]>
IRCT20140715018490N6 IRCT 2018-11-13 Fasa University of Medical Sciences Effect of compounds (Thymus daenensis, Matricaria chamomilla L., Achillea santolina & Satureja bachtiarica Bunge) on the treatment of diabetes To evaluate the complementary efficacy of a compound herbal drug (Thymus daenensis, Matricaria chamomilla L. , Achillea santolina & Satureja bachtiarica Bunge) in patients with diabetes type II 2018-08-06 anticipated 105 Complete https://irct.ir/trial/30296 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random table with blocks of 6. In this method; using an existing electronic software such as "https://www.sealedenvelope.com/simple-randomiser/v1/lists", we create a randomized list of 6 blocks for the 3 study groups. In this list, letters A, B, and C as three groups of this study are randomly distributed in groups of 6. And on the basis of this list, medications are given to the patients respectively, Blinding description: Participants, researchers and data analyzer were blinded to the study groups. We made the placebo and therapeutic capsules like each other and labeled them by a letter -from A to C. 3 Diabetes Mellitus. Intervention 1: Intervention group 1: In addition to anti diabetic drugs, a coded bottle containing type 1 diabetic capsules (each capsule containing dried aqueous extract of 100 mg of Thymus, 100 mg of chamomile, 200 mg of Achillea and 100 Mg Satureja), is given to the patients. This means that: besides their anti diabetic drugs, they should consume 2 other capsules per day (one in the morning and one in the evening) for 3 months. Intervention 2: Intervention group 2: In addition to anti diabetic drugs, a coded bottle containing type 2 diabetic capsules (each capsule containing dried hydro-alcoholic extract of 100 mg of Thymus, 100 mg of chamomile, 200 mg of Achillea and 100 Mg Satureja), is given to the patients. This means that: besides their anti diabetic drugs, they should consume 2 other capsules per day (one in the morning and one in the evening) for 3 months. Intervention 3: Control group: In addition to anti diabetic drugs, a coded bottle containing placebo capsules (each capsule containing 500 mg of caramelized corn flour), is given to the patients. This means that: besides their anti diabetic drugs, they should consume 2 other capsules per day (one in the morning and one in the evening) for 3 months. Yes - There is a plan to make this available What will be shared: Data and results of analysis will be published in a paper. When: After the end of study. To whom: All of those who have access to the article. Conditions: The editor in chief, if necessary. Where to obtain: Vice chancellor for research affair of Fasa University of Medical Sciences How to obtain: Asking from Vice chancellor for research affair of Fasa University of Medical Sciences Comments:
public Neda Jamshidi Gorki
No. 10, 4th alley, Reis-ali Delvar street, Shahrak Golestan
shiraz Iran (Islamic Republic of) 7189935335 +98 71 3620 5451 n.jamshidi69@gmail.com Fasa University of Medical Sciences scientific Massih Sedigh Rahimabadi
Ghazal II, Paeez st., Pasargad Ave
Shiraz Iran (Islamic Republic of) 123456789 +98 71 3825 6275 massih21@yahoo.com Fasa University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Presence of diabetes (FBS>126 mg/dl) To have a FBS less than 270 and HgbA1c more than 5.6 Age between 30 to 65 Not to have any additional systemic diseases like; liver, renal, rheumatologic diseases or hypertension Not to consume any anti-diabetic or corticosteroid drugs 2 weeks before the study Not to drink alcohol or use opium To have a weight between 55-100 To have a BMI between 18 to 35 30 years 65 years Both Not agree to participate in the study. To have a FBS more than 270 mg/dl Consuming corticosteroid drugs during the study Presence of any side effects E11 Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: In addition to anti diabetic drugs, a coded bottle containing type 1 diabetic capsules (each capsule containing dried aqueous extract of 100 mg of Thymus, 100 mg of chamomile, 200 mg of Achillea and 100 Mg Satureja), is given to the patients. This means that: besides their anti diabetic drugs, they should consume 2 other capsules per day (one in the morning and one in the evening) for 3 months. Intervention group 2: In addition to anti diabetic drugs, a coded bottle containing type 2 diabetic capsules (each capsule containing dried hydro-alcoholic extract of 100 mg of Thymus, 100 mg of chamomile, 200 mg of Achillea and 100 Mg Satureja), is given to the patients. This means that: besides their anti diabetic drugs, they should consume 2 other capsules per day (one in the morning and one in the evening) for 3 months. Control group: In addition to anti diabetic drugs, a coded bottle containing placebo capsules (each capsule containing 500 mg of caramelized corn flour), is given to the patients. This means that: besides their anti diabetic drugs, they should consume 2 other capsules per day (one in the morning and one in the evening) for 3 months. FBS. Timepoint: At the beginning of intervention, after 4 weeks then after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. HgbA1C. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. کلسترول تام. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. BS2pp. Timepoint: At the beginning of intervention, after4 weeks then after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. LDL. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. HDL. Timepoint: At the beginning of intervention and after 12 weeks from the beginning. Method of measurement: Venous blood sampling. SGOT. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. Alp. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. TG. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. SGPT. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. PPARγI gene expression. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. IGFBP-2 gene expression. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. IGFR gene expression. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. IGF-1 gene expression. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. IR gene expression. Timepoint: At the beginning of intervention and after 12 weeks from the beginning of intervention. Method of measurement: Venous blood sampling. Satisfaction of patients. Timepoint: 3 months after recruitment. Method of measurement: visual analog scale. Tolerance. Timepoint: 3 months after recruitment. Method of measurement: visual analog scale. Temperament. Timepoint: At the beginning of the study. Method of measurement: Questionnaire. Drug side effects. Timepoint: 3 months after recruitment. Method of measurement: Questionnaire. Fasa University of Medical Sciences Approved 2639-01-21 Ethics Comimtte of Fasa University of Medical Sciences Ebn-Sina square fasa Fars Iran (Islamic Republic of)