Constipation Clinical Trial
Official title:
Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
NCT number | NCT06156995 |
Other study ID # | GlWu |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2023 |
Est. completion date | December 31, 2023 |
Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Meets the diagnostic criteria for Slow transit constipation deficiency of both qi and yin; - Age 18-65 years old; - I have not been treated with intestinal motility drugs in the past month. - Those who have informed consent and voluntarily participate in signing an informed consent form, adhere to medical advice for treatment, and undergo regular follow-up visits. Exclusion Criteria: - Other Traditional Chinese Medicine Syndrome Differentiation Types of Constipation. - Concomitant severe heart, lung, and kidney diseases, neurological diseases, and metabolic diseases; - Discovering organic lesions such as colorectal cancer and colorectal hyperplasia through colonoscopy, abdominal pelvic CT, or barium enema; - Patients with severe mental illness or mental illness or cognitive impairment. - Children, pregnant women, lactating women, and pregnant women. - Those who stop taking medication at will or use other medications on their own during treatment, do not follow medical advice for treatment, or have incomplete information that affects the judgment of results, safety, and efficacy. - Have a history of abdominal surgery. - History of needle sickness. - People with a tendency to bleed. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Shandong First Medical University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Guoliang Wu | Qianfoshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Cleveland Constipation Score(CCS) | The Clinical Scoring Scale for Constipation Patients (CCS) is mainly a scoring standard for quantifying the severity of constipation. Its content mainly includes 8 items: frequency of defecation, difficulty in defecation, feeling of incomplete defecation, abdominal pain, defecation time, type of help needed, frequency of difficulty in resolving constipation every 24 hours, and duration of constipation. The score range is 0-30 points, and the higher the score, the more severe the constipation is. | Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment. | |
Primary | Changes in the score of Bristol fecal trait scale | Type 1 is a separated hard mass, type 2 is a clump shape, type 3 is a dry and cracked sausage shape, type 4 is a soft sausage shape, type 5 is a soft mass, type 6 is a mud shape, and type 7 is a watery stool. Each patient is assigned a score of 1-7. The patient confirms their stool classification based on the Bristol fecal trait scale and records it. | Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment. | |
Secondary | Changes in the frequency of complete spontaneous bowel movements (CSBM) | Complete spontaneous bowel movement (CSBM) refers to the number of times a patient can spontaneously defecate and feel completely discharged every week without taking remedial laxatives or manual assistance;Observation indicators are mainly based on the defecation record card provided by the patient. | Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment. | |
Secondary | Changes in the frequency of spontaneous bowel movements (SBM) | Spontaneous bowel movement (SBM) refers to the number of times a patient spontaneously defecates per week, including feeling exhausted and feeling unable to defecate. Observation indicators are mainly based on the defecation record card provided by the patient. | Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment. | |
Secondary | Changes in the Quality of Life Scale (PAC-QOL) scores of patients with constipation | The international constipation patient quality of life rating scale designed based on PROs is mainly a survey questionnaire for the quality of life of constipation patients. Patients are scored before and after treatment, and physicians collect and record their individual and total scores for physical discomfort, psychological discomfort, constipation related anxiety, and satisfaction with treatment. The score is 0-112 points, and the higher the score, the worse the quality of life. | Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment. | |
Secondary | Incidence of the adverse reactions | The acupuncture operator records the adverse reactions of the patient after the acupuncture operation (such as dizziness, infection, pelvic organ and nerve damage, etc.). | Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment. |
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