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A randomized controlled study on the combination of acupuncture and medication in the treatment of Qi deficiency constipation during the recovery period of stroke from the perspective of spleen and a preliminary exploration of its impact on Gut microbiota metabolites (TMAO)

A randomized controlled study on the combination of acupuncture and medication in the treatment of Qi deficiency constipation during the recovery period of stroke from the perspective of spleen and a preliminary exploration of its impact on Gut microbiota metabolites (TMAO)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001518
Enrollment
Unknown
Registered
2026-06-20
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-stroke constipation

Interventions

Experimental group(Acupuncture-medicine combination treatment group):The modified Jiawei Baizhu decoction and the acupuncture formula of the modified Buzhong Yiqi
Control Group (Western Medicine Group):Lactulose Oral Solution

Sponsors

Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1)It simultaneously meets the diagnostic criteria of both traditional Chinese and Western medicine for stroke and constipation (2) It meets the diagnostic criteria for constipation caused by qi deficiency (3) Constipation or aggravation occurs after a stroke, and the course of the stroke is =15 days but less than 180 days (4) The patient's age is within the range of 40 to 75 years old (including both 40 and 75 years old), regardless of gender (5)With the informed consent of the patient and their family, and the patient voluntarily participating in and cooperating with the treatment plan stipulated in this study

Exclusion criteria

Exclusion criteria: (1)Patients with organic lesions in the intestines, such as colonic polyps, intestinal tuberculosis, intestinal tumors and other lesions (2) Long-term use of drugs with constipation side effects, such as anticholinergic drugs and antidepressants, etc (3)Constipation in patients caused by intestinal obstruction due to hemorrhoids or inflammatory reactive colitis (4)Pregnant or lactating women, or those with combined coagulation disorders, hepatosplenomegaly, liver and kidney failure, and severe heart diseases, etc (5)Patients with consciousness or mental abnormalities who are unable to cooperate normally with the implementation of the research protocol (6)Patients who are participating in clinical trials of other drugs

Design outcomes

Primary

MeasureTime frame
the number of complete spontaneous bowel movements per week;

Secondary

MeasureTime frame
the number of spontaneous bowel movements per week;Constipation symptom score;Patient Assessment of Constipation Symptoms;Bristol Fecal Properties Assessment Form;Quality of life score of patients with constipation;National Institutes of Health Stroke Scale;TCM syndrome scoring for constipation due to qi deficiency;Serum trimethylamine oxide concentration;

Countries

China

Contacts

Public ContactFu Caihong

Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital

caihong-fu@163.com15201218434

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026