanxi Buchang Pharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina: A Randomised, Double-blind, Placebo-controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2014-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: