Study of Herbal Formula Corresponding to Syndrome in Treating Post Percutaneous Coronary Intervention (PCI) Patients With Coronary Heart Disease (CHD)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Coronary Heart Disease

Treatments: Drug: Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules; Drug: Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules; Drug: Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,

Study type: Interventional

Funder types: Other

Identifiers

NCT00817024

NNSF90709048

Details and patient eligibility

About

We conduct this clinical trial to determine the effects of Xuefu Zhuyu capsule (based on TCM "Zheng Hou" theory) in helping recovery from coronary heart disease(CHD)after PCI and find out whether this kind of effecacy is much better within patients administered with TCM syndrome-based individualized medication.

Full description

The effectiveness of a Chinese herbal formulae is not completely based on the disease or some biomedical indexes, but much more on the TCM syndrome(Chinese name:Zheng Hou)which is generalized from patients' TCM signs and symptoms. Thus, conventional medical curative effecacy evaluation system seems not to so fit for TCM clinical studies. Although many clinical studies from Chinese literature have reported the beneficial effects of various of TCM herbal agents in improving symptoms and signs as well as antagonism of specific pathological changes in CHD patients, most of these trials are lack of well-designed methodologies and the reliability of results still remains unclear. Therefore, we designed this clinical trial, with a randomized, placebo controlled way, to evaluate the curative effects of Xuefu Zhuyu capsule(a Chinese herbal medicine)in patients with Post-PCI CHD patients and find out whether this effects will be better displayed within subjects administered with syndrome-based individualized medication.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-75 years old
• Clinical diagnosis of coronary heart disease (confirmed by coronary angiography)
• Successfully received interventional therapy (PTCA or PCI)
• belong to TCM blood-stasis syndrome
• Must be able to swallow tablets
• Able to give written informed consent

Exclusion criteria

• Symptomatic congestive heart failure(New York Heart Association class III-IV)
• Females during pregnancy or lactation
• Serious dysfunction in important organs (liver, lung, kidney，et al)
• Use of concomitant Chinese herbal medicine
• Already attend other clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

90 participants in 3 patient groups, including a placebo group

Xuefu Zhuyu Capsules

Experimental group

Treatment:

Drug: Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,

Sheng Mai Capsules

Active Comparator group

Treatment:

Drug: Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules