Efficacy of Banhasasim-tang on Functional Dyspepsia

Korea Health Industry Development Institute

Status and phase: Completed; Phase 4

Conditions: Functional Dyspepsia

Treatments: Dietary Supplement: Corn-starch granules; Dietary Supplement: Banhasasim-tang

Study type: Interventional

Funder types: Other

Identifiers

NCT00987805

B090029

ISRCTN51910678 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to assess efficacy based on Gastrointestinal Symptom score and safety based on the rate of adverse event or laboratory findings of Banhasasim-tang administrated three times a day orally on functional dyspepsia.

Full description

Banhasasim-tang

1. Main 3 gram herb powder (including Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma) of old oriental prescriptions for dyspepsia.
2. Usually having used for dyspepsia in asia
3. Need for correct clinical information by RCT

Enrollment: 84 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Typical functional dyspepsia according to ROME III criteria.

   • One or more of:

     • Bothersome post-prandial fullness
     • Early satiation
     • Epigastric pain
     • Epigastric burning

   • No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms

2. The presence of 'moderate' as the degree of severity for at least three Gastrointestinal Symptom (GIS) score symptoms

3. Before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks

4. Written and informed consent

Exclusion criteria

1. History of peptic ulcer or gastroesophageal reflux disease(GERD)

2. Current prominent symptoms of irritable bowel syndrome or GERD

3. Presence of the following alarm symptoms:

   • Severe weight loss
   • Black or tar stool
   • Dysphagia

4. Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders

5. Women in pregnancy and lactation

6. History of gastrointestinal surgery or taking any drugs that may significantly alter digestive system

7. Participation of other clinical trials within the last 3 months

8. Severe mental problems or drug abuse

9. Judged by expert that they are appropriate to participate in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups, including a placebo group

Banhasasim-tang

Experimental group

Treatment:

Dietary Supplement: Banhasasim-tang

Placebo drug

Placebo Comparator group

Description:

The placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula

Treatment:

Dietary Supplement: Corn-starch granules