Efficacy of Woxuan Needling and Xiangsha Liujunzi Decoction in Helicobacter pylori-positive chronic gastritis
| ISRCTN | ISRCTN52976333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52976333 |
| Sponsor | Jiangxi Province Hospital of Integrated Chinese and Western Medicine |
| Funder | Jiangxi Province Hospital of Integrated Chinese and Western Medicine |
- Submission date
- 28/07/2026
- Registration date
- 14/08/2026
- Last edited
- 12/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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 Yiting Du
Principal investigator, Public, Scientific
Principal investigator, Public, Scientific
No. 1399 Diezihu Avenue, Honggutan District
Nanchang
330003
China
| Phone | +86 (0)15180482118 |
|---|---|
| du_yiting@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Efficacy of Woxuan needling and Xiangsha Liujunzi decoction on traditional Chinese medicine syndromes and gastric biomarkers in Helicobacter pylori-positive chronic gastritis |
| Study objectives | |
| Ethics approval(s) |
Approved 26/04/2021, Ethics Committee of Jiangxi Province Hospital of Integrated Chinese and Western Medicine (No. 1399 Diezihu Avenue, Honggutan District, Nanchang, 330003, China; +86 (0)791-86391701; nc2yhlb@163.com), ref: No. Yanlunwenpi [003] |
| Health condition(s) or problem(s) studied | Chronic non-atrophic gastritis in patients with Helicobacter pylori infection |
| Intervention | Participants are divided into an observation group and a control group using a random number table according to the order of enrolment. The control group receives basic drug treatment combined with Xiangsha Liujunzi decoction, whereas the observation group receives Woxuan needling in addition to the control treatment. The conventional Western medicine treatment plan is based on the Chinese Chronic Gastritis Diagnosis and Treatment Guide, which includes standard quadruple therapy. The specific medications are as follows: amoxicillin capsules (1 g) orally twice daily; furazolidone tablets (0.1 g) orally twice daily; 240 mg of bismuth potassium citrate (calculated as bismuth oxide) orally twice daily; and omeprazole enteric-coated capsules (20 mg) orally twice daily. These drugs are taken for 14 days. As a routine basic treatment, Xiangsha Liujunzi decoction is used. The prescription is as follows: 12 g of Dangshen, 12 g of Fuling, 12 g of Baizhu, 12 g of Chenpi, 12 g of Fabanxia, 6 g of Zhigancao, 8 g of Muxiang and 8 g of A. villosum (Houxia). One dose per day is decocted twice, yielding approximately 250 ml of juice, taken twice daily in the morning and evening. Treatment is administered continuously for 6 days, followed by a 1-day rest interval, for a total treatment duration of 2 months. On the basis of the treatment protocol of the control group, Woxuan needling is applied. The following acupoints are selected: Xinmen (right), Zusanli (right), Taichong (left), and Taibai (left). After skin disinfection, a 0.20 × 40 mm filiform needle is inserted. According to the acupuncture order of Woxuan needling, the following sequence is used: right heart door, right Zusanli, left Taichong, and left Taibai, quickly penetrating the skin in turn. During acupuncture, the needle tips at the right heart door and right Zusanli are directed downwards towards the distal end of the limb, whereas those at the left Taibai and left Taichong are directed upwards. After deqi, the right heart door and right Zusanli are gently twisted 5 times, and the left Taibai and left Taichong are twisted 10 times. The needles are retained for 30 minutes, during which the patients are required to close their eyes, breathe gently, keep their limbs warm, and remain comfortable. The procedure is performed three times a week for a total of 2 months. The general data of patients, TCM symptom scores, pepsinogen I (PGI), GAS, gastroscopy scores and gastrointestinal symptom rating scale (GSRS) scores are collected before treatment and 3 months after treatment. The evaluators who assess the indices receive standardised training before evaluation, and the grouping of participants is not disclosed to them. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 01/01/2023 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Aged >18 years 2. Diagnosis consistent with the above diagnostic criteria for chronic non-atrophic gastritis 3. H. pylori positive |
| Key exclusion criteria | 1. Suspected or diagnosed malignant lesions combined with severe dysplasia of gastric mucosa 2. Combined with haematological diseases or abnormal coagulation function 3. Needle phobia 4. Lactating or pregnant women 5. Complicated with severe primary diseases of the brain, heart, liver, kidney or other major organs or a history of mental illness 6. Combined with malignant tumour 7. Allergic to TCM ingredients used in this study |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 01/09/2022 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
31/07/2026: Trial's existence confirmed by Ethics Committee of Jiangxi Province Hospital of Integrated Chinese and Western Medicine.
