Study on the Immediate Analgesic Effect of Yanglingquan Acupoint Treatment for Biliary Colic
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture at the Yanglingquan point, Acupuncture at the Xiabai Point, Acupuncture at non-meridian points.
- Who it may be relevant to
- Registry conditions: Biliary Colic. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Guided by traditional meridian and acupoint theory, conducting standardized, large-sample, multicenter randomized controlled trials (RCTs) to evaluate the clinical efficacy of pattern differentiation and meridian-based acupoint selection for biliary colic across multiple levels can provide high-quality research evidence for developing evidence-based guidelines or optimal treatment protocols. This holds significant importance for enhancing the clinical efficacy of acupuncture in treating biliary colic and promoting its widespread clinical application. Therefore, this study will conduct a multicenter, large-sample randomized controlled trial comparing the clinical effects of acupuncture at Yanglingquan (GB34) versus drug therapy for acute cholecystitis biliary colic. It aims to investigate the clinical efficacy and safety of acupuncture treatment for acute cholecystitis biliary colic.
Interventions
- Other Acupuncture at the Yanglingquan point
Acupuncture at the Yanglingquan point - Other Acupuncture at the Xiabai Point
Acupuncture at the Xiabai Point - Other Acupuncture at non-meridian points
Acupuncture at non-meridian points
Primary outcome measures
- Simplified McGill Pain Questionnaire (SF-MPQ) Score：Visual Analogue Scale (VAS) [Time frame: One week from enrollment to the end of treatment]
- Simplified McGill Pain Questionnaire (SF-MPQ) Score：Pain Index (PRI) [Time frame: One week from enrollment to the end of treatment]
- Simplified McGill Pain Questionnaire (SF-MPQ) Score-Current Pain Intensity (PPI) [Time frame: One week from enrollment to the end of treatment]
- Gallstones Traditional Chinese Medicine Syndrome Scoring [Time frame: One week from enrollment to the end of treatment]
Secondary outcome measures (4)
- Biliary tract ultrasound [Time frame: One week from enrollment to the end of treatment]
- The levels of plasma C-reactive protein (CRP) [Time frame: One week from enrollment to the end of treatment]
- The levels of plasma cholecystokinin (CCK) [Time frame: One week from enrollment to the end of treatment]
- The levels of plasma β -endorphin (β-EP) [Time frame: One week from enrollment to the end of treatment]
Eligibility criteria
Inclusion criteria
- Meets diagnostic criteria for cholecystitis according to both Chinese and Western medicine;
- Patients exhibiting clinical manifestations of biliary colic with a Visual Analogue Scale (VAS) score >4;
- Aged 18 to 65 years;
- Patients provide informed consent and voluntarily participate in this study.
Exclusion criteria
- Patients meeting criteria for emergency surgery;
- Patients with psychiatric issues unable to cooperate with treatment;
- Patients with severe complications such as suppurative cholecystitis, suppurative cholangitis, acute pancreatitis, gallbladder perforation, tumors, or severe infections;
- Patients with other serious comorbidities including liver, brain, kidney, or cardiovascular diseases;
- Patients with severe local lesions (e.g., infections, burns, scalds) where acupuncture is contraindicated;
- Pregnant women and lactating women;
- Patients who have already undergone other treatment modalities.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Zhou Y, Shen Y, Ye X, He D, Sun N, Zhang Y, Zhang Y, Long C, Ding S, Deng L, Deng Y, Liang F, Gong X, Sun R. Acupuncture on GB34 for immediate analgesia and regulating pain-related anxiety for patients with biliary colic: a protocol of randomized controlled trial. BMC Complement Med Ther. 2023 Jul 7;23(1):224. doi: 10.1186/s12906-023-04030-8. PMID 37420212
- Patel R, Tse JR, Shen L, Bingham DB, Kamaya A. Improving Diagnosis of Acute Cholecystitis with US: New Paradigms. Radiographics. 2024 Dec;44(12):e240032. doi: 10.1148/rg.240032. PMID 39541246
Identifiers
NCT: NCT07194655 · NKYY_YX_IRB_SOP_016(F）_002_04