Clinical trial
Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
Name
GlWu
Description
Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
Trial arms
Trial start
2023-01-01
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Recruiting
Treatment
Deep Acupuncture at Zhongliao Point to Stimulate Sacral Nerve
Using 0.30mm × 75mm millineedle (produced by Suzhou Medical Equipment Factory, Huatuo brand) deeply punctures the Zhongliao acupoint to reach the sacral nerve. The acupuncture needle is connected using the MuhiStim Sensor nerve stimulator produced by Pajunk in Germany. Connect the positive pole to the left Zhongliao hole and the negative pole to the right Zhongliao hole. The frequency, current, and pulse width of sacral nerve electrical stimulation are 2 Hz, 5mA, and 0.1 ms, respectively.Electroacupuncture stimulates the sacral nerve for 30 minutes, once a day, five times a week. After the treatment, rest for two days before starting the next treatment. Five sessions are considered as one course of treatment, with a total of four courses for four consecutive weeks.
Arms:
Treatment group
Oral Mosapride Tablets
Mosapride citrate tablets (produced by Lunan Beite Pharmaceutical Co., Ltd., with the national drug approval number H19990317), oral administration, 5mg once, three times a day, taken before meals. 5 days is one course of treatment, with 2 days of rest during the treatment period. The total treatment period is 4 weeks, with a total of 4 courses.
Arms:
control group
Size
70
Primary endpoint
Changes in Cleveland Constipation Score（CCS）
Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
Changes in the score of Bristol fecal trait scale
Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}
Updated at
2023-12-05
1 organization
1 product
1 indication
Organization
Guoliang WuProduct
MosaprideIndication
Constipation