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A multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial for efficacy and safety of Simo Decoction in the treatment of functional constipation (qi stagnation)

A multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial for efficacy and safety of Simo Decoction in the treatment of functional constipation (qi stagnation)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2200005597
Enrollment
Unknown
Registered
2022-02-03
Start date
2022-01-31
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

Functional constipation (air stagnation)

Interventions

Control Group:Take Simo Decoction Placebo

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the western and Chinese diagnostic criteria for functional constipation (qi stagnation); (2) Those aged between 18 and 65 (both ends included); (3) Less than 3 times a week of fully spontaneous defecation; (4) Colonoscopy results were generally normal; (5) The subject is informed and voluntarily signs the informed consent; (6) Resident in local area, able to guarantee treatment follow-up, with certain reading ability.

Exclusion criteria

Exclusion criteria: (1) constipation caused by organic diseases (such as colon tumor, intestinal stenosis or obstruction, etc.); (2) endocrine and metabolic diseases such as diabetes and hypothyroidism; (3) drug-related constipation (such as opioids, etc.); (4) Patients with serious lesions of heart, liver and kidney, hematopoietic system diseases, nervous system diseases, muscle diseases and other system tumors; (5) have a history of mental illness (such as severe depression, severe anxiety); (6) Pregnant or lactating women who had a birth plan from enrollment to 1 month after the end of the study; (7) suspected or confirmed history of alcohol or drug abuse; (8) allergic to the test drug, emergency drug and its ingredients; (9) Patients who have participated in other clinical trials or are currently participating in other clinical trials within 1 month prior to inclusion; (10) the investigator considers it inappropriate to conduct clinical trials.

Design outcomes

Primary

MeasureTime frame
Emergency drug use;Symptoms associated with defecation;complete spontaneous bowel movement;TCM syndrome integral;Patient report clinical outcome evaluation Scale;

Countries

China

Contacts

Public ContactXudong Tang

Xiyuan Hospital, China Academy of Chinese Medical Sciences

txdly@sina.com.cn010-62835451

Outcome results

None listed

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