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

Not Applicable

Recruiting

Conditions: functional constipation with rectal hyposensitivity

Registration Number: ITMCTR2100005254

Lead Sponsor: onghua Hospital Shanghai University of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(1) Diagnostic with functional constipation by Rome ?;and Diagnostic with low rectal sensitivity:Rectal sensation measurement: the minimum sensation threshold is more than 20ml, the initial defecation threshold is more than 60ml or the maximum tolerance threshold is more than 250ml, which meet one or more requirements.
(2) syndrome with Qi and yin deficiency in traditional Chinese medicine;
(3) Unlimited course of disease;
(4) Patients aged from 18 to 80 (regardless of gender);
(5) Patients who have signed informed consent.

Exclusion Criteria

(1) Excluding those who do not meet the diagnostic criteria and inclusion criteria.
(2) There are malignant intestinal lesions, or perianal acute infection and bleeding diseases.
(3) There are serious diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, and psychiatric patients.
(4) diabetic patients with impaired glucose control (fasting blood glucose > 7.8mmol/L).
(5) Patients with severe infection and critical condition.
(6) Pregnant or lactating women, allergic constitution or abnormal liver function.
(7) According to the judgment of the researcher, other medical histories that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment, are easy to cause loss of follow-up.
(8) Subjects participating in clinical studies of other drugs.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cleveland clinic score, CCS;

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal electromyography;Patient assessment of constipation symptom, PAC-SYM;Rectal sensation;Anorectal manometry;Patient assessment of constipation quality of life;