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Sanjiu weitai granules in treatment of non-atrophic gastritis: a multi-center, randomized, double-blind, double-dummy, positive drug and placebo controlled clinical study

Sanjiu weitai granules in treatment of non-atrophic gastritis: a multi-center, randomized, double-blind, double-dummy, positive drug and placebo controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001316
Enrollment
Unknown
Registered
2011-05-01
Start date
2011-06-01
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

non-atrophic gastritis(=chronic superficial gastritis)(CSG)

Interventions

Placebo-controlled group:Sanjiu weitai granules placebo,2.5g,bid]+[Teprenone Capsules placebo,50mg,tid]
Positive drug controlled group:Sanjiu weitai granules placebo,2.5g,bid]+[Teprenone Capsules placebo,50mg,tid]
Experimental group:[Sanjiu weitai granules,2.5g,bid]+[Teprenone Capsules placebo,50mg,tid]

Sponsors

Xiyuan Hospital Affiliated to China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 .Male and female aged 18 to 70 years old. 2. fulfill the diagnostic criteria of non-atrophic gastritis in Western Medicine,and meet at least one of the following: (1) erythema ranked as grade 2 and above; (2) with erosive; (3) with mucous membrane bleeding. 3. fulfill the diagnostic criteria of TCM syndrome patterns as follows: syndrome of dampnessheat of spleen and stomach,syndrome of incoordination beteeen liver and stomach,syndrome of deficiency of stomach yin, syndrome of deficiency of stomach and spleen qi, syndrome of static blood in stomach collaterals,syndrome of deficient cold of spleen and stomach; 4. sign the informed consent and will to accept corresponding intervention; 5. have the ability of reading power.

Exclusion criteria

Exclusion criteria: 1. merge with diseases of active peptic ulcer,gastritis with active bleeding,severe dysplasia or suspected malignancy of the gastric mucosa; 2. diagnosed atrophic gastritis by pathology; 3. a history of gastric surgery; 4. long-term use of hormones, NSAIDs; 5. have used treatment medicines of the disease in the nearly two weeks after the onset of the disease and do not allow entering a 2-week drug washout period because of the disease condition or individuals unwilling; 6. has a serious primary cardiovascular disease, liver disease, kidney disease, hematologic disease, lung disease, or other serious diseases affected the survival, such as cancer or AIDS; 7. mental illness and intellectual, language disabilities; 8. pregnant or lactating women; 9. be allergy to the drug composition used in the trial; 10. patients who is participating or participated in last 4 weeks in other drug clinical trials; 11. suspected or indeed alcohol or drug abuse history, or possibility of easily being lost according to the researchers' determination.

Design outcomes

Primary

MeasureTime frame
Mucosal lesion score under endoscopy;

Secondary

MeasureTime frame
Symptom score;Score of Patient reported outcome instrument;

Countries

China

Contacts

Public ContactXudong Tang
txdly@sina.com+86 10 62835001

Outcome results

None listed

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