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IRCT2015123025772N1 IRCT 2016-04-08 Vice chancellor for Research, Mashhad University of Medical Science Evaluation of the effect of a herbal mixture on non alcoholic fatty liver disease Evaluation of the effects of a Polyherbal compound on severity of steatosis and the levels of blood lipids and liver enzymes in patients with nonalcoholic fatty liver disease: A randomized controlled trial 2016-04-20 anticipated 64 Complete https://irct.ir/trial/21520 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization. N/A Non alcoholic fatty liver desease. The treatment group received herbal capsules containing 400 mg of the mixture of Anethum graveolens, Citrus bigardia, Cynara scolymus, Portulaca oleracea, and Silybum marianum (2 capsules, thrice daily, for two months)> Both treatment and control group were advised to take healthy diet and exercise.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Seyyed Abbas Zojaji
Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3502 4824 zojajclub@gmail.com Zojaj darman toos Pharmaceutical Company scientific Ahmad Ghorbani
Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2278 ghorbania@mums.ac.ir Mashhsad Medical School, Pharmacological Research Center of Medicinal Plants Iran (Islamic Republic of) patients with nonalcoholic fatty liver disease with grade ≥ 2 of steatosis on sonography or grade 1 of steatosis + elevated serum alanine transaminase level 18 years 70 years Both Having special or chronic disease like auto immune diseases, hypothyroidism, lupus, renal dysfunction, cancers, heart diseases, and severe infections Cirrhosis or Hepatitis B and C Pregnancy and lactation Unwillingness to continue treatment with herbal compound K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs The treatment group received herbal capsules containing 400 mg of the mixture of Anethum graveolens, Citrus bigardia, Cynara scolymus, Portulaca oleracea, and Silybum marianum (2 capsules, thrice daily, for two months)> Both treatment and control group were advised to take healthy diet and exercise. Alanine transaminase (ALT). Timepoint: Before intervention, two month after intervention. Method of measurement: Blood examination. Steatosis of liver. Timepoint: Before intervention, two month after intervention. Method of measurement: Sonography. Aspartate transaminase (AST). Timepoint: Before starting study and 2 months after starting study. Method of measurement: Blood analysis (kit). Fasting blood glucose. Timepoint: Before starting study and 2 months after starting study. Method of measurement: Blood analysis (kit). Serum lipids. Timepoint: Before starting study and 2 months after starting study. Method of measurement: Blood analysis (kit) for total cholesterol and triglyceride. The Zojaj Darman Toos Pharmaceutical Company Vice chancellor for Research, Mashhad University of Medical Science The Zojaj Darman Toos Pharmaceutical Company Approved 2015-06-17 Ethics Committee of Mashhad University of Medical Science Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Pardis campus, Azadi square, Mashhad City, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)