Clinical Trial: Hot Water Drinking Therapy in Achalasia
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients
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.
Detailed Summary:
- 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
Sponsor: Peking Union Medical College Hospital
Current Primary Outcome: Change from baseline achalasia symptom score at 1 month [ Time Frame: baseline and 1 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of patients with adverse effects [ Time Frame: Week 1 ]adverse effects of drinking water like distention, nausea and belching
- Change from baseline in barium esophagram at 1 year [ Time Frame: baseline and 1 year ]measure esophageal diameter
- Endoscopy at 1 year [ Time Frame: year 1 ]esophageal bezoars and esophageal cancer
- Pneumatic dilation rate and relative efficacy [ Time Frame: any time ]Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation
- Change from baseline in achalasia symptom score at 1 year [ Time Frame: baseline and 1 year ]Dysphagia,Regurgitation and Chest Pain scores
- Change from baseline achalasia symptom scores at 5 years [ Time Frame: baseline and 5 years ]Dysphagia,Regurgitation and Chest Pain scores
- Change from baseline in barium esophagram at 5 years [ Time Frame: baseline and 5 years ]measure esophageal diameter
- Endoscopy at 5 years [ Time Frame: year 5 ]esophageal bezoars and esophageal cancer
Original Secondary Outcome: Same as current
Information By: Peking Union Medical College Hospital
Dates:
Date Received: May 21, 2013
Date Started: March 2010
Date Completion: December 2015
Last Updated: May 23, 2013
Last Verified: May 2013