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Evaluating the Safety and Efficacy of Euiiyin-tang on Obesity

13. juni 2018 opdateret af: Seong-Gyu Ko, Kyunghee University Medical Center

A Double Blind, Randomized, Multicenter, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Euiiyin-tang on Obese Patients

The hypothesis of this study is obese patient with Euiiyin-tang for 12 weeks will show a superior reduction compared to those taking the placebo.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study has two arms, Euiiyin-tang and placebo group. Inclusion of 80 patient each arm. They will be screened at first visit. At the baseline, that is the second visit, they will be evaluated each outcomes including weight, waist circumference, lipid profile (total cholesterol, triglyceride), CRP (C-reactive protein), visceral fat area and subcutaneous fat area using abdominal computed tomography (CT), questionnaires of QoL (Quality of Life) and eating attitudes, etc. The Euiiyin-tang will provide to the patients from the baseline, it contains 4 weeks of serving. After 4 weeks, the visit 3, the evaluation procedure will be repeated except lipid profile, CRP, abdominal CT. Another Euiiyin-tang of 4 weeks will be given to the patient. The visit 4, 4 weeks after the visit 3, the same procedure will be repeated. The visit 5, 12 weeks after from the baseline, the patient will be evaluated including weight, waist circumference, lipid profile, CRP, visceral fat area and subcutaneous fat area using abdominal computed tomography, questionnaires of QoL and eating attitudes, etc.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

149

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
      • Incheon, Korea, Republikken, 405-760
        • Gachon University Gil Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. Women aged 18-65 years old
  2. Patients applying to one of the followings 2.1. BMI 30kg/m2 or over 2.2. BMI 27-29.9kg/m2 with hypertension in a proper treatment and blood pressure controlled (SBP ≤ 145mmHg, DBP ≤ 95mmHg) 2.3. BMI 27-29.9kg/m2 with non-insulin-dependent diabetes mellitus and fasting blood glucose < 7.8mmol/L(140mg/dL) 2.4. BMI 27-29.9kg/m2 with hyperlipidemia in a proper treatment 2.5. BMI 27-39.9kg/m2 and Total cholesterol 236mg/dL or over or Triglyceride 150mg/dL or over at screening
  3. Agreed to low-calorie diet during the trial
  4. Written informed consent of the trial

Exclusion Criteria:

  1. Endocrine disease such as hypothyroidism, Cushing's syndrome, etc.
  2. Heart disease (heart failure, angina pectoris, myocardial infarction)
  3. Uncontrolled hypertension (SBP > 145 mmHg or DBP > 95 mmHg)
  4. Malignant tumour or lung disease
  5. Cholelithiasis
  6. Severe renal disability (SCr > 2.0 mg/dL)
  7. Severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], alkaline phosphatase)
  8. Non-insulin-dependent diabetes mellitus and fasting blood sugar 7.8mmol/L (140 mg/dL) or over
  9. Narrow angle glaucoma
  10. History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.)
  11. History of stroke or temporary ischemic cardioplegia
  12. History or existence of eating disorder such as anorexia nervosa or bulimia nervosa, etc.
  13. Use of medication that could have effect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medication having effect on absorption, metabolism, excretion)
  14. Use of β--blocker or diuretic as hypertension medication within last 3 months
  15. Use of medication for central nervous system or central active weight reduction medication
  16. Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
  17. Difficult to measure anthropometric dimensions because of anatomical change such as resection
  18. Surgical history for weight reduction; bariatric surgery, etc.
  19. Unable to follow instructions of the trial as judged by investigator
  20. Women who were pregnant, lactating, planning a pregnancy or women of childbearing age who do not agree to proper contraception (birth-control pill, hormone implant, IUD, spermicide, condom, abstinence, etc.) (Women of childbearing age indicate within 2 years of menopause who did not receive hysterectomy, bilateral tubal ligation, bilateral oophorectomy, etc.)
  21. Use of other investigational product within last 1 month
  22. Reduction over 10% of the previous weight within 6 months
  23. Decided to stop smoking within last 3 months; however, keeping irregular smoking habit

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Euiiyin-tang
powder type, 3 times per day before the meal, 12 weeks total
Medicin: Euiiyin-tang
Korean medicinal herbal drug
Placebo komparator: Placebo
powder type, 3 times per day before the meal, 12 weeks total
Medicin: Placebo
Placebo drug, same odor and formula as Euiiyin-tang

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Weight reduction
Tidsramme: between baseline and 12 weeks
between baseline and 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
C-reactive protein (CRP)
Tidsramme: baseline and 12 weeks
baseline and 12 weeks
Blood pressure
Tidsramme: baseline, 4 weeks, 8 weeks, and 12 weeks
baseline, 4 weeks, 8 weeks, and 12 weeks
Blood glucose
Tidsramme: baseline and 12 weeks
baseline and 12 weeks
Waist/hip ratio
Tidsramme: 4 weeks, 8 weeks, and 12 weeks
4 weeks, 8 weeks, and 12 weeks
Waist circumference
Tidsramme: baseline, 4 weeks, 8 weeks, and 12 weeks
baseline, 4 weeks, 8 weeks, and 12 weeks
Korean Obesity-related Quality of Life scale
Tidsramme: baseline and 12 weeks
baseline and 12 weeks
Korean version of Eating Attitudes Test-26
Tidsramme: baseline and 12 weeks
baseline and 12 weeks
Total cholesterol
Tidsramme: baseline and 12 weeks
baseline and 12 weeks
Triglyceride
Tidsramme: baseline and 12 weeks
baseline and 12 weeks
Visceral fat area
Tidsramme: baseline and 12 weeks
Using abdominal computed tomography
baseline and 12 weeks
Subcutaneous fat area
Tidsramme: baseline and 12 weeks
Using abdominal computed tomography
baseline and 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kyunghee University Medical Center

Samarbejdspartnere

Korea Health Industry Development Institute
Gachon University Gil Medical Center

Efterforskere

  • Ledende efterforsker: Yoon-kyung SONG, KMD, Gachon University Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2013

Primær færdiggørelse (Faktiske)

1. februar 2015

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

2. november 2012

Først indsendt, der opfyldte QC-kriterier

8. november 2012

Først opslået (Skøn)

9. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HP001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Euiiyin-tang

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Sponsorer og samarbejdspartnere

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CROs in Malaysia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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