The efficacy of curcuminoid in patients with overlapping gastroesophageal reflux disease and functional dyspepsia: A randomized controlled trial.

Phase 2

Active, not recruiting

• Conditions: 1. Gastroesophageal reflux disease (GERD)2. functional dyspepsia; curcuminoid; gastroesophageal reflux; gastric emptying; gastric accommodation

• Registration Number: TCTR20180530003
• Lead Sponsor: Government Pharmaceutical Organization (GPO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-30
• Study Completion: 2019-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Diagnosis criteria for acid reflux disease are:
1. Age 18 - 70 years
2. Patients with burning sensation or tightness in the chest. And / or have food Stomach back up in the esophagus and / or sour or bitter. These symptoms interfere with the quality of life.
Functional dyspepsia ROME IV criteria30 means patients with at least one of the following symptoms:
- Bothersome postpradial fullness
- Early satiety
- Epigastric pain
- Epigastriac burning pain
Symptoms Continued at least 3 months and started onset for at least 6 months.
3. Upper gastrointestinal endoscopy for 6 months prior to study.

Exclusion Criteria

1. Surgery in the abdomen except appendicitis, Maternity leave

2. Cancer of the gastrointestinal tract and liver

3. chronic inflammatory bowel disease inflammatory bowel disease

4. Cirrhosis, Chronic kidney disease

5. Depression

6. Upper gastrointestinal endoscopy results in 6 months before admission. The following abnormalities were observed: esophagus, gastric ulcer and duodenal ulcer.

7. Helicobacter pylori infection

8. Patients who take the drug with gastrointestinal effects and can not off the drug during research.

9. There are neurological diseases that can not be evaluated for pain. Uncontrolled psychiatric disorders and may want to adjust the drugs during study.

10. Have allergic curcumin.

11. Eat foods that component curcumin, regularly at least 3 days a week during the 1 month prior to study

12. Patients who can not sign the consent form for study participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient with GERD and functional dyspepsia responds to curcuminoid After 4 weeks of tintervention gastric accommodation and gastric emptying study,Relationship between treatment response and physiological changes of esophagus and stomach 4 weeks include lag time, gastric emptying half time, blood tests (TNFα, IL1β)

Secondary Outcome Measures

Name	Time	Method
Relationship between treatment response and physiological changes of gastroesophageal reflux disease After 4 weeks of intervention gastric accommodation and gastric emptying study,Changes in quality of life after taking curcuminoids and placebo. After 4 weeks of tinterventio Quality of Life Questionnaire Pre-Post, Weekly Symptoms Questionnaire, ,Side Effects of taking Curcuminoids and Placebo After 4 weeks of intervention gastric accommodation and gastric emptying study