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The biological basis of damp-heat constitution susceptible to hyperuricemia based on microbial metabolism-epigenetic axis and the pharmacological mechanism of the formula with the same origin of medicine and food to regulate damp-heat constitution

Registration number：

ITMCTR2024000751

Date of Last Refreshed on：

2024-11-27

Date of Registration：

2024-11-27

Registration Status：

Retrospective registration

Public title：

The biological basis of damp-heat constitution susceptible to hyperuricemia based on microbial metabolism-epigenetic axis and the pharmacological mechanism of the formula with the same origin of medicine and food to regulate damp-heat constitution

English Acronym：

Scientific title：

The biological basis of damp-heat constitution susceptible to hyperuricemia based on microbial metabolism-epigenetic axis and the pharmacological mechanism of the formula with the same origin of medicine and food to regulate damp-heat constitution

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Zhang Shujun

Study leader：

Li Yingshuai

Applicant telephone：

+86 1880377932

Study leader's telephone：

+86 136 8141 0020

Applicant Fax：

Study leader's fax：

Applicant E-mail：

2415446850@qq.com

Study leader's E-mail：

liyingshuai2013@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Liangxiang Campus of Beijing University of Traditional Chinese Medicine Sunshine South Street Fangshan District Beijing

Study leader's address：

Beijing University of Traditional Chinese Medicine No. 11 North Third Ring East Road Chaoyang District Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

School of Traditional Chinese Medicine Beijing University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2023BZYLL1013

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Beijing University of Chinese Medicine

Date of approved by ethic committee：

2024/3/4 0:00:00

Contact Name of the ethic committee：

Zhao Lihong

Contact Address of the ethic committee：

Liangxiang Campus of Beijing University of Traditional Chinese Medicine Sunshine South Street Fangshan District Beijing

Contact phone of the ethic committee：

+86 134 2639 5469

Contact email of the ethic committee：

llbgs@bucm.edu.cn

Primary sponsor：

National Institute of TCM Constitution and Preventive Medicine

Primary sponsor's address：

Beijing University of Traditional Chinese Medicine No. 11 North Third Ring East Road Chaoyang District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

National Institute of TCM Constitution and Preventive Medicine

Address：

Beijing University of Traditional Chinese Medicine No. 11 North Third Ring East Road Chaoyang District Beijing

Source(s) of funding：

National Natural Science Foundation of China

Target disease：

Hyperuricemia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Through the research of this project the risk of damp-heat constitution HUA and the role of damp-heat regulating body prescription in the treatment of diseases were clarified. Multi-omics integrated analysis was used to construct a deep learning model for the early warning of diseases related to damp heat constitution susceptibility and purine metabolism disorders

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Over 18 years old, male or female; (2) Those who meet the criteria for determining damp and hot constitution. Criteria for judging damp-heat constitution: 40 points for damp-heat quality transformation score ≥ (30 points <for other biased constitution transformation scores); (3) Routine physical examination is normal or there is no other clear disease diagnosis; (4) Lived in Beijing in the past 2 years; (5) Know and understand the content of this study, and voluntarily sign the informed consent form.

Exclusion criteria：

(1) Women who are menstruating, lactating, or pregnant; (2) Use of antibiotics in the past 1 month; (3) Surgical experience or history of severe trauma in the past 1 month; (4) The scale judges that it belongs to the sub-healthy population; (5) Circulatory, respiratory, digestive, urinary, blood, endocrine and other medical and surgical diseases found or suspected during the first health examination; (6) Functional gastrointestinal diseases and mental and psychological diseases found or suspected by medical history and physical examination; (7) Engage in work that has been exposed to harmful substances for a long time; (8) Engaging in long-term night shift work or long-term circadian rhythm reversal; (9) Participating in other clinical trials.

Study execute time：

From 2023-03-01

To      2026-12-31

Recruiting time：

From 2024-03-16

To      2025-06-30

Interventions：

50

Group：

TEST

Sample size：

Intervention：

treated with same origin of medicine and food to regulate damp-heat constitution twice a day one bag in the morning and one bag in the evening taken with water and the course of treatment is 8 weeks.

Intervention code：

50

Group：

CONTRO

Sample size：

Intervention：

treated with placebo twice a day one bag in the morning and one bag in the evening taken with water and the course of treatment is 8 weeks.

Intervention code：

Total sample size ： 100

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Ren An Hospital

Level of the institution：

Primary

Outcomes：

Outcome：

Health Status Score Sheet

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Height and weight

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

routine blood test

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

electrocardiogram

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

fasting low-density lipoprotein cholesterol

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood uric acid

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

urine routine

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Blood pressure

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Liver function tests

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Four items of myocardial enzyme spectrum

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Blood creatinine

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

fasting total cholesterol

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Urine creatinine

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Kidney function tests

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

fasting high-density lipoprotein cholesterol

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Damp-heat constitution score

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

stool routine

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

fasting triglycerides

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

fasting blood glucose

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

adverse reactions and adverse events

Type：

Adverse events

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

stools

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Simple randomization was used in this study. The GCP designated statistical expert of the National Institute of TCM Constitution and Prevention of Disease Beijing University of Chinese Medicine was responsible for the randomization protocol. The statistical software generates random numbers and the corresponding therapeutic drugs of random numbers. Specific randomization process documents will be kept as required for the sealing of the blind bottom. The drug number is 1-118.

Blinding：

The study was conducted in a blinded manner (investigator subject and evaluator) and was conducted by a statistical expert appointed by the GCP Center of The blinding process is recorded and saved.the National Institute of TCM Constitution and Prevention of Disease Beijing University of Chinese Medicine. The blind persons of the randomization preparation unit and the persons who is irrelevant to the trial participated in the field blind preparation of drugs and the formed drug numbers were pasted on the labels.

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

No share the raw data

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case record form was used for collection and management.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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