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A Multicenter randomized folic acid-controlled clinical trial of traditional Chinese herbal medicine and Moluo Dan in the treatment of gastric precancerous lesion

Study on early diagnosis and early intervention of gastric precancerous lesion

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000169
Enrollment
Unknown
Registered
2008-10-03
Start date
2007-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Gastric precancerous lesion (gastric epithelial dysplasia of mild or moderate degree at the base of chronic atrophic gastritis)

Interventions

Group C:Moluo Dan, 9g, taken orally, Tid
Group A:Folic acid, 5mg, taken orally, Tid
Group B:TCM "Bianzhen", 100-150ml once orally, Tid

Sponsors

Xiyuan Hospital, Chinese Academy of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Outpatient or inpatient fulfilling the diagnosis of gastric precancerous lesion by gastro-endoscopy and histopathology; 2. Fulfilling the traditional Chinese medicine diagnosis of liver-stomach disharmony syndrome, stomach-yin insufficiency syndrome, spleen-stomach damp-heat syndrome, qi stagnation and spleen deficiency syndrome; 3. Age of 18–70, both males and females; 4. With informed written consent.

Exclusion criteria

Exclusion criteria: 1. Gastric epithelial dysplasia of severe degree; 2. Previous history of gastrectomy; 3. Long-term administration of non-steroidal anti-inflammatory drug (NSAIDs); 4. Suggestive of gastric cancer or malignant lesion of other systems; 5. Severe systemic diseases, like cardio-cerebral-vascular disease, hepatic diseases, Blood System Diseases, and etc; 6. Psychosis patient, dementia, intelligence or language disorder incapable of adequatecooperation; 7. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Incidence rate of gastric cancer;Histopathological score of gastric mucos;

Secondary

MeasureTime frame
Mucosal lesion score under endoscopy;Symptom score;Score of Patient reported outcome instrumen;

Countries

China

Contacts

Public ContactXudong Tang
txdly@sina.com.cn+86 010 62882399

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026