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

Tianjin University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Biliary Colic

Treatments: Other: Acupuncture at non-meridian points; Other: Acupuncture at the Xiabai Point; Other: Acupuncture at the Yanglingquan point

Study type: Interventional

Funder types: Other

Identifiers

NCT07194655

NKYY_YX_IRB_SOP_016(F）_002_04

Details and patient eligibility

About

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.

Enrollment: 248 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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248 participants in 4 patient groups

Control group

No Intervention group

Description:

Drug therapy only

Acupuncture group A

Experimental group

Description:

Acupuncture at the Yanglingquan point

Treatment:

Other: Acupuncture at the Yanglingquan point

Acupuncture group B

Experimental group

Description:

Acupuncture at the Xiabai Point

Treatment:

Other: Acupuncture at the Xiabai Point

Acupuncture group C

Sham Comparator group

Description:

Acupuncture at non-meridian points

Treatment:

Other: Acupuncture at non-meridian points