Hot Water Drinking Therapy in Achalasia (AHW)

May 23, 2013 updated by: Peking Union Medical College Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. 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.
  2. Patients are followed by achalasia associated symptom scores, barium esophagram and endoscopy.
  3. If patients are unsatisfied with hot water drinking therapy, they receive pneumatic dilation

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science
        • Contact:
        • Principal Investigator:
          • Yutang Ren, M.D.
        • Principal Investigator:
          • Meiyun Ke, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • achalasia patients diagnosed by endoscopy, barium esophagram and manometry

Exclusion Criteria:

  • could not drink water
  • poor compliance
  • severe comorbidities
  • esophageal stenosis secondary to erosions and cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hot water drinking therapy
Hot water drinking before,after meal and before sleep
Other: hot water drinking therapy
Drink 200ml hot water 3min before and after a meal. Swallow food with hot water and drink 200ml hot water before sleep
ACTIVE_COMPARATOR: Pneumatic dilation
Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation
Procedure: Pneumatic dilation
Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation under endoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline achalasia symptom score at 1 month
Time Frame: baseline and 1 month
Dysphagia, Regurgitation and Chest Pain scores
baseline and 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse effects
Time Frame: Week 1
adverse effects of drinking water like distention, nausea and belching
Week 1
Change from baseline in barium esophagram at 1 year
Time Frame: baseline and 1 year
measure esophageal diameter
baseline and 1 year
Endoscopy at 1 year
Time Frame: year 1
esophageal bezoars and esophageal cancer
year 1
Pneumatic dilation rate and relative efficacy
Time Frame: any time
Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation
any time
Change from baseline in achalasia symptom score at 1 year
Time Frame: baseline and 1 year
Dysphagia,Regurgitation and Chest Pain scores
baseline and 1 year
Change from baseline achalasia symptom scores at 5 years
Time Frame: baseline and 5 years
Dysphagia,Regurgitation and Chest Pain scores
baseline and 5 years
Change from baseline in barium esophagram at 5 years
Time Frame: baseline and 5 years
measure esophageal diameter
baseline and 5 years
Endoscopy at 5 years
Time Frame: year 5
esophageal bezoars and esophageal cancer
year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Director: Meiyun Ke, M.D., Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ANTICIPATED)

November 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (ESTIMATE)

May 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-AchaWater

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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