Poisoning PatientsNCT04941859
Medicine Acuity Patching Combined Massage in the Treatment of Patients With Acute Poisoning
A study testing acupoint massage and application in people with Poisoning Patients, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This topic in western medicine combined on the basis of gastric lavage therapy in patients with acute poisoning acupoint sticking of traditional Chinese medicine and acupuncture point massage treatment, aims to smoothly accelerate cleaning and discharge poison, increase the poisoning patients rescue success rate… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Poisoning Patients
- What is being tested?
- acupoint massage and application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with oral acute poisoning who were first diagnosed in our hospital and completed gastric lavage;
- The skin of umbilical cord and bilateral Zusanli acupoints had no injury, scar, rash and other skin diseases.
- The patient or the patient's family member signed the informed consent and expressed their willingness to receive treatment.
Who cannot join
- Patients with severe conditions requiring cardiopulmonary resuscitation or with severe trauma or multiple injuries;
- Patients with heart, brain, liver, kidney and hematopoietic system diseases and other serious primary diseases;
- Patients with a history of gastrointestinal diseases (such as postoperative cancer, intestinal obstruction, and large intestinal polyps) that affect gastrointestinal emptying;
- Failing to receive treatment according to regulations or taking poison again during hospitalization and unable to judge the curative effect.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hanzhou, Zhejiang, 310000
minfei yang, +8613757118252, 2200056@zju.edu.cn
About this study
Official title: The Study of Chinese Medicine Acuity Patching Combined Massage in the Treatment of Patients With Acute Poisoning and Stomach Washing
This topic in western medicine combined on the basis of gastric lavage therapy in patients with acute poisoning acupoint sticking of traditional Chinese medicine and acupuncture point massage treatment, aims to smoothly accelerate cleaning and discharge poison, increase the poisoning patients rescue success rate, improve patient quality of life, for the clinical treatment of acute poisoning provides a new method of TCM nursing, to further exert TCM nursing characteristics.
Read the detailed description
With the rapid development of national economy, people's exposure to a variety of chemicals, drugs and other opportunities to increase, the types of substances causing poisoning tend to be diversified, acute poisoning frequently occur. Data showed that in some regions of China, poisoning cases accounted for 2.7%~ 3.6% of the patients admitted to the emergency department in the same period , and 8.3 % of the patients rescued in the emergency department in the same period , and its fatality rate was higher than the total fatality rate in the emergency department . The incidence of poisoning was 18/100,000 in urban residents and 69.22/100,000 in rural areas, accounting for 10.7% of all deaths. Poisoning incident is an important part of national public health emergency management. According to the statistics of China's Ministry of Health in 2013, poisoning has entered the top five major causes of death in China, and the number of acute poisoning cases has been increasing year by year . The diagnosis and treatment of acute poisoning and the effective and rapid treatment have become an important task for emergency clinical workers.
- Conditions
- Poisoning Patients
- Being tested
- acupoint massage and application
- Keywords
- Acute oral intoxication, Acupoint application, Point massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupoint massage and applicationBehavioural
Patients in the experimental group were treated with acupoint application combined with acupoint massage on the basis of standard treatment for acute poisoning. When the patient began to launder the stomach, the acupoint was applied to Shenque (umbilical). After the end of the gastric launder, Shenque acupoint and Zusanli diarrhea method (referring to counterclockwise and strong stimulation) were massaged for 15 minutes, and the massage frequency was Q8H.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients in the experimental group were treated with acupoint application combined with acupoint massage on the basis of standard treatment for acute poisoning. When the patient began to launder the stomach, the acupoint was applied to Shenque (umbilical). After the end of the gastric launder, Shenque acupoint and Zusanli diarrhea method (referring to counterclockwise and strong stimulation) were massaged for 15 minutes, and the massage frequency was Q8H. Receives: Behavioral: acupoint massage and application |
| control group | No intervention | The treatment plan of control group was carried out according to the diagnosis and treatment standard of acute poisoning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
Incidence of complications within 24 hours of admission: including nausea, vomiting, and abdominal pain
Measured: one year
Time of first bowel movement
Time of first bowel movement
Measured: through study completion, an average of 1 year
patient duration of hospital stay
patient duration of hospital stay
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start8 Mar 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poisoning PatientsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- minfei yang, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941859
- Sponsor's protocol ID
- 2021-0023
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Chinese Medicine Acuity Patching Combined Massage in the Treatment of Patients With Acute Poisoning and Stomach Washing
- ClinicalTrials.gov ID
- NCT04941859
- Acronym / sponsor ID
- 2021-0023
- Conditions
- Poisoning Patients
- Keywords
- Acute oral intoxication, Acupoint application, Point massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This topic in western medicine combined on the basis of gastric lavage therapy in patients with acute poisoning acupoint sticking of traditional Chinese medicine and acupuncture point massage treatment, aims to smoothly accelerate cleaning and discharge poison, increase the poisoning patients rescue success rate, improve patient quality of life, for the clinical treatment of acute poisoning provides a new method of TCM nursing, to further exert TCM nursing characteristics.
