Study on the Immediate Analgesic Effect of Yanglingquan Acupoint Treatment for Biliary Colic

NCT07194655 | Not Yet Recruiting

• 1 other identifier: NKYY_YX_IRB_SOP_016(F）_002_04
• Study Type: interventional
• Target: 248
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Biliary Colic

Keywords

Biliary colic

Outcome Measures

Primary Outcomes (4)

• Simplified McGill Pain Questionnaire (SF-MPQ) Score：Visual Analogue Scale (VAS)

  This is a simple, single-dimensional method for measuring pain intensity, which consists of a 10-centimeter horizontal line. The left end is marked with "No pain", and the right end is marked with "most severe pain". The patient marks a point on the line representing the current intensity of their pain.The higher the score, the worse the result.

  One week from enrollment to the end of treatment

• Simplified McGill Pain Questionnaire (SF-MPQ) Score：Pain Index (PRI)

  It contains 15 pain description words, which are divided into two categories: sensory items (11 words) : throbbing pain, shooting pain, stabbing pain, sharp pain, spastic pain, biting pain, heat-burning pain, aching pain, heavy pain, touch pain, tearing pain. Emotional items (4 words) : Tiredness - feeling exhausted, nauseating, fear, punishment - feeling tormented. PRI scoring criteria: 0 = None; 1= mild; 2= moderate; 3= Severe. Calculate the total score. The higher the score, the worse the result.

  One week from enrollment to the end of treatment

• Simplified McGill Pain Questionnaire (SF-MPQ) Score-Current Pain Intensity (PPI)

  This is a single overall score for the current intensity of pain. It adopts a 5-point scoring method: 0= painless; 1= Mild pain; 2= uncomfortable pain; 3= Distress pain; 4= Terrifying pain; 5= Extreme pain. The higher the score, the worse the result.

  One week from enrollment to the end of treatment

• Gallstones Traditional Chinese Medicine Syndrome Scoring

  Referring to the relevant content of the "Clinical Guidelines for New Traditional Chinese Medicine Drugs (Trial)" 2002 edition "Gallstones" chapter, a quantitative scoring table for TCM syndromes was formulated. This study scored three symptoms: right upper abdominal pain, tenderness in the gallbladder area, and nausea and vomiting. The main symptoms (pain type) were scored as 0 points, 3 points, 6 points, and 9 points respectively for asymptomatic, mild symptoms, moderate symptoms, and severe symptoms. For secondary symptoms (nausea and vomiting), scores of 0, 1, 2, and 3 are given based on the above conditions. The minimum value is 0 points and the maximum value is 12 points.The scoring time is before treatment and 12 hours after treatment.The higher the score, the worse the result.

  One week from enrollment to the end of treatment

Secondary Outcomes (4)

• Biliary tract ultrasound

  One week from enrollment to the end of treatment

• The levels of plasma C-reactive protein (CRP)

  One week from enrollment to the end of treatment

• The levels of plasma cholecystokinin (CCK)

  One week from enrollment to the end of treatment

• The levels of plasma β -endorphin (β-EP)

  One week from enrollment to the end of treatment

Study Arms (4)

Control group

NO INTERVENTION

Drug therapy only

Acupuncture group A

EXPERIMENTAL

Acupuncture at the Yanglingquan point

Other: Acupuncture at the Yanglingquan point

Acupuncture group B

EXPERIMENTAL

Acupuncture at the Xiabai Point

Other: Acupuncture at the Xiabai Point

Acupuncture group C

SHAM COMPARATOR

Acupuncture at non-meridian points

Other: Acupuncture at non-meridian points

Interventions

Acupuncture at the Yanglingquan point OTHER

Acupuncture at the Yanglingquan point

Acupuncture group A

Acupuncture at the Xiabai Point OTHER

Acupuncture at the Xiabai Point

Acupuncture group B

Acupuncture at non-meridian points OTHER

Acupuncture at non-meridian points

Acupuncture group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: the study is limited to specific, self-identified genders
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: lead
• Tianjin Medical University General Hospital: collaborator
• Tianjin Hospital of Integrated Traditional Chinese and Western Medicine: collaborator

Related Publications (2)

• Begona Barroso M, de Jong AP. A new design for large, dilute sample loading in capillary electrophoresis. J Capillary Electrophor. 1998 Jan-Apr;5(1-2):1-7.

  PMID: 10327363 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

JING Li

CONTACT

86-022-18920351627; 1725155193@qq.com

Jiawen Dong

CONTACT

dongjiawen0511@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiciancertified doctor

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share