AHW: Hot Water Drinking Therapy in Achalasia

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01863966
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 69
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Achalasia	Other: hot water drinking therapy; Procedure: Pneumatic dilation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients
• Study Start Date: Mar 1, 2010
• Anticipated Primary Completion Date: Nov 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline achalasia symptom score at 1 month [baseline and 1 month]

   Dysphagia, Regurgitation and Chest Pain scores

Secondary Outcome Measures

1. Number of patients with adverse effects [Week 1]

   adverse effects of drinking water like distention, nausea and belching

2. Change from baseline in barium esophagram at 1 year [baseline and 1 year]

   measure esophageal diameter

3. Endoscopy at 1 year [year 1]

   esophageal bezoars and esophageal cancer

4. Pneumatic dilation rate and relative efficacy [any time]

   Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation

5. Change from baseline in achalasia symptom score at 1 year [baseline and 1 year]

   Dysphagia,Regurgitation and Chest Pain scores

6. Change from baseline achalasia symptom scores at 5 years [baseline and 5 years]

   Dysphagia,Regurgitation and Chest Pain scores

7. Change from baseline in barium esophagram at 5 years [baseline and 5 years]

   measure esophageal diameter

8. Endoscopy at 5 years [year 5]

   esophageal bezoars and esophageal cancer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science	Beijing		China	100730

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT01863966
• Other Study ID Numbers: PUMCH-AchaWater
• First Posted: May 29, 2013
• Last Update Posted: May 29, 2013
• Last Verified: May 1, 2013

• Keywords provided by Peking Union Medical College Hospital: Achalasia; Hot water drinking therapy; Pneumatic dilation
• Additional relevant MeSH terms: Esophageal Achalasia

Study Results

No Results Posted as of May 29, 2013