Effects of Jia Wei Dachaihu Tang on gut microbiota and inflammatory markers in patients with overweight or obesity: a randomized, controlled, double-blinded trial

Phase 1

Recruiting

• Conditions: obesity or overweight

• Registration Number: ITMCTR2100004681
• Lead Sponsor: Hospital of Chengdu University of Traditional 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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Over 18 years to under 65 years of age;
2. Body mass index with >= 25.0 kg/m2(overweight/ obese);
3. Able and willing to provide informed consent and comply with study procedures.

Exclusion Criteria

1.Patients with the endocrine disease that may affect body weight, such as hypothyroidism, Cushing's syndrome, or those with thyroid-stimulating hormone concentration < 0.1 uIU/ml or > 10.0 uIU/ml.
2.Subjects who are already on a diet or undertaking heavy exercise for weight control purposes.
3.Subjects who have undergone surgical procedures for weight control.
4.Patients with a history of neurological or psychological disease or currently suffering from such diseases (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.)
5.Patients with a history or existence of eating disorders such as anorexia nervosa or bulimia nervosa, etc.
6.Patients with experience of medications that could have an effect on weight within last 3 months such as appetite suppressant, laxative, or oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, or medications affecting absorption, metabolism, and excretion.
7.Subjects who diagnosed with diabetes or other metabolic health disturbances.
8.Patients who have used other clinical trial drugs within 3 months.
9.Subjects who have had weight changes > 10% of their previous weight within the last 6 months.
10.Those whose aspartate transaminase or alanine transaminase exceeds five times the normal upper limit (200 IU/L).
11.Kidney dialysis patients or those with creatinine concentration more than twice the normal upper limit.
12.Those who are in seriously unstable medical condition, such as cardiovascular disease, respiratory disease, gastrointestinal disease, hepatobiliary disease, metabolic disease, endocrine disease, renal disease, or problems in the urinary reproductive system and nervous system.
13.Those who have had a diagnosis or have been treated for malignant tumors within the last 5 years.
14.Women who are pregnant, planning to become pregnant, or lactating, or subjects who do not agree to use effective methods of contraception during the clinical trial (Oral contraceptives are not allowed during the clinical trial.).
15.Receiving medications or supplements that could affect gut microbiota during the last 3 months(examples: antibiotics, probiotics, prebiotics, laxatives, etc.).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
body mass index (BMI);waist circumference (WC);

Secondary Outcome Measures

Name	Time	Method
HOMA-IR;gut microbiota;Body composition;inflammatory markers;Health-related quality of life (HRQoL) questionnaire score;blood lipid;Assessments of appetite;