Fire dragon cupping for pediatric vomiting

ISRCTN	ISRCTN10327805
DOI	https://doi.org/10.1186/ISRCTN10327805
Sponsor	Rugao Traditional Chinese Medicine Hospital
Funder	Nantong Municipal Health Commission Research Project

Submission date: 28/01/2026
Registration date: 09/02/2026
Last edited: 05/02/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

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 Sun
Principal investigator, Scientific, Public

No. 269, Dasi Road, Rucheng Street, Rugao City
Nantong
226500
China

Phone	+86 (0)513 87512380
Email	SuXli689@163.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Fire dragon cupping combined with acupoint application for treating vomiting in children with spleen-stomach deficiency cold pattern: a randomised controlled trial
Study objectives
Ethics approval(s)	Approved 06/01/2025, Rugao Traditional Chinese Medicine Hospital (No. 269, Dasi Road, Rucheng Street, Rugao City, Nantong, 226500, China; +86 (0)513 87512380; rgszyyyb@163.com), ref: RGSZYYLL25019
Health condition(s) or problem(s) studied	Pediatric vomiting
Intervention	Participants were randomized 1:1 via computer-generated sequences, allocation concealed in sequentially numbered, opaque, sealed envelopes. Control Group: Children received dietary management (short-term fasting if needed, followed by a warm, bland, easily digestible diet with frequent small meals) and abdominal warmth, alongside TCM acupoint application. A medicinal paste was made from powdered Evodia rutaecarpa (5 g), monkshood (5 g), dried ginger (5 g), cassia twig (5 g), and asarum (3 g) mixed with honey, formed into a cake (2 cm diameter, ~0.2 cm thick), and placed on a 6 × 6 cm breathable patch (Cofoe). The patch was applied to cleansed skin at Shenque, Zhongwan, Neiguan, and Zusanli acupoints for 4–6 hours daily for 3 days. Any discomfort, itching, redness, or swelling was to be reported immediately. Observation Group: This group received the control group treatment plus comprehensive moxibustion using a fire dragon jar. Treatment emphasized the Ren meridian, with additional focus on the Du and Stomach meridians and Back-Shu points. Using a small bell-shaped jar containing a burning moxa cone, techniques included rotating, opening/closing the jar, acupressure, vibration, pushing, kneading, and hot compress. Children were positioned comfortably with skin lightly lubricated. In the supine position, the abdomen was treated (outside to inside) with emphasis on Zhongwan, Shenque, Guanyuan, Tianshu, and Daheng acupoints for 10–15 minutes. In the prone position, the back was treated along the Du meridian (Zhiyang to Dazhui) and the Bladder meridian (Fengmen to Weishu), focusing on Zhiyang, Dazhui, Pishu, and Weishu for 5–10 minutes. Treatment was given once daily for 3 days. Manipulation was gentle, stopping at slight skin redness and sweating to prevent burns. Post-treatment, children drank warm water, avoided wind/cold, and refrained from bathing on the day of treatment.
Intervention type	Other
Primary outcome measure(s)	Primary symptoms (vomiting, loss of appetite) and secondary symptoms (nausea, abdominal pain, loose stools, fatigue, pallor, etc) measured using TCM Syndrome Rating Scale for Infantile Vomiting with Syndrome of Deficient Cold of Spleen and Stomach at before and after treatment Clinical symptom disappearance time (vomiting, nausea, abdominal pain, poor appetite, loose stools) measured using family inquiry and physical examination at fixed daily intervals throughout the trial Clinical efficacy measured using the Guiding Principles for Clinical Research of New Chinese Medicine at post-treatment Adverse events (AEs) and serious AEs (SAEs) measured using monitoring and recording at throughout the trial Family satisfaction measured using a self-designed 4-point Likert scale survey at post-treatment
Key secondary outcome measure(s)
Completion date	21/10/2025

Eligibility

Participant type(s)
Age group	Child
Lower age limit	1 Year
Upper age limit	6 Years
Sex	All
Target sample size at registration	126
Total final enrolment	114
Key inclusion criteria	Children were included if they: 1. Met the diagnostic criteria for infantile vomiting (spleen‑stomach deficiency‑cold pattern) according to both Western medicine (Zhu Futang Practice of Pediatrics, 9th Edition) and TCM (Diagnostic and Therapeutic Efficacy Standards for Traditional Chinese Medicine Diseases and Syndromes) 2. Were aged 1–6 years 3. Presented with acute illness (≤48 hours) and mild‑to‑moderate vomiting severity (1–9 episodes/day) on the Nausea and Vomiting Gastric Dynamics Scale (NVG) 4. Had not used antiemetic/prokinetic drugs within 24 hours before enrollment 5. Had not participated in other clinical trials within the past 3 months 6. Had legal guardians who provided written informed consent
Key exclusion criteria	1. Vomiting due to other defined causes (e.g., intracranial hypertension, acute abdomen, intestinal obstruction, metabolic disorders) 2. Severe primary disease or mental disorder affecting cooperation 3. Known allergy to any drug or material used in the study (e.g., monkshood, asarum, ginger, moxa ash) 4. Skin lesions, eczema, dermatitis, ulcers, or scars at treatment sites 5. Severe NVG grading (projectile vomiting ≥10 times/day, or complications such as dehydration/electrolyte imbalance)
Date of first enrolment	09/01/2025
Date of final enrolment	06/08/2025

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

29/01/2026: Study's existence confirmed by the Rugao Traditional Chinese Medicine Hospital.