Investigating the effects of the herbal medicine Taeeumjowui-tang on obesity and metabolic syndrome risk factors

Not Applicable

Completed

• Conditions: Metabolic syndrome; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN13677132
• Lead Sponsor: Cheonan Oriental Hospital of Daejeon University

Brief Summary

2021 Results article in https://doi.org/10.3390/app11188741 (added 20/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-30
• Study Completion: 2020-05-31
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

1. Aged between 19 and 64.
2. Diagnosed by SCAT (Sasang Constitutional Analysis Tool) as a Taeum type person (Taeum-in).
3. BMI of 23 or more
4. Meet the criteria of waist circumference, and one or more other metabolic syndrome criteria.
5. Blood pressure, diabetes, and hyperlipidemia are controlled stably so do not need additional medical prescriptions.
6. Able to communicate with researchers and are able to follow the test compliance.

Exclusion Criteria

1. Meet the following criteria
1.1. HbA1c 8.5% or more
1.2. Fasting triglyceride : TG = 400
1.3. LDL-chol. = 190
1.4. Blood pressure =160/100mmHg
2. History of severe renal impairment (renal failure, nephrotic syndrome, glomerular disease), dialysis history, or Cr level more than twice the normal upper limit.
3. History of severe liver disease (cirrhosis, liver cancer), or AST or ALT greater than 2.5 times the normal level.
4. Acute phase or urgent angina pectoris, myocardial infarction, stroke, cardiac or cerebrovascular disease.
5. Gastrointestinal problems(anorexia, nausea, vomiting, etc.) unlikely to be able to participate under the researcher’s judgement.
6. Those who have participated in other interventional clinical trials within the last 3 months.
7) Artificial weight loss of more than 10% of the total weight within 6 weeks.
8) Those with neuropsychiatric disorders.
9) Those with excessive alcohol consumption (more than 14 bottles per week)
10) Allergic to test drug ingredients
11) Those who plan to participate in other clinical trials during the course of this trial.
12) Currently taking medication for hyperthyroidism, or TSH level more than 1.5 times the normal upper limit.
13. Diagnosed with malignant tumor or received chemotherapy within 5 years.
14. Those who have taken the following medications within 3 months:
14.1. Ephedrine
14.2. MAO inhibitors
14.3. Thyroid medications (thyroxine, lyothionine)
14.4. Catecholamines (epinephrine, isoprenaline)
14.5. Xanthines (theophylline, dipropyline).
15. Changes in medical prescriptions for blood pressure, diabetes, hyperlipidemia, obesity within 3 months.
16. Other serious medical conditions or symptoms unlikely to be able to participate under the researcher’s judgement.
17. Hidrosis
18. Excessive weakness, or in the aftermath of a disease.
19. Severe urinary disorders
20. Genetic problems such has galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
21. Those who are expected to have dietary changes during the clinical trial
22. Pregnant or the possibility of pregnancy, or nursing mother.
23. Those who have a history of elevated blood glucose by taking ephedrine
24. Those who have taken drugs that can affect body weight such as appetite suppressants, laxatives (without prescription) or oral steroids, thyroid hormones, amphetamines, ciproheptadine, phenodiazines, or drugs that affect absorption or metabolism within 3 months.
25. Those who have undergone surgical surgery for weight loss such as gastroplasty.

Study & Design

• Study Type: Interventional
• Study Design: Not specified