]>
IRCT20260822070751N1 IRCT 2026-08-31 Artesh University of Medical Sciences Evaluation of the Antidiabetic Effect of Dietary Supplement( Denazh supplement) Prepared from Oat and Terminalia chebula fruit in Patients with Prediabetes Type 2 Diabetes: A Single-Blind Clinical Trial Evaluation of the Antidiabetic Effect of Dietary Supplement( Denazh supplement) Prepared from Oat and Terminalia chebula fruit in Patients with Prediabetes Type 2 Diabetes: A Single-Blind Clinical Trial 2026-07-23 anticipated 75 Complete https://irct.ir/trial/92726 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: In this study, randomization will be performed individually using block randomization to ensure that the number of participants in each group remains as balanced as possible throughout the allocation process. Statistical software will be used to generate the random sequence. If necessary, blocks of variable sizes may be used to reduce the predictability of allocation. Unit of randomization: The unit of randomization is the individual participant. Stratification variables: Stratified randomization will not be used in this study. Randomization tool: The random sequence will be generated using statistical software, and participants will be allocated to groups based on this sequence. Method of generating the random sequence: A pre-specified random sequence will be generated by an individual independent of the study implementation team. This sequence will be designed based on random blocks and will be used sequentially to allocate participants to the study groups. Allocation concealment: To prevent allocation bias, the random sequence and group allocation information will be concealed from researchers and assessors until the participant enters the study and completes the registration process. Final allocation will be performed by an independent individual using an appropriate allocation concealment methodent: To prevent allocation bias, the random sequence and group assignments will be kept concealed from researchers and assessors until the participant enters the study and the registration process is completed. Final allocation will be performed by an independent person using an appropriate concealment method, Blinding description: Description of study blinding: This study has been designed as a single-blind study. In order to comply with the principles of medical ethics, all participants will be fully informed about the nature of the study, the research process, and its purpose before entering the study, and will sign a written informed consent form. Blinding is limited to concealing the type of intervention (black myrobalan, black seed, or placebo) from the participants. Details of the blinding status of individuals are as follows: Participants: Participants will be unaware of their allocation to the intervention groups (black myrobalan, black seed, or placebo), and the supplements will be prepared to be similar in appearance, color, odor, and packaging. However, participants will be fully aware of the general nature of the study and that they are receiving either a type of herbal supplement or a placebo. Principal investigator and research team: The principal investigator, healthcare personnel, and those responsible for implementing the study will be aware of group allocations in order to monitor patient safety and manage potential adverse events. 3 Prediabetes type2. Intervention 1: Control group: Participants will receive one 6‑g sachet of a placebo daily, matched in appearance and taste to the intervention products. The placebo sachet contains maltodextrin and will be taken orally once daily. Intervention 2: First intervention group: Participants will receive one 6‑g sachet daily containing Terminalia chebula (black myrobalan) powder combined with oat powder. The intervention will be administered orally once daily for 6 weeks. Intervention 3: Second intervention group: Participants will receive one 6‑g sachet daily containing Terminalia chebula extract combined with oat powder. The intervention will be administered orally once daily for 6 weeks. 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 Vahid Hadi
AJA University of Medical Sciences, at the end of Etemadzadeh Street, West Fatemi Street, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۸۵۴۱ +98 937 127 8375 vahidhadi1@gmail.com Artesh University of Medical Sciences scientific Hosein Imani
Tehran University of Medical Sciences (TUMS) Central Headquarters, corner of Ghods Street, Keshavarz Boulevard, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۸۵۴۱ +98 912 138 5088 info6513@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Fasting blood sugar between 100 and 125 Diagnosis of type 2 prediabetes prior to study entry 18 years 70 years Both Suffering from a severe acute or chronic illness Need to use diabetes control medications Known allergy to medicinal herbs, black myrobalan (Terminalia chebula), or oats The volunteer's decision to withdraw from the study R73.03 Prediabetes, prediabetic type2 Placebo Treatment - Drugs Treatment - Drugs Control group: Participants will receive one 6‑g sachet of a placebo daily, matched in appearance and taste to the intervention products. The placebo sachet contains maltodextrin and will be taken orally once daily First intervention group: Participants will receive one 6‑g sachet daily containing Terminalia chebula (black myrobalan) powder combined with oat powder. The intervention will be administered orally once daily for 6 weeks. Second intervention group: Participants will receive one 6‑g sachet daily containing Terminalia chebula extract combined with oat powder. The intervention will be administered orally once daily for 6 weeks. Fasting Blood Sugar (FBS). Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: Fasting blood sugar (FBS), measured after at least 10–12 hours of fasting from a venous blood sample using an enzymatic glucose oxidase method, expressed in mg/dL, at two time points: study initiation (baseline) and the end of week 6. Changes in this variable relative to baseline constitute the primary outcome of the study. Fasting Insulin. Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: Fasting insulin is measured from venous blood samples obtained after 10–12 hours of fasting, using a commercial ELISA kit, and is expressed in µIU/mL. Insulin Resistance. Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is calculated indirectly using the standard formula: fasting blood glucose (mg/dL) × fasting insulin (µIU/mL) / 405, at baseline and at the end of week 6. Glycated Hemoglobin (HbA1c). Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: Immunoturbidimetry. The principle of this method is that a specific antibody binds to HbA1c, forming an immune complex; the turbidity produced is then measured using a biochemistry autoanalyzer. Low-Density Lipoprotein Cholesterol (LDL-C). Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: LDL-C and HDL-C are measured by direct homogeneous enzymatic method from fasting serum using an automated biochemistry analyzer and reported in mg/dL. High-Density Lipoprotein Cholesterol (HDL-C). Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: LDL-C and HDL-C are measured by direct homogeneous enzymatic method from fasting serum using an automated biochemistry analyzer and reported in mg/dL. Nazhvan Darou Dena Co Islamic Azad University, Shahreza Branch (IAU Shahreza) Artesh University of Medical Sciences Nazhvan Darou Dena Co Islamic Azad University, Shahreza Branch (IAU Shahreza) Approved 2026-07-20 Research Ethics Committee of AJA University of Medical Sciences Army University of Medical Sciences, Shahid Etemadzadeh St., West Fatemi St., Tehran Tehran Tehran Iran (Islamic Republic of)