The effect of acupoint application therapy in children with chronic coughs of varying severity
| ISRCTN | ISRCTN83971033 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83971033 |
- Submission date
- 22/07/2025
- Registration date
- 24/07/2025
- Last edited
- 23/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
This study was designed to explore the effects of acupoint application on chronic cough of differing pain severity, based on validation of its efficacy in chronic cough, thereby guiding the clinical application of this therapy.
Who can participate?
Children aged 4 to 12 with chronic cough
What does the study involve?
Children with chronic cough were randomly divided into a control group and an observation group. Before receiving treatment, all participants underwent evaluation of cough symptoms and pain levels, which were used as baseline data to assess efficacy.
Control Group: After 2 weeks of diagnostic bronchodilator therapy and empirical inhaled corticosteroids (ICS), a reassessment was performed. Treatment involved a single medication or a combination of two to three medications administered via nebulisation, with dosages and methods adjusted according to clinical needs, along with routine symptomatic treatments for allergies, spasms and asthma.
Observation Group: In addition to the treatment given to the control group, the observation group underwent acupoint application therapy. Referencing the external treatment methods for cough (the syndrome of qi deficiency of the lung and spleen) outlined in the national textbook Pediatrics in Chinese Medicine, edited by Wang Shouchuan, the acupoint application was performed as follows: 12 g of cinnamon, 16 g of clove, 10 g of cassia twig, 15 g of frankincense, 10 g of Codonopsis pilosula, 10 g of Astragalus membranaceus and 30 g each of Angelica sinensis, safflower, red peony, chuanxiong and tuberculate Speranskia herb were ground into fine powder (100 mesh) and sealed in a bottle for later use. When used, the powder was mixed with honey to form a paste or shaped into pills the size of peanuts, followed by placing the prepared medicine in the centre of a sterile dressing.
Acupoint Selection: Days 1–2: Pills were used at the acupoints of Tiantu and Danzhong; pastes were used bilaterally at both Dingchuan and Feiyu. Days 3–5: Pastes were used at the acupoints of Zhongwan, Shenque, Qihai and Guanyuan.
Selection of Application Method: The skin was cleaned with alcohol, and the patient lay supine to ensure stable application of the medicine. The sterile dressing was then placed on the designated acupoints and gently pressed to ensure full contact between the medicine and the acupoints, followed by securing it with adhesive tape. The application was performed once daily and removed after approximately 4 hours, with a treatment course of 5–7 days. The total intervention lasted 2 weeks.
What are the possible benefits and risks of participating?
Benefits: Traditional Chinese medicine can be used as a complementary treatment when conventional treatments are ineffective. Acupoint application is effective in treating chronic cough in children, significantly improving symptoms of chronic cough and increasing patient satisfaction.
Risks: Skin scraping and acupoint application may cause adverse reactions such as skin allergies, nausea, vomiting, and diarrhea.
Where is the study run from?
1. Guangdong Provincial Hospital of Traditional Chinese Medicine, China
2. Guangzhou Twelfth People’s Hospital, China
When is the study starting and how long is it expected to run for?
April 2023 to December 2024
Who is funding the study?
1. Guangdong Provincial Hospital of Traditional Chinese Medicine, China
2. Guangzhou Twelfth People’s Hospital
Who is the main contact?
