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Efficacy and safety of the Jin-yin-li-dan granules in patients with chronic cholecystitis (liver-gallbladder dampness-heat syndrome): A multicenter, double-blind, randomized, placebo-controlled, dose-escalation trial

Efficacy and safety of the Jin-yin-li-dan granules in patients with chronic cholecystitis (liver-gallbladder dampness-heat syndrome): A multicenter, double-blind, randomized, placebo-controlled, dose-escalation trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005375
Enrollment
Unknown
Registered
2014-10-21
Start date
2012-07-31
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 (liver-gallbladder dampness-heat syndrome)

Interventions

high dosage group:high dosage of Jin-yin-li-dan granules
middle dosage group:middle dosage of Jin-yin-li-dan granules
low dosage group:low dosage of Jin-yin-li-dan granules
placebo group :placebo of Jin-yin-li-dan granules

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Aged between 18 to 65 years with a confirmed diagnosis of chronic cholecystitis (liver-gallbladder dampness-heat syndrome) and informed consent was obtained from all patients or their legal representatives prior to randomization.

Exclusion criteria

Exclusion criteria: (1) acute cholecystitis including simple, purulent and gangrenous cholecystitis;biliary obstructive disease, acute obstructive suppurative cholangitis, gallbladder perforation complicated with diffuse peritonitis; (2) T heigher than 37.5 degree, WBC more than 11*10^9/L, Neu more than 80%; (3) With the intention of pregnant, pregnant or lactating women; (4) With the intention of surgery in 4 months; (5) With severe primary diseases of the heart, liver, kidney, blood system and endocrinium, such as tumour or AIDS; diabetes; psychotics; abnormal renal function (Scr); urine protein more than positive; AST, ALT more than 1.5 times of the high normal range; abnormal ECG; WBC less than 3.0*10^9/L; (6) Patients participated in other clinical trials within three months; (7) Allergic constitution or allergic to this drug or to the known composition of placebo; (8) Patients are doubt or do have the abuse history of alcohol or drug; (9) Poor compliant patients; (10) Patients with disabilities (blind, deaf, dumb, dysgnosia, dysphrenia, physical disabilities).

Design outcomes

Primary

MeasureTime frame
VAS of main symptom;cumulative traditional Chinese medicine syndrome score;colour doppler ultrasound efficacy;recurrence rate and frequency;

Secondary

MeasureTime frame
security evaluation indexes;

Countries

China

Contacts

Public ContactXiao-Nan Yang
yangxxnan@163.com+86 18980602123

Outcome results

None listed

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