ISRCTN99395260已完成不适用
Basic research according to Zang Fu theory about lungs and large intestine exterior-interior relationship, based on the study of the lungs and large intestine connection through their meridian points having an exterior-interior relationship with common therapeutic effects: a pilot trial
Ministry of Science and Technology (China)0 个研究点目标入组 52 人开始时间: 2010年7月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Subjects diagnosed as persistent moderate bronchial asthma according to its chronic and persistent characteristics
- •2. Subjects with recurrent wheezing, breathlessness, chest tightness or cough experienced persistently over a period of six months and within ten years
- •3. Positive bronchial dilation test: more than 12% increase in forced expiratory volume in one second (FEV1) and more than 200 ml increase in FEV1 absolute value
- •4. Age range: 18 - 60 years
- •5. Inclusion of both sexes
- •6. Subjects having the capacity to describe their consent, voluntarily fill in the informed consent form and agree to participate in the clinical trial
- •7. Subjects that do not correspond to the exclusion criteria and meet the above requirements
排除标准
- •1. Subjects affected by respiratory tract infection, cardiac asthma, chronic asthmatic bronchitis, lung cancer, allergic pulmonary infiltration that may lead to wheezing
- •2. Subjects with history of life threatening asthma with tracheal intubation and mechanical ventilation
- •3. Subjects with acute asthma episode in the past month (showing abrupt onset of wheezing, cough, chest tightness or severe worsening of previous symptoms such as dyspnoea characterised by reduced expiratory flow and often due to irritative agents such as allergen in exposure or inappropriate treatment. Severity varies with condition worsening that can appear within hours or days, with incidental life threatening episodes that can occur in minutes).
- •4. Subjects with severe dependence on beta-2-adrenergic receptor agonists exceeding 4 inhalations (8 sprays) per day
- •5. Subjects with apparent thoracic malformation, organic lung disease or lobectomy
- •6. Subjects suffering from coexistent cardiac diseases or arrhythmia
- •7. Subjects with coexistent hyperthyroidism
- •8. Subjects suffering from infectious conditions such as tuberculosis, hepatitis or with creatinine or aspartate aminotransferase (AST)/alanine aminotransferase (ALT; GPT) twice higher than normal values
- •9. Subjects taking glucocorticoid medication orally (per os) or intravenously within the past month or by inhalation within the past week
- •10. Subjects on H1 antihistamine or leukotriene antagonist medication per os within the last 14 days
- •11. Subjects taking specific immunotherapy within the past year
- •12. Subjects with average peak expiratory flow (PEF) greater than or equal to 80% one week previous to acupuncture and with mutation rate of PEF less than 20%, or average PEF less than 60%
- •13. Subjects undergoing the following therapies, within the last month to treat their asthma:
- •13.1. Acupuncture, moxibustion, cupping, nasal inhalation or per os medication with Chinese medicine or other type of folk medicine within the last week
- •13.2. History of asthma homeopathic treatment or other type of complementary medicine
- •14. Subjects having taken part in other clinical trials within the last six months
- •15. Pregnant or breastfeeding women or women of childbearing potential planning pregnancy
- •16. Subjects with skin lesions on the needling site or suffering from diseases incompatible with needling
- •17. Subjects with night time occupation
- •18. Subjects that cannot sustain the trial requirement of three weekly acupuncture sessions during the three month treatment or that are considered unsuitable by the staff in charge of the trial
研究者
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