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A randomized cross-over controlled trial study on the regulation of gut microbiota by traditional Chinese medicine of the four properties(cold, hot, warm and cool )

A randomized cross-over controlled trial study on the regulation of gut microbiota by traditional Chinese medicine of the four properties(cold, hot, warm and cool )

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006140
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
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

Healthy people

Interventions

Group 4:Astragalus recipe granules
Group 2: Cinnamon recipe granules
Group 1:Coptis recipe granules
Group 3:Anemarrhenae recipe granules

Sponsors

Dongzhimen Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. The age is between 18-35 years old, and the gender is not limited; 2. Body mass index between 18.5-23.9kg/m2; 3. Those whose constitution is peaceful; 4. Have not taken any medicines in the past 4 weeks; 5. No previous major diseases; 6. Those who can insist on taking the medicine; 7. The patient gave informed consent and signed the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with severe arrhythmia, atrial fibrillation, and heart failure; those with severe primary diseases of the heart, liver, kidney, hematopoietic system, endocrine system, and respiratory system, and whose liver function is more than 1.5 times the upper limit of normal; 2. Pregnant or lactating women; 3. People with allergies; 4. Other diseases or mental illnesses that the investigator believes may limit the evaluation of efficacy or patient follow-up; 5. Patients who have participated in clinical trials of other drugs within the past 4 weeks.

Design outcomes

Primary

MeasureTime frame
Intestinal flora: Stool samples were collected at the time points specified in the plan;TCM constitution score;Blood proteomics: Blood samples are collected at the specified time points in the protocol;Sleep status (sleep duration at night, number of night rise);Daily number of defecation, time of defecation, stool characteristics;

Countries

China

Contacts

Public ContactWu Shengxian

Dongzhimen Hospital, Beijing University of Chinese Medicine

wushx@sina.com13501382919

Outcome results

None listed

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