Acupuncture clinical trial for chronic persistent moderate bronchial asthma

Completed

• Conditions: Asthma; Respiratory

• Registration Number: ISRCTN99395260
• Lead Sponsor: Ministry of Science and Technology (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified