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Based on the effect of intestinal microecology on mitochondrial energy supply, this study explored the efficacy of Jiawei Qilang prescription in the treatment of drug-dependent constipation

Clinical evaluation of modified Qilang prescription in the treatment of drug-dependent constipation by improving intestinal microecology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005525
Enrollment
Unknown
Registered
2022-01-11
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Constipation

Interventions

treatment group:jiawei qilang power+Duphalacsimulation agent treatment
control group:jiawei qilang simulation power+Duphalac

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The TCM diagnostic criteria of Qi-Yin deficiency syndrome (refer to the consensus of TCM experts in diagnosis and treatment of constipation of spleen and stomach Disease Branch of Chinese Society of traditional Chinese Medicine (2017)) the main symptoms are as follows: reduced defecation frequency, prolonged defecation cycle, or difficult fecal quality, difficulty in defecation, or weakness in defecation. Secondary symptoms: Qi deficiency: 1) fatigue and lazy speech; 2) stupefaction; 3) abdominal distension and yin deficiency: 1) hand and foot heart heat; 2) body weight loss; 3) worry and lack of sleep. In line with at least 2 main symptoms, 2 secondary syndromes, qi deficiency and yin deficiency, each disease symptom grading and quantification combined with the guiding principles and related principles of clinical research of new drugs of traditional Chinese medicine. 2.2 Western diagnostic criteria: (1) constipation: the diagnostic criteria are established with reference to the Rome IV diagnostic criteria, as follows: at least 12 weeks in the past 6 months (not necessarily continuous) the following two or more things have occurred: strenuous defecation of more than 11pm; dry knot or hardness of defecation above 21mm4 (refer to Bristol stool trait 1 or 2); and incomplete defecation in defecation of more than 31mm4. 3There is a sense of anorectal obstruction or obstruction when defecation above 41p4, extra help (finger picking, pelvic floor massage) is needed when defecation is above 41x4, spontaneous defecation is less than 3 times a week, and there is no loose defecation, and it is not enough to diagnose irritable bowel syndrome. (2) the history of discontinuation or continuous use of laxatives containing anthraquinones in one year was more than 6 months, and the course of disease was more than 1 year. (3) others: organic diseases were excluded by relevant examination. 2.3 the inclusion criteria meet the diagnostic criteria of western medicine for drug-dependent constipation; the syndrome differentiation of traditional Chinese medicine is deficiency of both qi and yin; the age is from 18 to 70 years old (including 18 and 70 years old); voluntarily participate in this experiment and agree to sign informed consent.

Exclusion criteria

Exclusion criteria: Complicated with organic diseases such as digestive tract, cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and other serious primary diseases; patients with a history of mental illness or mental illness; patients less than 18 years old or more than 70 years old; patients who could not tolerate drug treatment in this study; pregnant and lactating women; any situation considered unsuitable for selection in the study

Design outcomes

Primary

MeasureTime frame
High-throughput 16SrDNA sequencing and analysis of feces;5-hydroxytryptamine;

Contacts

Public ContactLi Yong
liyong_SCI@126.com021-56639828

Outcome results

None listed

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