Acute CholecystitisNCT04960189
GB34 Acupuncture in Acute Cholecystitis
A study testing Acupuncture in people with Acute Cholecystitis, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed and hospitalised patients with mild acute cholecystitis
Who cannot join
- 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
Show all 10Show fewer
- Patients with malignancies
- Patients who are using anti-coagulant or anti-aggregant medications
- Patients with blood diseases
- Patients with BMI>35
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Niğde Ömer Halisdemir University Training and Research Hospital
Niğde
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Cholecystitis
- Being tested
- Acupuncture
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | GB34 acupuncture will be applied every day. Patients will receive standard medical treatment Receives: Procedure: Acupuncture |
| Controls | No intervention | Patients will only receive standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From hospital admission (baseline) until hospital discharge, assessed up to a maximum of 168 hours.
Secondary outcomes (17)
Guarding
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.
Measured: At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.
Abdominal tenderness
presence or absence of abdominal tenderness assessed by investigators. Rebound tenderness refers to pain or discomfort after pressing on the patient's abdomen .
Measured: At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.
Oral intake
if patients tolerate oral intake or not
Measured: From hospital admission (baseline) until first tolerated oral intake, assessed up to hospital discharge (maximum 168 hours).
Antibiotic dosage
Total antibiotic dose administered during hospitalization (mg)
Measured: From hospital admission (baseline) through hospital discharge, assessed up to a maximum of 168 hours
Direct bilirubin
Direct bilirubin levels expressed in mg/dL
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Total bilirubin
Total bilirubin levels expressed in mg/dL
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Amylase
Amylase levels expressed in U/L
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
GGT
Gamma glutamyl transferase levels expressed in U/L
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
ALP
Alkaline phosphatase levels expressed in U/L
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
ALT
Alanine aminotransferase levels expressed in U/L
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
AST
Aspartate aminotransferase levels expressed in IU/L
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
CRP
C-reactive protein levels expressed in mg/L
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
PLT
platelet count in microliter
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
LYM%
percent of lymphocytes
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
NEU%
percent of neutrophils
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
WBC
White blood cell count in microliter
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Hb
Hemoglobin values expressed as g/dL
Measured: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Jul 2021
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alirıza Erdoğan, Nigde Omer Halisdemir University
- Investigators
- Alirıza Erdoğan, MD, Principal investigator, Niğde Ömer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960189
- Sponsor's protocol ID
- 08.06.2021/32
- Status last verified
- Jan 2026
- First submitted
- 6 Jul 2021
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31768828Arer 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.
PubMed 28740954Zhou 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.
PubMed 26237977Yeo 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.
PubMed 25220656Na 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.
PubMed 19666085Andersson 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.
PubMed 8569551
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GB34 Acupuncture as Adjuvant in Early Phase of Medical Treatment of Mild Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT04960189
- Acronym / sponsor ID
- 08.06.2021/32
- Conditions
- Acute Cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureGB34 acupuncture will be applied every day. Patients will receive standard medical treatment |
| Controls | No intervention | –Patients will only receive standard medical treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed and hospitalised patients with mild acute cholecystitis
Key exclusion criteria (10 listed)
- Pregnant women
- Immunosuppressive patients
- Patients with intermediate and severe acute cholecystitis
- Patients with acalculous acute cholecystitis
- Patients with uncontrolled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture 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. | Procedure or surgery | Acupuncture |
Primary outcome
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.
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
17 secondary outcomes
Guarding
Time frame: 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.
Oral intake
Time frame: 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
Direct bilirubin
Time frame: 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
Amylase
Time frame: 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
ALP
Time frame: 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
AST
Time frame: 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
PLT
Time frame: 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
NEU%
Time frame: 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
Hb
Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 31768828Bouassida 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.
- Background: PubMed 28740954Arer 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.
- Background: PubMed 26237977Zhou 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.
- Background: PubMed 25220656Yeo 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.
- Background: PubMed 19666085Na 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.
- Background: PubMed 8569551Andersson 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.
- Individual participant dataSharing planned: No
Related trials for Acute Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
Cholecystitis, Acute, Biliary Diseases
Not yet recruiting
Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy
Cholecystitis, Acute, Cholecystectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alirıza Erdoğan, MD principal investigator
Niğde Ömer Halisdemir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Acute Cholecystitis, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04960189, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.