Detailed description
With the rapid development of national economy, people's exposure to a variety of chemicals, drugs and other opportunities to increase, the types of substances causing poisoning tend to be diversified, acute poisoning frequently occur. Data showed that in some regions of China, poisoning cases accounted for 2.7%~ 3.6% of the patients admitted to the emergency department in the same period , and 8.3 % of the patients rescued in the emergency department in the same period , and its fatality rate was higher than the total fatality rate in the emergency department . The incidence of poisoning was 18/100,000 in urban residents and 69.22/100,000 in rural areas, accounting for 10.7% of all deaths. Poisoning incident is an important part of national public health emergency management. According to the statistics of China's Ministry of Health in 2013, poisoning has entered the top five major causes of death in China, and the number of acute poisoning cases has been increasing year by year . The diagnosis and treatment of acute poisoning and the effective and rapid treatment have become an important task for emergency clinical workers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: acupoint massage and applicationPatients in the experimental group were treated with acupoint application combined with acupoint massage on the basis of standard treatment for acute poisoning. When the patient began to launder the stomach, the acupoint was applied to Shenque (umbilical). After the end of the gastric launder, Shenque acupoint and Zusanli diarrhea method (referring to counterclockwise and strong stimulation) were massaged for 15 minutes, and the massage frequency was Q8H. |
| control group | No intervention | –The treatment plan of control group was carried out according to the diagnosis and treatment standard of acute poisoning. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with oral acute poisoning who were first diagnosed in our hospital and completed gastric lavage;
- The skin of umbilical cord and bilateral Zusanli acupoints had no injury, scar, rash and other skin diseases.
- The patient or the patient's family member signed the informed consent and expressed their willingness to receive treatment.
Key exclusion criteria (4 listed)
- Patients with severe conditions requiring cardiopulmonary resuscitation or with severe trauma or multiple injuries;
- Patients with heart, brain, liver, kidney and hematopoietic system diseases and other serious primary diseases;
- Patients with a history of gastrointestinal diseases (such as postoperative cancer, intestinal obstruction, and large intestinal polyps) that affect gastrointestinal emptying;
- Failing to receive treatment according to regulations or taking poison again during hospitalization and unable to judge the curative effect.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupoint massage and applicationPatients in the experimental group were treated with acupoint application combined with acupoint massage on the basis of standard treatment for acute poisoning. When the patient began to launder the stomach, the acupoint was applied to Shenque (umbilical). After the end of the gastric launder, Shenque acupoint and Zusanli diarrhea method (referring to counterclockwise and strong stimulation) were massaged for 15 minutes, and the massage frequency was Q8H. | Behavioural | experimental group |
Primary outcome
complications
Time frame: one year
Incidence of complications within 24 hours of admission: including nausea, vomiting, and abdominal pain
Time of first bowel movement
Time frame: through study completion, an average of 1 year
Time of first bowel movement
patient duration of hospital stay
Time frame: through study completion, an average of 1 year
patient duration of hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
minfei yang principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupoint massage and application in people with Poisoning Patients, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact minfei yang (+86 13757118252, 2200056@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.