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A single-arm single-center exploratory clinical trial of tonic lifting granules for the treatment of low anterior resection syndrome (spleen deficiency and sag type)

A single-arm single-center exploratory clinical trial of tonic lifting granules for the treatment of low anterior resection syndrome (spleen deficiency and sag type)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000729
Enrollment
Unknown
Registered
2025-04-13
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Low anterior resection syndrome (spleen deficiency and sunken type)

Interventions

Experimental group:On the basis of conventional treatment patients are given oral tonic lifting granules

Sponsors

Shanxi Provincial Institute of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. year after the anterior resection of rectal cancer if there is a stoma more than 6 months after the closure of the ostomy resection; 2.Meet the diagnostic criteria for LARS and have a LARS score of > 20; 3.TCM syndrome differentiation is spleen deficiency and depression type; 4.Age= 18 years old gender is not limited;5. Basic communication skills and comprehension skills able to cooperate with examinations treatment and follow-up;6. Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with local or distant metastases of tumors who are undergoing surgery chemoradiotherapy immunotherapy and targeted therapy; 2.Presence of anal sphincter injury anal deformity inflammatory bowel disease or other diseases that cause anorectal dysfunction before surgery; 3.Patients with a history of anorectal surgery pregnancy active infection or inflammation active anal fissure; 4.Patients who have been taking drugs for a long time that may affect intestinal function and anal defecation function; 5.Patients with severe heart liver kidney and other systemic diseases cognitive impairment or mental diseases that cannot cooperate;6. Postoperative complications such as anastomotic leakage anastomotic bleeding stenosis intestinal perforation and intestinal obstruction;7. Patients with expected survival < 6 months; 8.Refusal to continue to participate in the follow-up of this study;9. Receipt of other LARS-related treatments within one month prior to enrollment;10. Patients participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
4-week LARS score;

Secondary

MeasureTime frame
Xu Zhongfa's "5-item 10-point system" rectal function score;The IBS-QoL questionnaire assesses quality of life;2-week LARS score;The efficacy of traditional Chinese medicine on syndromes and the efficacy of traditional Chinese medicine on individual symptoms;

Countries

China

Contacts

Public ContactHao Shulan

Shanxi Provincial Institute of Traditional Chinese Medicine

dxl328321@163.com+86 138 3415 6416

Outcome results

None listed

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