ConstipationNCT06156995
Deep Needling at Zhongliao Point to Stimulate the Sacral Nerve for the Treatment of Slow Transit Constipation
A study testing Deep Acupuncture at Zhongliao Point to Stimulate Sacral Nerve and Oral Mosapride Tablets in people with Constipation, run by Guoliang Wu at 1 site in China.
Trial summary
Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Constipation
- What is being tested?
- Deep Acupuncture at Zhongliao Point to Stimulate Sacral Nerve and Oral Mosapride Tablets
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Have a history of abdominal surgery.
- History of needle sickness.
- People with a tendency to bleed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
Wu Guoliang, M.D., +8618264136209
About this study
Official title: Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
Read the detailed description
- Observing the clinical efficacy of deep acupuncture at Zhongliao point to stimulate the sacral nerve in the treatment of slow transit constipation of the colon through changes in main research indicators such as defecation frequency, stool shape, and fecal weakness.
- Clarify the technical focus and difficulties of deep needling at Zhongliao point to stimulate the sacral nerve in the treatment of colonic slow transit constipation, providing a basis for guiding clinical promotion and treatment.
- Conditions
- Constipation
- Being tested
- Deep Acupuncture at Zhongliao Point to Stimulate Sacral Nerve, Oral Mosapride Tablets
- Keywords
- Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Acupuncture at Zhongliao Point to Stimulate Sacral NerveDevice
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.
Oral Mosapride TabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 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. Receives: Device: Deep Acupuncture at Zhongliao Point to Stimulate Sacral Nerve |
| control group | Active comparator | 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. Receives: Drug: Oral Mosapride Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
Secondary outcomes (4)
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.
Measured: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
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.
Measured: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
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.
Measured: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
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.).
Measured: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guoliang Wu
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital
- Responsible party
- Sponsor-investigator, Guoliang Wu, Qianfoshan Hospital
- Investigators
- Pang jing, M.D., Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156995
- Sponsor's protocol ID
- GlWu
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
- ClinicalTrials.gov ID
- NCT06156995
- Acronym / sponsor ID
- GlWu
- Conditions
- Constipation
- Keywords
- Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Guoliang WuUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve
Detailed description
- Observing the clinical efficacy of deep acupuncture at Zhongliao point to stimulate the sacral nerve in the treatment of slow transit constipation of the colon through changes in main research indicators such as defecation frequency, stool shape, and fecal weakness.
- Clarify the technical focus and difficulties of deep needling at Zhongliao point to stimulate the sacral nerve in the treatment of colonic slow transit constipation, providing a basis for guiding clinical promotion and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Deep Acupuncture at Zhongliao Point to Stimulate Sacral NerveUsing 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. |
| control group | Active comparator | Drug: Oral Mosapride TabletsMosapride 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Acupuncture at Zhongliao Point to Stimulate Sacral NerveUsing 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. | Device | Treatment group |
| Oral Mosapride TabletsMosapride 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. | Drug | control group |
Primary outcome
Changes in Cleveland Constipation Score（CCS）
Time frame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
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.
Changes in the score of Bristol fecal trait scale
Time frame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
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.
4 secondary outcomes
Changes in the frequency of complete spontaneous bowel movements (CSBM)
Time frame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
Changes in the frequency of spontaneous bowel movements (SBM)
Time frame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
Changes in the Quality of Life Scale (PAC-QOL) scores of patients with constipation
Time frame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
Incidence of the adverse reactions
Time frame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pang jing, M.D. principal investigator
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Acupuncture at Zhongliao Point to Stimulate Sacral Nerve and Oral Mosapride Tablets in people with Constipation, run by Guoliang Wu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wu Guoliang, M.D. (8618264136209, wuguoliang@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cleveland Constipation Score（CCS） (time frame: Each group of patients was evaluated for indicators 1 week before treatment, 4 weeks after treatment, and 8 weeks after treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.