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IRCT20171207037777N1 IRCT 2019-04-09 Mashhad University of Medical Sciences Alternative medicine in thyroid eye disease (TED) Assessment of therapeutic effects of Curcumin & Crucina on thyroid eye disease (TED) 2018-11-22 anticipated 90 Complete https://irct.ir/trial/33132 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First of all the patients allocated in 2 groups, according to indication for steroid use or not (depending to clinical activity score as described in proposal). Then by simple randomization (by drawing a ballot through a bottle containing lots labeled A, B or C), the patients allocated in groups A, B or C by lottery, Blinding description: The drugs packed in similar bottles labeled A, B or C. The patient will receive one pack of drug. The usage information is in the bottle so that the clinician hasn't any information about the contents of the packages. In the lab, the blood samples were reserved under the name of patients but the reporter of the results will be unaware from the drugs used by the patients. 3 Thyroid eye disease. Intervention 1: Intervention group 1: Steroid plus curcumin 1 capsule/day for 2 months (Sina Curcumin 80 mg capsule, Exir Nano Sina, Mashhad, Iran). Intervention 2: Intervention group 2: Steroid plus crocin (two 15 mg tablet daily for 2 months , Krocina, Samisaz Co. Mashhad, Iran). Intervention 3: Intervention group 3: curcumin, 1 capsule/day for 2 months (Sina Curcumin 80 mg capsule, Exir Nano Sina, Mashhad, Iran)without steroid. Intervention 4: Intervention group 4: crosin (two 15 mg tablet daily for 2 months , Krocina, Samisaz Co. Mashhad, Iran) without steroid. Intervention 5: Control group 1: placebo (polysorbate 80, Exir Nano Sina, Mashhad, Iran) with steroid for 2 months. Intervention 6: Control group 2: placebo (polysorbate 80, Exir Nano Sina, Mashhad, Iran) without steroid for 2 months. Yes - There is a plan to make this available What will be shared: Demographic data, clinical and serologic results When: After Sep. 2020 To whom: Academic researchers Conditions: Any publications should include researchers of this study and also refer to published articles Where to obtain: Aliakbar Sabermoghaddam Ranjbar, Khatam al anbia eye hospital How to obtain: E mail to corresponding researcher including necessary data and how to use Comments:
public Aliakbar Sabermoghaddam Ranjbar
No. 16, Edalat 21 Ave., Ahmadabad st.
Mashhad Iran (Islamic Republic of) 9176614889 +98 51 3845 6406 saberaa@mums.ac.ir Mashhad University of Medical Sciences scientific Aliakbar Sabermoghaddam Ranjbar
No 16 , Edalat 21, Ahmadabad st,
Mashhad Iran (Islamic Republic of) 9176614889 +98 51 3845 6406 saberaa@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Thyroid eye disease with clinical activity score (CAS) equal to 1 or more no limit no limit Both No consent Poor coopration E05.0 Thyrotoxicosis with diffuse goiter Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Placebo Intervention group 1: Steroid plus curcumin 1 capsule/day for 2 months (Sina Curcumin 80 mg capsule, Exir Nano Sina, Mashhad, Iran) Intervention group 2: Steroid plus crocin (two 15 mg tablet daily for 2 months , Krocina, Samisaz Co. Mashhad, Iran) Intervention group 3: curcumin, 1 capsule/day for 2 months (Sina Curcumin 80 mg capsule, Exir Nano Sina, Mashhad, Iran)without steroid Intervention group 4: crosin (two 15 mg tablet daily for 2 months , Krocina, Samisaz Co. Mashhad, Iran) without steroid Control group 1: placebo (polysorbate 80, Exir Nano Sina, Mashhad, Iran) with steroid for 2 months Control group 2: placebo (polysorbate 80, Exir Nano Sina, Mashhad, Iran) without steroid for 2 months Clinical activity of eye involvement. Timepoint: Before, 1 & 2 months after initiation of intervention. Method of measurement: Clinical evaluation. Serologic level of IL2. Timepoint: Before and 2 months after initiation of intervention. Method of measurement: ELISA. Serologic level of TNFa. Timepoint: Before and 2 months after initiation of intervention. Method of measurement: ELISA. Mashhad University of Medical Sciences Approved 2018-06-27 Ethics committee of Mashhad university of medical sciences N0. 51, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)