Asthma Respiratory Asthma
Conditions
Interventions
Intervention: Acupuncture
Co-intervention: Ventolin inhaler. Patient will use inhalation when necessary.
This study involves patients with chronic persistent moderate bronchial asthma meeting the in
associated points: Taiyuan LU9, Yuji LU10, Zhongfu LU1).
Group 2:
The second group includes participants that will receive treatment according to the large intestine system with corresponding acupunc
associated points: Pianli LI6, Wenliu LI7, Dachangshu BL25).
Group 3:
The third group includes participants that will receive treatment according to both lung and large intestine system with correspo
associated points: Quchi LI 11, Hegu LI 4, Tianshu ST25, Shangjuxu ST37).
Group 4:
The fourth group, not undergoing treatment, is used as the control group.
All the subjects in the above four group
Sponsors
Ministry of Science and Technology (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluation indicators of clinical efficacy: 1.1. Asthma grading criteria according to the Guide for Prevention and Treatment of Asthma 2008: totally controlled, partly controlled, uncontrolled 1.2. Pulmonary function: forced vital capacity (FVC), FEV1, PEF, maximal mid-expiratory flow rate (MMFF), 50% of vital capacity peak expiratory flow rate (V50) and 25% of vital capacity peak expiratory flow rate (V25). Each test should be repeated three times retaining the best scores as basic values. Pulmonary function tests should be carried out before treatment and 1 - 3 days after the third treatment course. FEV1 indicates the function of both the large and small air passage, especially the large air passage. MMFF, V50, V25 indicate the problems of small air passage and PEF indicates problem of large air passage. 1.3. Evaluation of Chinese Medicine clinical pattern changes in asthma before and after treatment, using asthma evaluation scales: 1.3.1. Asthma Control Questionnaire (ACQ) used to evaluate the patient asthmatic condition within the past week 1.3.2. Asthma Control Test (ACT) used to evaluate the patient asthmatic condition within the past four weeks 1.3.3. Asthma Quality of Life Questionnaire (AQLQ) used to evaluate the asthmatic patient quality of life within the past two weeks 1.4. Patient diary: should contain night time wakening episodes, morning asthma symptoms, movement restriction, dyspnoea, wheezing, number of inhalations and PEF value 2. Impact on asthma pathogenesis: 2.1. Immunological impact: differences in the serum levels of interleukin-4 (IL-4), interleukin-5 (IL-5) and immunoglobulin E (IgE) before and after treatment 2.2. Impact on airways inflammation: difference in serum eosinophil (EOS) count and serum eosinophil cationic protein (ECP) levels before and after treatment 2.3. Impact on the pituitary-hypothalamic-adrenal axis: difference in serum cortisol level before and after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction and safety evaluation 1. Reporting adverse reaction: circumstances of adverse reaction due to improper manipulation technique, should be recorded in details in the specific adverse reaction questionnaire (condition, symptoms, occurrence date, duration). Unrecorded data will be considered as subjective symptoms. Any adverse effect occurring during the trial should be accurately reported and recorded. 2. Reporting adverse reaction: symptoms following acupuncture needling (type, timing, severity, localisation, cause and effect relation. etc.) should be recorded and filed. Its content should be based on clinical trial management standards and stated in the patient case report form. | — |
Countries
China
Outcome results
None listed