Acupuncture for postprandial distress syndrome (PDS)

Acupuncture for postprandial distress syndrome (APDS): a pilot randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18135146

Enrollment

Registered

2016-07-07

Start date

2016-07-15

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial distress syndrome (PDS) Digestive System Postprandial distress syndrome (PDS)

Interventions

Participants will be randomly assigned to verum acupuncture at acupoints or minimal acupuncture at non-acupoints in a 1:1 ration Verum acupuncture group: Participants in the verum acu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years 2. Normal esophagogastroduodenoscopy results within a year 3. Not allowed drug: anti-secretory drugs, antacids, prokinetics, non-steroidal anti-inflammatory drugs and antidepressant drugs during the treatment period 4. No other treatments received during the study 5. Willing to sign written informed consent

Exclusion criteria

Exclusion criteria: 1. Presence of serious structural disease(disease of heart, lung, liver or kidney), malignant or mental disease 2. Signs of irritable bowel syndrome 3. Surgery related with the gastrointestinal tract 4. Severe coagulopathy 5. Drug or alcohol abuse 6. Pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Overall treatment effect (OTE) is measured using patient interviews using a Likert scale at baseline, once a week for the four week treatment period and then at 4, 8 and 16 weeks after first acupuncture.	—

Secondary

Measure	Time frame
1. Symptoms and global assessment of PDS patients are measured using a four-item questionnaire-asymptomatic (0 point), mild (1 point), moderate (2 points) or severe (3 points)-including eight symptoms: postprandial distension, early satiety, epigastric pain, epigastric burning, upper abdominal bloating, nausea. Assessment will be conducted at baseline, twice a week in treatment period and 8, 16 weeks after first acupuncture. 2. Quality of life is evaluated using the 25-item Nepean Dyspepsia Index (NDI) at baseline, 4, 8 and 16 weeks after first acupuncture 3. Severity of anxiety and depression will be graded using the Hospital Anxiety Depression Scale (HADS) at baseline, 4, 8 and 16 weeks after first acupuncture	—

Measure

Time frame

1. Symptoms and global assessment of PDS patients are measured using a four-item questionnaire-asymptomatic (0 point), mild (1 point), moderate (2 points) or severe (3 points)-including eight symptoms: postprandial distension, early satiety, epigastric pain, epigastric burning, upper abdominal bloating, nausea. Assessment will be conducted at baseline, twice a week in treatment period and 8, 16 weeks after first acupuncture. 2. Quality of life is evaluated using the 25-item Nepean Dyspepsia Index (NDI) at baseline, 4, 8 and 16 weeks after first acupuncture 3. Severity of anxiety and depression will be graded using the Hospital Anxiety Depression Scale (HADS) at baseline, 4, 8 and 16 weeks after first acupuncture

—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026