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Gut Microbiota-Based Clinical Curative Effects and Mechanism Research of Preventive Treatment of Prediabetes and Borderline Hyperlipidemia by Adjusting Phlegm-dampness Constitution with Hua Tan Qu Shi Decoction

Gut Microbiota-Based Clinical Curative Effects and Mechanism Research of Preventive Treatment of Prediabetes and Borderline Hyperlipidemia by Adjusting Phlegm-dampness Constitution with Hua Tan Qu Shi Decoction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020674
Enrollment
Unknown
Registered
2019-01-12
Start date
2019-01-31
Completion date
Unknown
Last updated
2020-03-09

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

Conditions

prediabetes

Interventions

balance constitution (BC):without
phlegm-dampness constitution 1 (PDC1):Hua Tan Qu Shi decoction + routine diet guidance
phlegm-dampness constitution 2 (PDC2):placebo + routine diet guidance
phlegm-dampness constitution with prediabetes 1 (PDCD1):Hua Tan Qu Shi decoction + routine diet guidance
phlegm-dampness constitution with prediabetes 2 (PDCD2):placebo + routine diet guidance
phlegm-dampness constitution with borderline hyperlipidemia 1 (PDCH1):Hua Tan Qu Shi decoction + routine diet guidance
phlegm-dampness constitution with borderline hyperlipidemia 2 (PDCH2):placebo + routine diet guidance
phlegm-dampness constitution with hyperlipidemia 3(PDCH3):Hua Tan Qu Shi decoction + routine diet guidance
phlegm-dampness constitution with hyperlipidemia 4(PDCH4):placebo + routine diet guidance

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Classified balance constitution and phlegm-dampness constitution according to the China Association of Chinese Medicine (CACM) standards 2009 (Classification and Determination of Constitution in Traditional Chinese Medicine, No:ZZYXH/T157-2009). Diagnosed prediabetes patients according to Chinese Diabetes Society (CDS) standards 2017 (China Guideline for Type 2 Diabetes). Diagnosed borderline hyperlipidemia and hyperlipidemia patients according to Joint Committee on Revision of China Guideline for Prevention and Treatment of Adult Hyperlipidemia (National Center for Cardiovascular Diseases,NCCD/Chinese Society of Cardiology,CSC/Chinese Diabetes Society,CDS/Chinese Society of Endocrinology, CSE/Chinese Society of Laboratory Medicine, CSLM) standards 2016 (China Guideline for Prevention and Treatment of Adult Hyperlipidemia (2016 Revision)); 2. Aged 18-50 years old male and female; 3. Han population living in the local more than five years and having constant residence; 4. BMI of balance constitution should range from 18.5 to 24. BMI of phlegm-dampness constitution should not less than 24; 5. Having good memory, motility, self-care ability and healty mentality; 6. Agreeing to join the study and signing the informed consent; 7. Having good compliance: no business trips, no outdoor dining, regular work and rest time, regular dietary intake, adequate time to participate in this study, having a burning desire to change physical condition, fully understanding of 'preventive treatment of metabolic diseases by adjusting phlegm-dampness constitution with Chinese Medicine decoctions' and 'enterogenous theory of chronic diseases'; 8. Having not attend any other research projects currently or in 4 months after join this research.

Exclusion criteria

Exclusion criteria: 1. Antibiotic usage in last 3 months. Other foods or drugs affecting intestinal flora usage in last 3 months, e.g. gastrointestinal prokinetic agents, micro-ecological modulators; 2. Received weight-loss drugs or surgical methods therapy in last 3 months, e.g. appetite inhibitors fluorophenylalamide, thyroid hormones, progesterone, laxatives and traditional Chinese medicine ingredients for weight loss; 3. Received drug therapy aim at the following diseases, e.g. cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, urocystitis or hyperthyreosis; 4. Pregnancy, planning to become pregnant, lactation or menopausal women (high risk population of coronary heart disease); 5. Excessive drinking (drinking more than 5 times in one week and drinking more than 100g white liquor, 250g yellow rice wine or 2500ml of beer); 6. Received gastrointestinal surgery except for appendicitis or hernia surgery; 7. With mental diseases; 8. With other severe diseases in heart, liver, brain, lung, kidney or blood, e.g. cancer, coronary heart disease, myocardial infarction and cerebral apoplexy, except for nonalcohol fatty liver disease; 9. With chronic persistent hepatitis, severe hepatic diseases, e.g. liver cirrhosis or cooccurence of positive HBsAg and abnormal hepatic transaminase; 10. With IBD, Cushing's syndrome or pituitary dysfunction; 11. With infectious disease, e.g. phthisis and AIDS.

Design outcomes

Primary

MeasureTime frame
Score of Chinese Medicine Constitution Scale;FPG;2hPG;TG;TC;LDL-C;HDL-C;

Secondary

MeasureTime frame
HbA1c;FINS;INS;Apo-a;Apo-ß;Weight;Body Fat Percentage;Blood Pressure;Waistline;Hipline;W/H;Body Mass Index;HOMA-IR Index;Insulin Sensitivity Index;Intestinal Secretion Peptide;Inflammatory Factor;LPS;The composition of gut microbiota;The function of gut microbiota;The metabolism of gut microbiota;

Countries

China

Contacts

Public ContactWang Qi

Beijing University of Chinese Medicine

wangqi710@126.com+86 13901003796

Outcome results

None listed

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