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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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. Sponsor: Shaanxi Buchang Pharmaceutical Co., Ltd

    Current Primary Outcome:

    • Therapeutic effect to Angina ( Average value of angina frequency) [ Time Frame: 6 weeks ]
      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).
    • Exercise treadmill testing (ETT) [ Time Frame: 4 weeks ]
      ST-segment displacement in electrocardiogram: Observe ST-segment displacement of J point after 60ms, including the degree of ST-segment depression.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Usage of nitroglycerine per day (average value) [ Time Frame: 4 weeks ]
    • Seattle Angina Ques-tionnaire (SAQ) [ Time Frame: 4 weeks ]
    • Scores on Chinese medical syndrome scale [ Time Frame: 4 weeks ]
      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)
    • Electrocardiogram manifestation [ Time Frame: 4 weeks ]
      Compare the changes of electrocardiogram manifestation (such as ST segment, T wave) of angina before and after treatment.
    • Time of angina break out from exercise beginning in ETT [ Time Frame: 4 weeks ]
    • Time of ST below 1 mm from exercise beginning in ETT [ Time Frame: 4 weeks ]


    Original Secondary Outcome: Same as current

    Information By: Shaanxi Buchang Pharmaceutical Co., Ltd

    Dates:
    Date Received: October 23, 2014
    Date Started: October 2014
    Date Completion: October 2015
    Last Updated: October 29, 2014
    Last Verified: October 2014