A study on the application of hufu copper bian scraping combined with acupoint application in patients with community-acquired pneumonia of phlegm-heat obstructing the lung syndrome-a randomized controlled study
| ISRCTN | ISRCTN35737468 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35737468 |
| Hebei Provincial Health Commission Project Number | 20250957 |
| Sponsor | Affiliated Hospital of Hebei University of Engineering |
| Funder | Health Commission of Hebei Province |
- Submission date
- 06/11/2026
- Registration date
- 10/11/2026
- Last edited
- 09/11/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Xiaoli Wang
Principal investigator
Principal investigator
No. 81 Congtai Road, Congtai District
Handan
056002
China
| Phone | +86 03103962030 |
|---|---|
| Wangxiaoli_16@163.com |
Dr Pengfei Wang
Public
Public
No. 81 Congtai Road, Congtai District
Handan
056002
China
| Phone | +86 03103962030 |
|---|---|
| pengfei3_4t@outlook.com |
Dr Yan Zhao
Scientific
Scientific
No. 81 Congtai Road, Congtai District
Handan
056002
China
| Phone | +86 03103962030 |
|---|---|
| Zhaoyan_11@21cn.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | A study of phlegm-heat obstructing the lung syndrome |
| Study objectives | |
| Ethics approval(s) |
Approved 10/12/2023, Affiliated Hospital of Hebei University of Engineering (No. 81 Congtai Road, Congtai District, Handan City, 056002, China; +86-0310 3130866; hbgdfy2000@163.com), ref: 2026 [K]038 |
| Health condition(s) or problem(s) studied | Community-acquired pneumonia (CAP), specifically non-severe CAP in adults with the traditional Chinese medicine syndrome of phlegm-heat obstructing the lung. |
| Intervention | Randomization was performed using a random number table as follows: 1. All patients were numbered according to the order of inclusion 2. Starting from any row and column of the random number table, random numbers equal to the sample size were copied in a predetermined direction (e.g., left to right, top to bottom) 3. Patients were divided directly according to the parity of the random number: odd numbers into the experimental group, even numbers into the control group 4. If the number of patients in each group was unequal, random numbers were continued to be drawn for the excess subjects in the same way until the numbers in both groups were equal For allocation concealment: 1. The grouping sequence and allocation scheme were generated by designated researchers using a random number table 2. Personnel who were aware of the group information no longer participated in the recruitment and allocation of subsequent subjects 3. The generated random allocation table was entrusted to independent personnel not involved in this trial, and sealed, opaque envelopes were used one by one during actual allocation to ensure concealment of the allocation scheme Control arm: Conventional Western medicine: levofloxacin sodium chloride injection 100 mL by intravenous infusion once daily (adjusted according to drug susceptibility results when available); ambroxol hydrochloride sodium chloride injection 100 mL by intravenous infusion twice daily. Treatment duration: 12 consecutive days. Study arm: Same conventional Western medicine as the control arm, plus: Hufu copper bian scraping: scraping along the Heart Meridian of Hand-Shaoyin, Lung Meridian of Hand-Taiyin, Large Intestine Meridian of Hand-Yangming, Sanjiao Meridian of Hand-Shaoyang, Du Meridian, and Bladder Meridian of Foot-Taiyang, and the Four Opening Points (Dazhui, Dazhu, Gaohuangshu, Shentang). Each session lasted approximately 30 minutes, once every 3 days, with 2 sessions constituting one course, over 12 days. Herbal acupoint application: a paste made from roasted Ephedra sinica 9 g, raw Rheum palmatum 9 g, Perilla frutescens 9 g, Sinapis alba 6 g, and Mentha haplocalyx 3 g, ground into fine powder and mixed with honey, applied to Danzhong (CV17), bilateral Feishu (BL13), and bilateral Fenglong (ST40). Applied once daily for 2–4 hours each time, over 12 days. Both groups received continuous treatment for 12 days. The outcomes involve the Clinical Pulmonary Infection Score (CPIS) measured using CPIS, a 6-item score with a total range of 0–12 points (body temperature, blood white cell count, tracheal secretions, oxygenation index, chest X-ray infiltration, and tracheal aspirate/sputum culture); higher scores indicate more severe pulmonary infection. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 10/01/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 101 |
| Total final enrolment | 101 |
| Key inclusion criteria | 1. Adults diagnosed with non-severe community-acquired pneumonia (CAP) according to the Chinese Guidelines for the Diagnosis and Treatment of Adult CAP (2016 edition) 2. Meeting the traditional Chinese medicine diagnostic criteria for CAP of phlegm-heat obstructing the lung syndrome according to the Chinese Medicine Guidelines for CAP (2018 revised edition) 3. Aged 18–70 years 4. Voluntary participation with signed informed consent |
| Key exclusion criteria | Key exclusion criteria: 1. Pregnant or lactating women 2. Patients with severe hepatic or renal insufficiency 3. Patients with diabetes mellitus, severe skin diseases, or severe cardiovascular and cerebrovascular diseases 4. Patients with mental illness or inability to cooperate with the study 5. Patients with allergy to Chinese herbal medicine or acupoint application Dropout/exclusion criteria: 1. Severe adverse reactions or complications preventing continuation of the study 2. Incomplete clinical data due to failure to strictly follow the study protocol for medication and examinations 3. Voluntary withdrawal from the study |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 30/12/2024 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
06/11/2026: Study’s existence confirmed by the Hebei University of Engineering Affiliated Medical Ethics Committee, China.
