PMID- 30486682
OWN - NLM
STAT- MEDLINE
DCOM- 20211001
LR  - 20211001
IS  - 1525-6014 (Electronic)
IS  - 0148-0545 (Linking)
VI  - 44
IP  - 2
DP  - 2021 Mar
TI  - Safety and tolerability of carvacrol in healthy subjects: a phase I clinical 
      study.
PG  - 177-189
LID - 10.1080/01480545.2018.1538233 [doi]
AB  - This study was designed to assess safety and tolerability of carvacrol in healthy 
      individuals. Subjects were randomly divided into two groups receiving 1 and 
      2 mg/kg/day carvacrol. Before and after carvacrol administration, routine blood 
      and urine laboratory tests and spirometry were performed for all participants. 
      The results showed that one-month treatment with carvacrol did not significantly 
      affect the measured variables. In the group receiving 1 mg/kg/day carvacrol, 
      calcium, erythrocyte sedimentation rate (ESR), mean cell volume (MCV), hemoglobin 
      (Hb), and hematocrit (HCT) levels were significantly reduced but creatinine 
      phosphokinase (CPK) was significantly increased, after treatment compared to 
      baseline values (p < 0.05-p < 0.001). There was significant reductions in 
      high-density lipoprotein cholesterol (HDL), total bilirubin, amylase, iron, red 
      blood cells (RBC) count, and HCT after one-month treatment with 2 mg/kg/day 
      carvacrol compared to pretreatment values (p < 0.05-p < 0.01). Although, 
      triglyceride (TG), phosphorus, lactate dehydrogenase (LDH), prothrombin time 
      (PT), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin 
      concentration (MCHC) were significantly increased after treatment with carvacrol 
      1 mg/kg/day (p < 0.05-p < 0.001), all post-treatment measured parameters were 
      within normal range. Treatment with carvacrol 2 mg/kg/day for one month increased 
      FEV(1) (p < 0.05). Nevertheless, there was no significant difference in measured 
      variables except LDH, MCH, MCHC, and MCV (p < 0.05-p < 0.01), between the two 
      groups. The results of this phase I study regarding carvacrol effects on healthy 
      subjects, showed clinical safety and tolerability for this agent.
FAU - Ghorani, Vahideh
AU  - Ghorani V
AD  - Pharmaceutical Research Center, Mashhad University of Medical Sciences, Mashhad, 
      Iran.
AD  - Department of Physiology, School of Medicine, Mashhad University of Medical 
      Sciences, Mashhad, Iran.
FAU - Alavinezhad, Azam
AU  - Alavinezhad A
AD  - Department of Physiology, School of Medicine, Mashhad University of Medical 
      Sciences, Mashhad, Iran.
AD  - Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, 
      Mashhad, Iran.
FAU - Rajabi, Omid
AU  - Rajabi O
AD  - Department of Drug and Food Control, School of Pharmacy, Mashhad University of 
      Medical Sciences, Mashhad, Iran.
FAU - Mohammadpour, Amir Hooshang
AU  - Mohammadpour AH
AD  - Pharmaceutical Research Center, Pharmaceutical Institute of Technology, Mashhad 
      University of Medical Sciences, Mashhad, Iran.
AD  - Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of 
      Medical Sciences, Mashhad, Iran.
FAU - Boskabady, Mohammad Hossein
AU  - Boskabady MH
AD  - Department of Physiology, School of Medicine, Mashhad University of Medical 
      Sciences, Mashhad, Iran.
AD  - Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, 
      Mashhad, Iran.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20181129
PL  - United States
TA  - Drug Chem Toxicol
JT  - Drug and chemical toxicology
JID - 7801723
RN  - 0 (Cymenes)
RN  - 9B1J4V995Q (carvacrol)
RN  - EC 1.1.1.27 (L-Lactate Dehydrogenase)
SB  - IM
MH  - Adult
MH  - Cymenes/administration & dosage/*adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Erythrocyte Indices/drug effects
MH  - Female
MH  - Humans
MH  - L-Lactate Dehydrogenase/metabolism
MH  - Male
MH  - Young Adult
OTO - NOTNLM
OT  - Carvacrol
OT  - clinical
OT  - healthy subjects
OT  - safety
OT  - tolerability
OT  - toxicity
EDAT- 2018/11/30 06:00
MHDA- 2021/10/02 06:00
CRDT- 2018/11/30 06:00
PHST- 2018/11/30 06:00 [pubmed]
PHST- 2021/10/02 06:00 [medline]
PHST- 2018/11/30 06:00 [entrez]
AID - 10.1080/01480545.2018.1538233 [doi]
PST - ppublish
SO  - Drug Chem Toxicol. 2021 Mar;44(2):177-189. doi: 10.1080/01480545.2018.1538233. 
      Epub 2018 Nov 29.