AchalasiaAHWNCT01863966
Hot Water Drinking Therapy in Achalasia
A study testing hot water drinking therapy and Pneumatic dilation in people with Achalasia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
From clinical observation that some achalasia patients drink water to help swallow food, the investigators have proposed a systemic hot water drinking therapy. This study is to observe its efficacy on achalasia symptoms and explore its mechanism. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achalasia
- What is being tested?
- hot water drinking therapy and Pneumatic dilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Dec 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- achalasia patients diagnosed by endoscopy, barium esophagram and manometry
Who cannot join
- could not drink water
- poor compliance
- severe comorbidities
- esophageal stenosis secondary to erosions and cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science
Beijing, 100730
Meiyun Ke, M.D., +86-10-69155006, Kemypumch2006@yahoo.com.cn
Yutang Ren, M.D.
About this study
Official title: Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients
From clinical observation that some achalasia patients drink water to help swallow food, the investigators have proposed a systemic hot water drinking therapy. This study is to observe its efficacy on achalasia symptoms and explore its mechanism.
Read the detailed description
- Achalasia patients will participate hot water drinking therapy: to drink 200ml of hot water before and after a meal, as well as 2 hours before sleep and to chew food carefully and swallow with hot soup.
- Patients are followed by achalasia associated symptom scores, barium esophagram and endoscopy.
- If patients are unsatisfied with hot water drinking therapy, they receive pneumatic dilation
- Conditions
- Achalasia
- Being tested
- hot water drinking therapy, Pneumatic dilation
- Keywords
- Achalasia, Hot water drinking therapy, Pneumatic dilation
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hot water drinking therapyOther
Drink 200ml hot water 3min before and after a meal. Swallow food with hot water and drink 200ml hot water before sleep
Pneumatic dilationProcedure or surgery
Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation under endoscope
| Study group | Role | What they receive |
|---|---|---|
| Hot water drinking therapy | Experimental | Hot water drinking before,after meal and before sleep Receives: Other: hot water drinking therapy |
| Pneumatic dilation | Active comparator | Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation Receives: Procedure: Pneumatic dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline achalasia symptom score at 1 month
Dysphagia, Regurgitation and Chest Pain scores
Measured: baseline and 1 month
Secondary outcomes (8)
Number of patients with adverse effects
adverse effects of drinking water like distention, nausea and belching
Measured: Week 1
Change from baseline in barium esophagram at 1 year
measure esophageal diameter
Measured: baseline and 1 year
Endoscopy at 1 year
esophageal bezoars and esophageal cancer
Measured: year 1
Pneumatic dilation rate and relative efficacy
Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation
Measured: any time
Change from baseline in achalasia symptom score at 1 year
Dysphagia,Regurgitation and Chest Pain scores
Measured: baseline and 1 year
Change from baseline achalasia symptom scores at 5 years
Dysphagia,Regurgitation and Chest Pain scores
Measured: baseline and 5 years
Change from baseline in barium esophagram at 5 years
measure esophageal diameter
Measured: baseline and 5 years
Endoscopy at 5 years
esophageal bezoars and esophageal cancer
Measured: year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMar 2010
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meiyun Ke, M.D., Study director, Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863966
- Sponsor's protocol ID
- PUMCH-AchaWater
- Acronym
- AHW
- Status last verified
- May 2013
- First submitted
- 21 May 2013
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Triadafilopoulos G, Tsang HP, Segall GM. Hot water swallows improve symptoms and accelerate esophageal clearance in esophageal motility disorders. J Clin Gastroenterol. 1998 Jun;26(4):239-44. doi: 10.1097/00004836-199806000-00003.
PubMed 9649001Ren Y, Ke M, Fang X, Zhu L, Sun X, Wang Z, Wang R, Wei Z, Wen P, Xin H, Chang M. Response of esophagus to high and low temperatures in patients with achalasia. J Neurogastroenterol Motil. 2012 Oct;18(4):391-8. doi: 10.5056/jnm.2012.18.4.391. Epub 2012 Oct 9.
PubMed 23105999
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients
- ClinicalTrials.gov ID
- NCT01863966
- Acronym / sponsor ID
- AHW / PUMCH-AchaWater
- Conditions
- Achalasia
- Keywords
- Achalasia, Hot water drinking therapy, Pneumatic dilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 May 2013 (estimated)
- 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.
From clinical observation that some achalasia patients drink water to help swallow food, the investigators have proposed a systemic hot water drinking therapy. This study is to observe its efficacy on achalasia symptoms and explore its mechanism.
Detailed description
- Achalasia patients will participate hot water drinking therapy: to drink 200ml of hot water before and after a meal, as well as 2 hours before sleep and to chew food carefully and swallow with hot soup.
- Patients are followed by achalasia associated symptom scores, barium esophagram and endoscopy.
- If patients are unsatisfied with hot water drinking therapy, they receive pneumatic dilation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot water drinking therapy | Experimental | Other: hot water drinking therapyHot water drinking before,after meal and before sleep |
| Pneumatic dilation | Active comparator | Procedure: Pneumatic dilationPatients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- achalasia patients diagnosed by endoscopy, barium esophagram and manometry
Key exclusion criteria (4 listed)
- could not drink water
- poor compliance
- severe comorbidities
- esophageal stenosis secondary to erosions and cancer
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 |
|---|---|---|
| hot water drinking therapyDrink 200ml hot water 3min before and after a meal. Swallow food with hot water and drink 200ml hot water before sleep | Other | Hot water drinking therapy |
| Pneumatic dilationPatients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation under endoscope | Procedure or surgery | Pneumatic dilation |
Primary outcome
Change from baseline achalasia symptom score at 1 month
Time frame: baseline and 1 month
Dysphagia, Regurgitation and Chest Pain scores
8 secondary outcomes
Number of patients with adverse effects
Time frame: Week 1
Change from baseline in barium esophagram at 1 year
Time frame: baseline and 1 year
Endoscopy at 1 year
Time frame: year 1
Pneumatic dilation rate and relative efficacy
Time frame: any time
Change from baseline in achalasia symptom score at 1 year
Time frame: baseline and 1 year
Change from baseline achalasia symptom scores at 5 years
Time frame: baseline and 5 years
Change from baseline in barium esophagram at 5 years
Time frame: baseline and 5 years
Endoscopy at 5 years
Time frame: year 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
- Results publication: PubMed 9649001Triadafilopoulos G, Tsang HP, Segall GM. Hot water swallows improve symptoms and accelerate esophageal clearance in esophageal motility disorders. J Clin Gastroenterol. 1998 Jun;26(4):239-44. doi: 10.1097/00004836-199806000-00003.
- Results publication: PubMed 23105999Ren Y, Ke M, Fang X, Zhu L, Sun X, Wang Z, Wang R, Wei Z, Wen P, Xin H, Chang M. Response of esophagus to high and low temperatures in patients with achalasia. J Neurogastroenterol Motil. 2012 Oct;18(4):391-8. doi: 10.5056/jnm.2012.18.4.391. Epub 2012 Oct 9.
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Achalasia
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.
Meiyun Ke, M.D. study director
Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hot water drinking therapy and Pneumatic dilation in people with Achalasia, run by Peking Union Medical College Hospital 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 1 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 29 May 2013. 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 Yutang Ren, M.D. (+86-020-62786224, renytpumc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline achalasia symptom score at 1 month (time frame: baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863966, which also lists 2 linked publications.
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 29 May 2013.