HiccupHICCUPNCT05749159
New Physitherapy or Alternative Therapy for Hiccup
A study testing physiotherapy in people with Hiccup, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Hiccup is a common symptom, and it is currently believed that hiccups result from diaphragmatic spasm, with onset ranging from minutes to days. Some patients may terminate on their own, or by ways such as gasping. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiccup
- What is being tested?
- physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Able to swallow water
Who cannot join
- Allergy or contraindication to the following drugs: metoclopramide et al
- Severe choking on water and difficulty swallowing were present
- Impaired consciousness and inability to cooperate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Shen Jian, 13634134320, sjcardiology@163.com
About this study
Official title: Comparison of New pHysIotherapy With Alternative Therapy for Clinical outComes in Patients With hiccUP: Rationale and Design of a Randomized Clinical Trail
Hiccup is a common symptom, and it is currently believed that hiccups result from diaphragmatic spasm, with onset ranging from minutes to days. Some patients may terminate on their own, or by ways such as gasping. For some patients with duration longer than 1 day, even longer than 2 days, medications may be needed, mainly: metoclopramide, eperisone hydrochloride tablets, etc. Acupuncture is also effective for some patients. Surgical treatment may be required for some clinically intractable hiccups. However, for the above interventions or treatment means, the current efficacy still needs to be improved.
In the previous clinical experience, we create a new physical clinic protocol which could terminate the hiccup symptom onset instantaneously without adding extra cost to the patient, and the physiotherapy method was convenient and effective. To further validate the superiority, safety of this novel physical therapy regimen, we designed a randomised controlled, prospective, single centre clinical study aimed at comparing the efficacy and safety of the novel physical therapy with conventional pharmacotherapy in patients with hiccups.
- Conditions
- Hiccup
- Being tested
- physiotherapy
- Keywords
- hiccup
- Medical subject headings
- Hiccup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyBehavioural
New physical therapy: a disposable cup (soft cup) to take 1/3 cup of room temperature water and place it on a table. The patient takes a sitting or standing position. The middle finger of both hands press tightly against the nose to seal the nasal cavity. At the same time, press the ear screen with both hands to close the ear canal. After that, bite the cup with teeth (hands do not touch the cup), and drink up 1-2 mouthfuls of water.
| Study group | Role | What they receive |
|---|---|---|
| physiotherapy | Experimental | New physical therapy: a disposable cup (soft cup) to take 1/3 cup of room temperature water and place it on a table. The patient takes a sitting or standing position. The middle finger of both hands press tightly against the nose to seal the nasal cavity. At the same time, press the ear screen with both hands to close the ear canal. After that, bite the cup with teeth (hands do not touch the cup), and drink up 1-2 mouthfuls of water. Receives: Behavioral: physiotherapy |
| alternative therapy | Placebo comparator | Alternative therapy: including routine physical therapy such as suffocation and drinking cold water, as well as drug therapy such as metoclopramide and Mianna. Receives: Behavioral: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of termination of hiccup in 30 seconds
the rate of termination of hiccup in 30 seconds
Measured: 1 year
the time course from the start of therapy to the end of hicuup
the time course from the start of therapy to the end of hicuup
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HiccupStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shen Jian, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749159
- Sponsor's protocol ID
- 2023-0115
- Acronym
- HICCUP
- Status last verified
- Feb 2023
- First submitted
- 18 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of New pHysIotherapy With Alternative Therapy for Clinical outComes in Patients With hiccUP: Rationale and Design of a Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT05749159
- Acronym / sponsor ID
- HICCUP / 2023-0115
- Conditions
- Hiccup
- Keywords
- hiccup
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Mar 2023 (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.
Hiccup is a common symptom, and it is currently believed that hiccups result from diaphragmatic spasm, with onset ranging from minutes to days. Some patients may terminate on their own, or by ways such as gasping. For some patients with duration longer than 1 day, even longer than 2 days, medications may be needed, mainly: metoclopramide, eperisone hydrochloride tablets, etc. Acupuncture is also effective for some patients. Surgical treatment may be required for some clinically intractable hiccups. However, for the above interventions or treatment means, the current efficacy still needs to be improved.
In the previous clinical experience, we create a new physical clinic protocol which could terminate the hiccup symptom onset instantaneously without adding extra cost to the patient, and the physiotherapy method was convenient and effective. To further validate the superiority, safety of this novel physical therapy regimen, we designed a randomised controlled, prospective, single centre clinical study aimed at comparing the efficacy and safety of the novel physical therapy with conventional pharmacotherapy in patients with hiccups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physiotherapy | Experimental | Behavioral: physiotherapyNew physical therapy: a disposable cup (soft cup) to take 1/3 cup of room temperature water and place it on a table. The patient takes a sitting or standing position. The middle finger of both hands press tightly against the nose to seal the nasal cavity. At the same time, press the ear screen with both hands to close the ear canal. After that, bite the cup with teeth (hands do not touch the cup), and drink up 1-2 mouthfuls of water. |
| alternative therapy | Placebo comparator | Behavioral: physiotherapyAlternative therapy: including routine physical therapy such as suffocation and drinking cold water, as well as drug therapy such as metoclopramide and Mianna. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Able to swallow water
Key exclusion criteria (3 listed)
- Allergy or contraindication to the following drugs: metoclopramide et al
- Severe choking on water and difficulty swallowing were present
- Impaired consciousness and inability to cooperate
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 |
|---|---|---|
| physiotherapyNew physical therapy: a disposable cup (soft cup) to take 1/3 cup of room temperature water and place it on a table. The patient takes a sitting or standing position. The middle finger of both hands press tightly against the nose to seal the nasal cavity. At the same time, press the ear screen with both hands to close the ear canal. After that, bite the cup with teeth (hands do not touch the cup), and drink up 1-2 mouthfuls of water. | Behavioural | alternative therapy, physiotherapy |
Primary outcome
the rate of termination of hiccup in 30 seconds
Time frame: 1 year
the rate of termination of hiccup in 30 seconds
the time course from the start of therapy to the end of hicuup
Time frame: 1 year
the time course from the start of therapy to the end of hicuup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Hiccup
RecruitingObservational study
Hiccups and Obstacles Of E-Learning Among Medical Sudents
Covid-19, E-learning
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.
Shen Jian study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy in people with Hiccup, 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 2 inclusion and 3 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 3 Mar 2023. 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. Some participants in this study may receive a placebo. 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 Shen Jian (+86 13634134320, sjcardiology@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of termination of hiccup in 30 seconds (time frame: 1 year). The study lists 2 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 3 Mar 2023.