GB34 Acupuncture in Acute Cholecystitis

NCT04960189 | Completed

• 1 other identifier: 08.06.2021/32
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Cholecystitis

Outcome Measures

Primary Outcomes (2)

• Perceived pain

  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

  Total dosage of analgesic administered in mg

  From hospital admission (baseline) until hospital discharge, assessed up to a maximum of 168 hours.

Secondary Outcomes (17)

• Guarding

  At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.

• Abdominal tenderness

  At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.

• Oral intake

  From hospital admission (baseline) until first tolerated oral intake, assessed up to hospital discharge (maximum 168 hours).

• Antibiotic dosage

  From hospital admission (baseline) through hospital discharge, assessed up to a maximum of 168 hours

• Direct bilirubin

  At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

Study Arms (2)

Acupuncture

EXPERIMENTAL

GB34 acupuncture will be applied every day. Patients will receive standard medical treatment

Procedure: Acupuncture

Controls

NO INTERVENTION

Patients will only receive standard medical treatment

Interventions

Acupuncture PROCEDURE

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.

Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed and hospitalised patients with mild acute cholecystitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir University Training and Research Hospital

Niğde, Turkey (Türkiye)

Location

Related Publications (6)

• Bouassida M, Zribi S, Krimi B, Laamiri G, Mroua B, Slama H, Mighri MM, M'saddak Azzouz M, Hamzaoui L, Touinsi H. C-reactive Protein Is the Best Biomarker to Predict Advanced Acute Cholecystitis and Conversion to Open Surgery. A Prospective Cohort Study of 556 Cases. J Gastrointest Surg. 2020 Dec;24(12):2766-2772. doi: 10.1007/s11605-019-04459-8. Epub 2019 Nov 25.

  PMID: 31768828 BACKGROUND

• Arer IM, Yabanoglu H, Caliskan K. Can red cell distribution width be used as a predictor of acute cholecystitis? Turk J Surg. 2017 Jun 1;33(2):76-79. doi: 10.5152/turkjsurg.2017.3392. eCollection 2017.

  PMID: 28740954 BACKGROUND

• Zhou ML, Jia WR, Wang JT, Wang P, Guo LH, Sui MH. [Effect of Electroacupuncture at "Yanglingquan" (GB 34) Acupoint on White Blood Cell Count and Gallbladder Wall Thickness in Rabbits with Acute Cholecystitis]. Zhen Ci Yan Jiu. 2015 Jun;40(3):233-7. Chinese.

  PMID: 26237977 BACKGROUND

• Yeo S, Choe IH, van den Noort M, Bosch P, Jahng GH, Rosen B, Kim SH, Lim S. Acupuncture on GB34 activates the precentral gyrus and prefrontal cortex in Parkinson's disease. BMC Complement Altern Med. 2014 Sep 15;14:336. doi: 10.1186/1472-6882-14-336.

  PMID: 25220656 BACKGROUND

• Na BJ, Jahng GH, Park SU, Jung WS, Moon SK, Park JM, Bae HS. An fMRI study of neuronal specificity of an acupoint: electroacupuncture stimulation of Yanglingquan (GB34) and its sham point. Neurosci Lett. 2009 Oct 16;464(1):1-5. doi: 10.1016/j.neulet.2009.08.009. Epub 2009 Aug 8.

  PMID: 19666085 BACKGROUND

• Andersson S, Lundeberg T. Acupuncture--from empiricism to science: functional background to acupuncture effects in pain and disease. Med Hypotheses. 1995 Sep;45(3):271-81. doi: 10.1016/0306-9877(95)90117-5.

  PMID: 8569551 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Alirıza Erdoğan, MD

  Niğde Ömer Halisdemir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 13, 2021
• Study Start: July 1, 2021
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)