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Clinical Study on Yiqi Kaimi Recipe Combined with Biofeedback in the Treatment of Functional Constipation with Rectal Hyposensitivity

Clinical Study on Yiqi Kaimi Recipe Combined with Biofeedback in the Treatment of Functional Constipation with Rectal Hyposensitivity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050596
Enrollment
Unknown
Registered
2021-09-01
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

functional constipation with rectal hyposensitivity

Interventions

Control group1:Conventional drug therapy (polyethylene glycol or lactulose)
Control group2:Yiqi Kaimi Recipe
Experimental group:Yiqi Kaimi Recipe + biofeedback

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of western medicine for functional constipation; 2. In line with the standard of TCM syndrome differentiation of Qi and Yin deficiency; 3. The course of the disease is not limited; 4. Patients aged 18 to 80 years old (gender is not limited); 5. Patients who have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. There are malignant intestinal lesions, or acute perianal infection and bleeding diseases; 2. Combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, mental patients; 3. Diabetic patients with unsatisfactory blood sugar control (fasting blood sugar>7.8mmol/L); 4. Patients with severe infection and critical illness; 5. Pregnant or lactating women, allergic constitution or abnormal liver function; 6. According to the judgment of the investigator, other medical histories that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment, are likely to cause loss to follow-up; 7. Subjects who are participating in clinical studies of other drugs.

Design outcomes

Primary

MeasureTime frame
Cleveland clinic score;

Secondary

MeasureTime frame
Patient assessment of constipation symptom;Patient assessment of constipation quality of life;Anorectal manometry;Rectal sensation;Gastrointestinal electromyography;

Countries

China

Contacts

Public ContactWang Chen

Longhua Hospital Shanghai University of Traditional Chinese Medicine

wangchen_longhua@163.com+86 18917763340

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026