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 )

Phase 1

• Conditions: Healthy people

• Registration Number: ITMCTR2200006140
• Lead Sponsor: Dongzhimen Hospital, Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;