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A prospective case series study of Liqirunchang granule in the treatment of chronic functional constipation

A prospective case series study of Liqirunchang granule in the treatment of chronic functional constipation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2023000055
Enrollment
Unknown
Registered
2023-10-23
Start date
2023-10-30
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Chronic functional constipation

Interventions

Liqi Runchang granule group:Li Qi Runchang granule

Sponsors

Guangdong Pharmaceutical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ?In accordance with the Rome IV functional constipation diagnostic criteria: 1) The symptoms of constipation have persisted for at least six months, with occurrences in the last three months, including two or more of the following: a. Experiencing difficulty in bowel movements at least four times, with at least one instance being strenuous. b. Having hard or lumpy stool at least four times, with at least one instance being hard. c. Feeling of incomplete evacuation during bowel movements at least four times. d. Sensation of anal blockage during bowel movements at least four times. e. Requiring manual assistance for bowel movements at least four times. f. Spontaneous bowel movements occurring less than three times per week. 2) Loose stools are infrequent when laxatives are not used. 3) Exclusion of constipation-predominant irritable bowel syndrome. 4) Exclusion of organic or systemic diseases affecting the gastrointestinal tract. 5) Exclusion of constipation caused by opioids. ?. In accordance with the traditional Chinese medicine diagnosis for this study: According to the 2017 Consensus Opinion of the Gastrointestinal Disease Branch of the Chinese Association of Chinese Medicine, the proposed symptoms are as follows: Main Symptoms: difficulty in bowel movements, dry and hard stool, straining with perspiration. Secondary Symptoms: abdominal distention, abdominal pain, dry mouth with desire to drink, fatigue. Diagnosis can be made if one main symptom and one secondary symptom are present. ?. The age range is between 18 and 80 years, regardless of gender. ?. Willingness to sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for clinical observation are as follows: 1. Individuals with a history of gastrointestinal surgery or significant surgical indications in the three months prior to screening. 2. Patients with organic colonic lesions such as tumors, polyps, or colonic tuberculosis causing intestinal obstruction and constipation. 3. Patients diagnosed with active diverticulosis, severe hemorrhoids, anal fissures, or those with artificial rectum or anus. 4. Women who are pregnant or planning to become pregnant, as well as lactating women. 5. Diagnosis of pelvic diseases believed to have a significant impact on fecal colonic transit (e.g., uterine prolapse = grade 2, uterine fibroids [located in the posterior uterus, diameter = 5 cm] affecting defecation). 6. Individuals with a predisposition to Chinese medicine allergies, severe cognitive impairments, or psychiatric abnormalities. 7. Patients with hyperthyroidism, severe hypertension, heart disease, systemic infections, or coagulation disorders (hypercoagulable state or bleeding tendency), or those with other severe conditions affecting the heart, brain, liver, kidneys, or hematological system. 8. Poor compliance, patients involved in other research projects in the past month. 9. Patients currently undergoing treatment for constipation or those who have taken similar medications with effects that may impact the evaluation of this study's efficacy within the past week. 10. Patients deemed ineligible for the study based on other relevant treatments and medical findings by the researchers.

Design outcomes

Primary

MeasureTime frame
Proportion of total treatment effectiveness;

Secondary

MeasureTime frame
TCM Syndrome Scale of Glycolipid Metabolism;Average score of Constipation Severity Scale;rescue drug;Hamilton Anxiety Scale;intestinal bacteria;Average value of SBMs and CSBM per week;The average value of anal rectal pressure measurement;Average score of Constipation Assessment Scale;Hamilton Depression Scale;Average score of Patient Assessment of Constipation Quality Of Life;Mean score on the Bristol faecal scale for faecal consistency;

Countries

China

Contacts

Public ContactGuo Jiao; Jin Yinghua

The First Affiliated Hospital of Guangdong Pharmaceutical University

gyguoyz@163.c+86 20 3935 2609

Outcome results

None listed

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