CompletedNot Applicable

Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases

China360 participantsStarted 2017-07-10

Plain-language summary

This trial aims to determine whether Jiangzhong Hou Gu® Mi Xi™ is an effective intervention to improve symptoms and indicators in patients with spleen qi deficiency and peptic ulcer diseases.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Patient should be diagnosed as gastric or duodenal ulcer under endoscope; the diameter of ulcers range from 0.3 to 1.0 cm; no indicator of bleeding or perforation.
✓. Patient should be diagnosed as syndrome of spleen qi deficiency, that is, meet 2 main symptoms of spleen deficiency and 2 main symptoms of qi deficiency, or have 2 main symptoms of spleen deficiency, 1 main symptoms of qi deficiency and tongue symptoms as follow:
✓. Age is between 18 to 70 years
✓. Sign the informed consent

Exclusion criteria

✕. Patients who have complex peptic ulcer (i.e. have gastric and duodenal ulcer meanwhile)
✕. Patients who have history of ulcer complications (e.g. bleeding or perforation)
✕. Patients who have indicators of ulcer complications, including bleeding (Forrest stage I, IIa and IIb) or perforation (area of ulcer is more than 1 cm).
✕. Patients whose ulcer have healed, that is, the ulcer is at healing stage or scarring stage according to the diagnosis criteria in Consensus View of Integrated Chinese and Western Medicine on Diagnosis and Treatment of Peptic Ulcer (2011, Tianjin)
✕. Patients who took proton-pump inhibitor more than 3 days within 15 days, or took non-steroid anti-inflammatory drugs for a long term
✕. Female patients who are pregnant or breast-feeding, or prepare to pregnant for pregnancy within 2 years
✕. Patients who are allergic to sample or sample composition
✕. Patients who are allergic to sample or sample composition

What they're measuring

Total effective rate

Timeframe: At baseline, and 12, 26, 52, and 104 weeks

Quality of ulcer healing

Timeframe: At baseline and 12 and 26 weeks

Changes in Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (unit: score on a scale)

Timeframe: At basline and 6, 12, 26, 52 and 104 weeks

Trial details

NCT IDNCT03320538

SponsorJiangxi University of Traditional Chinese Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-17

View on ClinicalTrials.gov More Peptic Ulcer Disease trials