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An exploratory study of 3 different complex herbal medicines for Sasang constitution types through microbiota and metabolomic approach

An exploratory study of 3 different complex herbal medicines for Sasang constitution types through microbiota and metabolomic approach : A Randomized, Double-blind Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0001227
Enrollment
45
Registered
2014-09-15
Start date
2014-07-02
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : randomized participants were prescribed to either Taeumjowee-tang, Yanggyuksanhwa-tang, Palmulgunja-tang to administer twice a day at each visit for total 4 weeks.

Sponsors

Dongguk University Ilsan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 15 typical constitution patients who were selected in 2013 clinical trials each groups(total 45 patients) 2) Among all men and women aged between 19 and 65 years 3) patients who do not correspond to the exclusion criteria

Exclusion criteria

Exclusion criteria: 1) patients with any condition that can affect weight gain such as hypothyroidism, cushing syndrome 2) heart disease(heart failure, angina pectoris, myocardial infarction) 3) cancer or lung disease 4) liver dysfunction(ALT(Alanine Aminotransferase), AST(Aspartate Aminotransferase) = 2.5 fold upper limit of normal) 5) patients who are diagnosed with cholelithiasis 6) severe renal dysfunction (Cr >2.0mg/dl) 7) Narrow angle glaucoma 8) neuropsychiatric diseases(schizophrenia, epilepsy, alcoholism, drug addiction, anorexia nervosa, hyperphagia) 9) past history of stroke, transient ischemic heart disease 10) eating disorder such as anorexia nervosa and bulimia nervosa 11) patients who have taken anorexiants, relievers(without prescription), oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, or any other medication within 3 months that can affect absorption, metabolism, excretion which can affect on weight. 12) who are on narcotics and neuropsychological drugs for weight reduction 13) other forbidden treatments(insulin, hypogycemic agents, antidepressants, anti serotonin reuptake inhibitor, sodium pentobarbital, antipsychotics, drugs concerned with misuse) 14) patients who underwent anatomical change such as incision which makes it difficult to conduct physical measurements 15) patients who underwent surgeries for weight reduction(gastroplastia) 16) pregnant women, breast feeder, women planning a pregnancy and those who do not agree to use adequate contraception such as oral contraceptives, hormone transplant, IUD, spermicide, condom, celibacy. 17) patients who have taken other medications provided by clinical trial within a month 18) patients who have lost more than 10% of body weight within 6 months 19) patients who are judged to be unacceptable for candidate by person in charge of clinical trial 20) patients who have given up on smoking within past 3 months but who have irregular smoking habit 21) patients who had received antiboitics or probiotics within 1 month

Design outcomes

Primary

MeasureTime frame
difference of intestinal microbiota ratio according to Sasang typology and herbal medicine group ;changes in metabolite pattern was analyzed by LC-MS

Secondary

MeasureTime frame
weight, body composition (body fat mass, muscle mass), waist circumference, blood pressure, BMI;drug reaction according to Sasang typology and herbal medicine group ;blood lipid profile (triglyceride, total cholesterol, HDL cholesterol), blood glucose, amylase, lipase

Countries

Korea, Republic of

Contacts

Public ContactHojun Kim

Dongguk University Ilsan Hospital

Outcome results

None listed

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