GB34 Acupuncture in Acute Cholecystitis

January 6, 2026 updated by: Alirıza Erdoğan, Nigde Omer Halisdemir University

GB34 Acupuncture as Adjuvant in Early Phase of Medical Treatment of Mild Acute Cholecystitis

The purpose of this pilot study is to investigate the effects of GB34 acupuncture, performed as adjuvant to standard medical treatment, on clinical response and laboratory parameters of patients with a diagnosis of acute cholecystitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute cholecystitis is a frequent complication of gallbladder stones. The prevalence of gallbladder stone is 10-15% and in 35% of patients complications and recurrent symptoms develop in their lifetime. Acute cholecystitis is one of the most frequently encountered acute surgical conditions. It is manifested in 3-10% of patients referred to emergency departments with complaints of abdominal pain.

Although the gold standard of therapy is laparoscopic cholecystectomy in symptomatic cholecystitis and related complications, more than 70% of patients respond well to medical treatment at first place. Actually, timing of cholecystectomy was studied extensively, yet is still debatable. Early cholecystectomy is the operation performed within 72 hours of the beginning of the symptoms. Delayed cholecystectomy is the operation performed 6 weeks after the suppression of the inflammation. Investigators perform early cholecystectomy is in cases with perforation and complication like gangrenous or emphysematous acute cholecystitis whereas delayed cholecystectomy is preferred in the remaining patients.

In fact it is known for some time that ear and body acupuncture have modulatory effects on motor functions of gallbladder and even provide some improvement in acute cholecystitis. Previously, studies demonstrating that GB34 has specific effects on the motility of bile ducts were published. More recently, researchers were able to demonstrate that GB34 electro acupuncture have positive effects on gall bladder wall thickness and on WBC levels, by using an experimental rabbit model of acute cholecystitis. Additional functional MR studies were used to distinguish the neural specificity of the acupuncture points. GB34 were found to induce a specific response pattern which is more significant in motor functions in brain. Furthermore it is known for decades that acupuncture other than point specific effects, triggers self-healing mechanisms of the body via endogen pathways.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Niğde, Turkey (Türkiye)
        • Niğde Ömer Halisdemir University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed and hospitalised patients with mild acute cholecystitis

Exclusion Criteria:

  • Pregnant women
  • Immunosuppressive patients
  • Patients with intermediate and severe acute cholecystitis
  • Patients with acalculous acute cholecystitis
  • Patients with uncontrolled diabetes mellitus
  • Patients with collegen tissue diseases
  • Patients with malignancies
  • Patients who are using anti-coagulant or anti-aggregant medications
  • Patients with blood diseases
  • Patients with BMI>35

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
GB34 acupuncture will be applied every day. Patients will receive standard medical treatment
Procedure: Acupuncture
Acupuncture will be performed bilateral on fibular aspect of the leg, in the depression anterior and distal to the head of the fibula by using 0,25x50mm needles.
No Intervention: Controls
Patients will only receive standard medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived pain
Time Frame: From hospital admission (baseline) until hospital discharge, with VAS assessments performed every 12 hours, assessed up to a maximum of 168 hours.
Measured by Visual Analog Scale scored between 0 and 10. Zero refers to no pain whereas 10 refers to the worst pain perceived by the patient.
From hospital admission (baseline) until hospital discharge, with VAS assessments performed every 12 hours, assessed up to a maximum of 168 hours.
Analgesic dosage
Time Frame: From hospital admission (baseline) until hospital discharge, assessed up to a maximum of 168 hours.
Total dosage of analgesic administered in mg
From hospital admission (baseline) until hospital discharge, assessed up to a maximum of 168 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Guarding
Time Frame: At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.
presence or absence of abdominal guarding assessed by investigators. Guarding is defined as a spasm of muscles that minimizes the motion or agitation of sites that are affected by injury or disease.
At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.
Abdominal tenderness
Time Frame: At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.
presence or absence of abdominal tenderness assessed by investigators. Rebound tenderness refers to pain or discomfort after pressing on the patient's abdomen .
At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.
Oral intake
Time Frame: From hospital admission (baseline) until first tolerated oral intake, assessed up to hospital discharge (maximum 168 hours).
if patients tolerate oral intake or not
From hospital admission (baseline) until first tolerated oral intake, assessed up to hospital discharge (maximum 168 hours).
Antibiotic dosage
Time Frame: From hospital admission (baseline) through hospital discharge, assessed up to a maximum of 168 hours
Total antibiotic dose administered during hospitalization (mg)
From hospital admission (baseline) through hospital discharge, assessed up to a maximum of 168 hours
Direct bilirubin
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Direct bilirubin levels expressed in mg/dL
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Total bilirubin
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Total bilirubin levels expressed in mg/dL
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Amylase
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Amylase levels expressed in U/L
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
GGT
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Gamma glutamyl transferase levels expressed in U/L
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
ALP
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Alkaline phosphatase levels expressed in U/L
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
ALT
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Alanine aminotransferase levels expressed in U/L
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
AST
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Aspartate aminotransferase levels expressed in IU/L
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
CRP
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
C-reactive protein levels expressed in mg/L
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
PLT
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
platelet count in microliter
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
LYM%
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
percent of lymphocytes
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
NEU%
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
percent of neutrophils
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
WBC
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
White blood cell count in microliter
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Hb
Time Frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Hemoglobin values expressed as g/dL
At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nigde Omer Halisdemir University

Investigators

  • Principal Investigator: Alirıza Erdoğan, MD, Nigde Omer Halisdemir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

December 10, 2025

Study Completion (Actual)

December 10, 2025

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 10, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Estimated)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08.06.2021/32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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