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IRCT20260104068538N1 IRCT 2026-09-06 Bojnourd University of Medical Sciences Investigating the effect of Berberis integerrima Bunge extract on blood sugar control in patients with diabetes type 2 Investigating the effect of Berberis integerrima Bunge extract on blood sugar control in patients with diabetes type2: A clinical trial 2026-09-06 anticipated 50 Recruiting https://irct.ir/trial/88744 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study will be performed at the individual level using block randomization with a 1:1 allocation ratio. To maintain balance between the intervention and control groups, variable block sizes of 4 and 6 will be used. The random allocation sequence will be generated before participant enrollment using computer-generated random numbers by an independent person who is not involved in participant recruitment, assessment, or follow-up. After confirming each participant’s eligibility and obtaining informed consent, a unique study code will be assigned according to the order of enrollment. Group allocation will then be performed according to the pre-generated random sequence. For allocation concealment, group assignments will be placed in sequentially numbered, opaque, light-impermeable, sealed envelopes. The envelopes will be opened in numerical order only after the participant has been formally enrolled and baseline information has been recorded. The person responsible for generating the random sequence and preparing the allocation codes will have no role in participant recruitment, outcome assessment, or data analysis. As the study is double-blind, the mountain barberry extract and placebo will be made similar in appearance, capsule form, packaging, and administration schedule, and will be identified only by study codes. Therefore, both participants and outcome assessors will remain unaware of the assigned intervention, Blinding description: This study is designed as a randomized double-blind clinical trial. After obtaining written informed consent and confirming eligibility, participants will be randomly allocated into either the intervention group or the control group using a random number table. Participants in the intervention group will receive the investigational drug, while those in the control group will receive the standard routine treatment according to the approved therapeutic protocol. To ensure proper blinding, the investigational drug and the routine medication will be matched in appearance, color, size, packaging, and administration schedule, and will be provided in coded containers. 0 (exploratory trials) Type 2 diabetes. Intervention 1: Intervention group: Participants will receive 1500 mg/day of standardized Berberis integerrima Bunge fruit extract orally for eight weeks. The daily dose will be administered in two divided doses of 750 mg each. The berberine content of the extract will be determined and documented after standardization of the study product. The capsules will be prepared and packaged by [manufacturer/production center]. Participants will continue their usual antidiabetic treatment during the study, and any clinically necessary treatment changes will be documented. Intervention 2: Control group: The control group receives an identical placebo; the placebos are standardized in appearance and packaging to maintain complete blinding. Yes - There is a plan to make this available What will be shared: Presentation of research project documentation investigating the effect of consuming mountain barberry extract (a plant from the Berberis integerrima Bunge family) on blood sugar control in patients with type 2 diabetes: a clinical trial regarding the study process and participation of individuals in the study, along with submitting the results. When: Documentation will be uploaded within 1 to 4 months after the article is completed. To whom: Researcher, Supervisor, Analyst Conditions: The use of the data is solely for the purpose of printing and publishing this article. Use in other cases must be possible only with the coordination of the organizer. Where to obtain: project manager How to obtain: Send request by email ramezani80amirhosein@yahoo.com Comments:
public Amirhosein Ramezani
Vice Chancellor for Research and Technology, North Khorasan University of Medical Sciences, Shahriar St
Bojnourd Iran (Islamic Republic of) 9413884648 +98 58 3151 0000 ramezani80amirhosein@yahoo.com Bojnourd University of Medical Sciences scientific Dr.Amir Amani
North Khorasan University of Medical Sciences, Dowlat Blvd., Bojnord,
Bojnord Iran (Islamic Republic of) 9414974877 +98 58 3151 0000 info@nkums.ac.ir Bojnourd University of Medical Sciences Iran (Islamic Republic of) Age between 30 and 65 years Diagnosis of type 2 diabetes mellitus by a physician HbA1c between 7% and 10% at enrollment Stable type and dose of antidiabetic medications for at least three months before enrollment Willingness to participate in the study and provide written informed consent Ability to regularly use the study product during the eight-week intervention period 30 years 75 years Both Severe renal impairment Severe liver disease Unstable cardiovascular disease Pregnancy or breastfeeding Concurrent use of herbal supplements or products with glucose-lowering effects Known allergy to barberry or barberry-containing products Presence of a disease or condition that interferes with the measurement or interpretation of HbA1c E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: Participants will receive 1500 mg/day of standardized Berberis integerrima Bunge fruit extract orally for eight weeks. The daily dose will be administered in two divided doses of 750 mg each. The berberine content of the extract will be determined and documented after standardization of the study product. The capsules will be prepared and packaged by [manufacturer/production center]. Participants will continue their usual antidiabetic treatment during the study, and any clinically necessary treatment changes will be documented. Control group: The control group receives an identical placebo; the placebos are standardized in appearance and packaging to maintain complete blinding. Blood sugar control in patients with type 2 diabetes. Timepoint: Fasting blood glucose will be measured at baseline, before the intervention, and at the end of the eighth week after initiation of the intervention. Method of measurement: Blood sugar will be measured in the laboratory of Imam Reza Hospital (AS) and will be checked after an 8-hour fast. Blood sugar control in patients with type 2 diabetes. Timepoint: Glycated hemoglobin will be measured at baseline, before the intervention, and at the end of the eighth week after initiation of the intervention. Method of measurement: Blood sugar will be measured in the laboratory of Imam Reza Hospital (AS) and will be checked after an 8-hour fast. HbA1c. Timepoint: The beginning and end of the study. Method of measurement: Laboratory test. FBS. Timepoint: The beginning and end of the study. Method of measurement: Laboratory test. Consumption of barberry. Timepoint: daily. Method of measurement: Counting of pills taken by the presenter as well as the individual's self-declaration. Bojnourd University of Medical Sciences Approved 2025-09-14 Ethics committee of North Khorasan University of Medical Sciences Vice Chancellor for Research and Technology, North Khorasan University of Medical Sciences, Shahriar St. Bojnord North Khorasan Iran (Islamic Republic of)