NCT05749159

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

February 18, 2023

Last Update Submit

March 1, 2023

Conditions

Keywords

hiccup

Outcome Measures

Primary Outcomes (2)

  • the rate of termination of hiccup in 30 seconds

    the rate of termination of hiccup in 30 seconds

    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

    1 year

Study Arms (2)

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.

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.

Behavioral: physiotherapy

Interventions

physiotherapyBEHAVIORAL

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.

alternative therapyphysiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Able to swallow water

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Hiccup

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Shen Jian

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 1, 2023

Study Start

March 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations