Treatment of chronic cholecystitis (dampness-heat syndrome) with the Yi-Ke-Ding Tablets: A multicenter, phase III, randomized, double-blind, double-dummy and parallel-group trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-14005428

Enrollment

Unknown

Registered

2014-11-02

Start date

2010-11-15

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

chronic cholecystitis

Interventions

Positive control group:Fu-Fang-Dan-Tong tables + Dummy Yi-Ke-Ding tables

Placebo control group:Dummy Yi-Ke-Ding tables + Dummy Fu-Fang-Dan-Tong tables

Experimental group :Yi-Ke-Ding tables + Dummy Fu-Fang-Dan-Tong tables

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Voluntary provision of written informed consent prior to enrollment; (2) Diagnosis of chronic cholecystitis according to Western medicine; (3) Diagnosis of dampness-heat syndrome, according to the TCM syndrome differentiation;(4) Aged between 18 and 65 years.

Exclusion criteria

Exclusion criteria: (1) Diagnosis of acute simple cholecystitis, cholangiolithiasis, acute pyogenic cholecystitis, acute gangrenous cholecystitis, acute obstructive suppurative cholangitis, gallbladder perforation complicated with diffuse peritonitis; (2) Patient's temperature higher than at least 37.5 degree, blood leukocyte count more than 11*10^9/L or neutrophil percentage more than 80%; (3) Female patients preparing for a baby, pregnant or lactation women; (4) Combined with serious comorbidities of heart, liver, kidney blood or endocrine system (such as diabetes mellitus, creatinine (Cr) greater than the upper limit of normal urine protein positive reaction more than (+), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal, abnormal electrocardiogram with clinical significance blood leukocyte count less than 3.0*10^9/L and so on) or having psychiatric disorders, tumor or AIDS; (5) Participated or are participating in clinical trials by other drugs within the past three months; (6) Allergies or allergic to the known ingredient of the test drug; (7) Suspected or proved a history of alcohol or drug abuse; (8) Poor compliance during the trial judged by investigators.

Design outcomes

Primary

Measure	Time frame
VAS score of the right hypochondriac pain;	—

Secondary

Measure	Time frame
The treatment efficacy in the Chinese medicine field;The efficacy evaluated by ultrasonograthy;	—

Countries

China

Contacts

Public ContactXiaonan Yang

yangxxnan@163.com+86 18980602123

Outcome results

None listed

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