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NCT Number: NCT07194655

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

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.

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Key information

Conditions

Biliary Colic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture at the Yanglingquan point

Other

Acupuncture at the Yanglingquan point

Acupuncture at the Xiabai Point

Other

Acupuncture at the Xiabai Point

Acupuncture at non-meridian points

Other

Acupuncture at non-meridian points

Primary outcomes

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

    Time frame: One week from enrollment to the end of treatment

    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.

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

    Time frame: One week from enrollment to the end of treatment

    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.

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

    Time frame: One week from enrollment to the end of treatment

    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.

  4. Gallstones Traditional Chinese Medicine Syndrome Scoring

    Time frame: One week from enrollment to the end of treatment

    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.

Secondary outcomes

  1. Biliary tract ultrasound

    Time frame: One week from enrollment to the end of treatment

    Maximum longitudinal diameter (L) and anterior-posterior diameter (W) of the gallbladder

  2. The levels of plasma C-reactive protein (CRP)

    Time frame: One week from enrollment to the end of treatment

    The levels of plasma C-reactive protein (CRP)were detected before the start of treatment and 30 minutes after treatment.The measurement unit is mg/L.

  3. The levels of plasma cholecystokinin (CCK)

    Time frame: One week from enrollment to the end of treatment

    The levels of plasma cholecystokinin (CCK) were detected before the start of treatment and 30 minutes after treatment.The measurement unit is pmol/L.

  4. The levels of plasma β -endorphin (β-EP)

    Time frame: One week from enrollment to the end of treatment

    The levels of plasma β -endorphin (β-EP) were detected before the start of treatment and 30 minutes after treatment.The measurement unit is pg/mL.

Study contacts

Contact information is provided by the study sponsor or research team.

JING Li

CONTACT

[email protected]

86-022-18920351627

Jiawen Dong

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Other

Collaborators

  • Tianjin Hospital of Integrated Traditional Chinese and Western Medicine
  • Tianjin Medical University General Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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