Clinical Study of Acupoint Application on Relieving qi De... | NCT07276932

Status Module

Oversight Module

Description Module

Brief Summary

4.1 Research Content

Clarifying the acupoint application scheme for deficiency and constipation in CRC patients undergoing chemotherapy: the preliminary acupoint application scheme for deficiency and constipation in CRC patients was formulated according to the systematic literature search, analysis of acupoint and traditional Chinese medicine prescription, analysis of meridian tropism of acupoints, Chinese herbal medicine taste and meridian tropism, etc., and multidisciplinary expert consultation. Through two rounds of Delphi expert letter consultation, the acupoint application scheme for deficiency and secret of CRC patients undergoing chemotherapy was determined.
Randomized controlled trials were conducted to compare the effect of acupoint application scheme and conventional treatment in improving constipation symptoms, total clinical efficacy, and improving patient comfort rate in CRC patients undergoing chemotherapy.

4.2 Key problems to be solved Based on the theory of "state-target dialectics", the analysis of acupoints and traditional Chinese medicine prescriptions, the analysis of meridian tropism of acupoints, the flavor and meridian tropism of Chinese herbs are used to select Chinese herbs that moisten the intestine and relieve defecation, strengthen the central and qi, and explore the acupoint application to provide a basis for more effective application of acupoint application in the treatment of qi deficiency and constipation in patients with CRC chemotherapy, form a generalized integrated Chinese and western medicine diagnosis and treatment plan, and promote the development of integrated Chinese and western medicine.

4.3 Expected Goals

Clarify the diagnosis and treatment plan of acupoint application in the treatment of qi deficiency and constipation in patients with colorectal cancer.
The flexible application of classic formula and scientific acupoint selection and sticking can effectively relieve qi deficiency and constipation in CRC patients undergoing chemotherapy, improve the total clinical efficacy and comfort of patients. It has been used in clinical practice and promoted to other medical institutions.

Design Module

Interventional Study Design

Biospecimen

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Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acupoint application + conventional treatment and nursing program	Experimental		Drug: Acupoint application Behavioral: Routine treatment and nursing of constipation
Routine treatment and nursing of constipation	Active Comparator		Behavioral: Routine treatment and nursing of constipation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupoint application	Drug	The traditional Chinese medicine patch was prepared according to the ratio of astragalus: tangerine peel: sesame seed seed: white mustard seed = 6:6:2:1, and an appropriate amount of honey was used to make the shape. Timing of application: finger time (6:30 am). Acupoint prescription: Zusanli (bilateral), Zhongwan (CV 12), Qihai (CV 6) and Guanyuan (CV 4). Location of acupoint: the patient went to the supine position or sitting position with knee flexion. Zusanli (Zusanli) is three cun below the outer knee of both lower limbs; Zhongwan (CV 12) is located from xiphoid process to navel midpoint. Qihai acupoint is located on the median line of the human abdomen, three transverse fingers down from the umbilicus. Location of Guanyuan point: 3 cun (four fingers) below the belly button. Treatment time and frequency: once a day, 2 hour

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Nimodipine method was used to calculate the total symptom score of patients	Efficacy index =[(pre-treatment score - post-treatment score)/pre-treatment score]× 100%, which was divided into 4 grades: clinical cure, marked effect, effective and ineffective. Clinical recovery: the main symptoms and signs disappeared or basically disappeared, and the efficacy index was ≥ 95%. Marked efficacy: the main symptoms and signs were significantly improved, 70% ≤ efficacy index < 95%; Effective: the main symptoms and signs were significantly improved, 30% ≤ efficacy index < 70%; Ineffective: the main symptoms and signs were not significantly improved, or even aggravated, and the efficacy index was less than 30%.	Five days after the intervention
Constipation symptom assessment form	It was formulated by the Anorectal Surgery Group of Chinese Society of Surgery of Chinese Medical Association, and included six dimensions: defecation frequency, defecation time, defecation difficulty, stool character, abdominal distension, falling, incomplete and fullness. A 4-point scale was used to evaluate the severity of symptoms.The higher the score, the more severe the constipation symptoms.The minimum score was 0 and the maximum score was 18.	Before and after 5 days of intervention

Secondary Outcomes

Measure	Description	Time Frame
Chinese version of Symptom Checklist for Constipation (PAC-SYM)	Developed by MaPi Research Trust in France, it has good reliability and validity and has been widely used in clinical practice. The questionnaire included 3 dimensions and 12 items, including stool shape, rectal and abdominal symptoms, etc. The severity of symptoms was evaluated using a 5-point scale. The higher the score, the more severe the patient's constipation symptoms. The lowest score was 0 and the highest score was 48.

Eligibility Module