Dr Lifang Lei, leifangli_ll70@163.com
Contact information
Public, Scientific, Principal Investigator
No. 111, Dade Road, Yuexiu District
Guangzhou, Guangdong
511400
China
| Phone | +86 13543478921 |
|---|---|
| leifangli_ll70@163.com |
Study information
| Study design | Randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effect of acupoint application therapy |
| Study objectives | To explore the efficacy of acupoint application therapy in children with chronic coughs of varying severity |
| Ethics approval(s) |
Approved 30/05/2023, Medical Ethics Committee of Guangzhou No. 12th People’s Hospital (No. 111, Dade Road, Yuexiu District, Guangzhou, Guangdong, 511400, China; +86 020-62134001; gz12yy@126.com), ref: 2023082 |
| Health condition(s) or problem(s) studied | Children with chronic coughs of varying severity |
| Intervention | One hundred children with chronic cough were randomly divided into a control group (n=50) and an observation group (n=50). Participants will be randomly assigned (1:1 ratio) to either group according to a computer-generated sequence, with odd-numbered participants assigned to the control group receiving bronchodilator therapy and empirical inhaled corticosteroids conventional treatment, and even-numbered participants assigned to the observation group receiving acupoint application therapy in addition to conventional treatment. To avoid the influence of the subjective consciousness of evaluators on the results, two full-time personnel were arranged to conduct efficacy evaluations. The personnel conducting the efficacy evaluation did not participate in other aspects of this study, such as enrolment and intervention. Before receiving treatment, all participants underwent evaluation of cough symptoms and pain levels, which were used as baseline data to assess efficacy. Control Group: After 2 weeks of diagnostic bronchodilator therapy and empirical inhaled corticosteroids (ICS), a reassessment was performed. The following bronchodilators were used: Ipratropium bromide solution for inhalation (Joincare Pharmaceutical Group Industry Co. Ltd., Approval No.: GYZZ H20203454, product specification: 0.5 mg/vial) Terbutaline sulphate solution for nebulisation (Joincare Pharmaceutical Group Industry Co. Ltd., Approval No.: GYZZ H20223371, product specification: 5 mg/vial) Salbutamol sulphate solution for inhalation (Suzhou Homesun Pharmaceutical Co. Ltd., Approval No.: GYZZ H20203292, product specification: 5 mg/vial) Empirical ICS included: Budesonide suspension for inhalation (Sichuan Purity Pharmaceutical Co. Ltd., Approval No.: GYZZ H20213286, product specification: 1 mg/vial) Fluticasone propionate (GlaxoSmithKline Pty Ltd., Imported Drug Registration No.: H20170361, product specification: 0.5 mg/vial) Treatment involved a single medication or a combination of two to three medications administered via nebulisation, with dosages and methods adjusted according to clinical needs, along with routine symptomatic treatments for allergies, spasms and asthma. Observation Group: In addition to the treatment given to the control group, the observation group underwent acupoint application therapy. Referencing the external treatment methods for cough (the syndrome of qi deficiency of the lung and spleen) outlined in the national textbook Pediatrics in Chinese Medicine, edited by Wang Shouchuan, the acupoint application was performed as follows: 12 g of cinnamon, 16 g of clove, 10 g of cassia twig, 15 g of frankincense, 10 g of Codonopsis pilosula, 10 g of Astragalus membranaceus and 30 g each of Angelica sinensis, safflower, red peony, chuanxiong and tuberculate Speranskia herb were ground into fine powder (100 mesh) and sealed in a bottle for later use. When used, the powder was mixed with honey to form a paste or shaped into pills the size of peanuts, followed by placing the prepared medicine in the centre of a sterile dressing. Acupoint Selection: Days 1–2: Pills were used at the acupoints of Tiantu and Danzhong; pastes were used bilaterally at both Dingchuan and Feiyu. Days 3–5: Pastes were used at the acupoints of Zhongwan, Shenque, Qihai and Guanyuan. Selection of Application Method: The skin was cleaned with alcohol, and the patient lay supine to ensure stable application of the medicine. The sterile dressing was then placed on the designated acupoints and gently pressed to ensure full contact between the medicine and the acupoints, followed by securing it with adhesive tape. The application was performed once daily and removed after approximately 4 hours, with a treatment course of 5–7 days. The total intervention lasted 2 weeks. |
| Intervention type | Mixed |
| Primary outcome measure | Cough symptoms will be measured using the cough symptom diurnal scoring system and cough symptom questionnaire, referencing the Diagnostic Standards for Efficacy of Syndrome in Traditional Chinese Medicine, before treatment and 2 weeks after treatment |
| Secondary outcome measures | The pain level was measured using a Visual Analog Scale (VAS) before treatment and 2 weeks after treatment |
| Overall study start date | 01/04/2023 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient, Carer |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Aged 4–12 years 2. Meeting the relevant diagnostic criteria of both TCM and Western medicine as stated above 3. Obvious organic diseases or other severe complications 4. Patients and their parents or guardians willing to participate in the study and able to provide informed consent. |
| Key exclusion criteria | 1. Severe respiratory complications, e.g. pneumonia or bronchial asthma 2. Received other specific treatments for cough, e.g. antibiotic therapy or immunomodulatory therapy, within the past 3 months 3. Unable to cooperate with acupoint application procedures due to age, cognitive ability or other reasons |
| Date of first enrolment | 01/06/2023 |
| Date of final enrolment | 30/10/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Guangzhou, Guangdong
511400
China
Sponsor information
Hospital/treatment centre
No. 111, Dade Road, Yuexiu District
Guangzhou, Guangdong
511400
China
| Website | https://www.gdhtcm.com/ |
|---|---|
"ROR" |
https://ror.org/01gb3y148 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Location
- China
No information available
Results and Publications
| Intention to publish date | 30/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Editorial Notes
22/07/2025: Study's existence confirmed by the Medical Ethics Committee of Guangzhou No. 12th People’s Hospital, China.
