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Trial record 2 of 6 for:    olibanum

Acupoint Application in Patients With Stable Angina Pectoris (AASAP) (AASAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02029118
Recruitment Status : Unknown
Verified September 2014 by Chengdu University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : January 7, 2014
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine

Brief Summary:
Hypothesis: acupoint application is effective for managing chronic stable angina pectoris. Aim: to evaluate the efficacy and safety of acupoint application on the specific acupoints for chronic stable angina pectoris. Design: A Randomized, Controlled,Double Blind trial. 200 participants will be included. Four arms: herbal medicine application on acupoint group , placebo application on acupoint group , herbal medicine application on non-acupoint group and placebo application on non-acupoint group.

Condition or disease Intervention/treatment Phase
Stable Angina Pectoris Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech) Device: acupoint Drug: Aspirin: 100mg qd; Metoprolol:25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn. Early Phase 1

Detailed Description:
Acupoint application with herbal medicine is a kind of external treatment of traditional Chinese medicine and has a long history in China, which is use herbal medicine made of plaster and stick to specific acupoints, using the double effects of acupoints and herb to treat disease. In China, acupoint application with herbal medicine has been used in clinical treatment of angina pectoris, but there is no convincing evidence for the efficacy of acupoint application for angina pectoris, due to low methodologic quality and small sample size. The investigators designed the Randomized, Controlled, Double Blind clinical trial to investigates the efficacy of acupoint application in treating angina pectoris, the purpose of this study is to provide the convincing evidence for acupoint application treatment of angina pectoris.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Acupoint Application With Herbal Medicine in Patients With Stable Angina Pectoris: Randomized, Controlled,Double Blind Clinical Study
Study Start Date : October 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Herbal application on acupoint group
Containing the herbal medicine application on the specific acupoints plus foundation treatment
Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)
Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.
Other Name: Herbal medicine application

Device: acupoint
select acupoint according to traditional Chinese medicine
Other Name: acupuncture point

Drug: Aspirin: 100mg qd; Metoprolol:25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
foundation treatment
Other Name: basic treatment

Placebo Comparator: Placebo application on acupoint
Not containing herbal medicine application on the specific acupoints plus foundation treatment
Device: acupoint
select acupoint according to traditional Chinese medicine
Other Name: acupuncture point

Drug: Aspirin: 100mg qd; Metoprolol:25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
foundation treatment
Other Name: basic treatment

Placebo Comparator: Herbal application on non-acupoint group
Containing the herbal medicine application on the non-acupoints plus foundation treatment
Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)
Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.
Other Name: Herbal medicine application

Drug: Aspirin: 100mg qd; Metoprolol:25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
foundation treatment
Other Name: basic treatment

Sham Comparator: Placebo application on non-acupoint
Not containing herbal medicine application on the non-acupoints plus foundation treatment
Drug: Aspirin: 100mg qd; Metoprolol:25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
foundation treatment
Other Name: basic treatment




Primary Outcome Measures :
  1. Change from Baseline Number of angina attacks at 12 weeks [ Time Frame: at baseline,4, 8weeks after inclusion ]
    The change frequency of angina attack during every 4-week.


Secondary Outcome Measures :
  1. Change from Baseline the severity of angina ( VAS score) at 12 weeks [ Time Frame: at baseline,4, 8weeks after inclusion ]
    The VAS score evaluation angina pain severity

  2. Change from Baseline the dosage of nitroglycerin at 12 weeks [ Time Frame: at baseline,4, 8weeks after inclusion ]
    Observed reduction in the dose of nitroglycerin

  3. Seattle Angina Questionnaire [ Time Frame: at baseline,4, 8weeks after inclusion ]
  4. self-rating anxiety scale [ Time Frame: at baseline,4, 8weeks after inclusion ]
  5. Self-rating Depression Scale [ Time Frame: at baseline,4, 8weeks after inclusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.Meet the diagnostic criteria of American College of Cardiology(ACC)/American Heart Association (AHA) angina pectoris of coronary heart disease.

2.35 ≤ age ≤ 85 years, both male and female.

3.The onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week.

4.Patients signed the informed consent

Exclusion Criteria:

  1. age≤35 or age≥85.
  2. Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
  3. history of diabetes.
  4. Co-infection or bleeding, allergic.
  5. Currently participating in other clinical trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029118


Contacts
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Contact: Yulan Ren 13689098226 912795954@qq.com

Locations
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China, Sichuan
Affiliated hospital of Chengdu University of TCM Recruiting
Chengdu, Sichuan, China, 610072
Contact: Dehua Li    18980079361    1259362295@qq.com   
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Fanrong Liang Chengdu University of TCM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02029118     History of Changes
Other Study ID Numbers: 2011SZ0302.2
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Chengdu University of Traditional Chinese Medicine:
Acupoint Application,Stable Angina Pectoris,herbal medicine

Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Atorvastatin
Ramipril
Metoprolol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents