Hot Water Drinking Therapy in Achalasia
AHW
Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 29, 2013
May 1, 2013
5.7 years
May 21, 2013
May 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline achalasia symptom score at 1 month
Dysphagia, Regurgitation and Chest Pain scores
baseline and 1 month
Secondary Outcomes (8)
Number of patients with adverse effects
Week 1
Change from baseline in barium esophagram at 1 year
baseline and 1 year
Endoscopy at 1 year
year 1
Pneumatic dilation rate and relative efficacy
any time
Change from baseline in achalasia symptom score at 1 year
baseline and 1 year
- +3 more secondary outcomes
Study Arms (2)
Hot water drinking therapy
EXPERIMENTALHot water drinking before,after meal and before sleep
Pneumatic dilation
ACTIVE COMPARATORPatients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation
Interventions
Drink 200ml hot water 3min before and after a meal. Swallow food with hot water and drink 200ml hot water before sleep
Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation under endoscope
Eligibility Criteria
You may qualify if:
- achalasia patients diagnosed by endoscopy, barium esophagram and manometry
You may not qualify if:
- could not drink water
- poor compliance
- severe comorbidities
- esophageal stenosis secondary to erosions and cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science
Beijing, 100730, China
Related Publications (2)
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.
PMID: 9649001RESULTRen 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.
PMID: 23105999RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Meiyun Ke, M.D.
Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2013
First Posted
May 29, 2013
Study Start
March 1, 2010
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
May 29, 2013
Record last verified: 2013-05