Investigating the effect of Berberis integerrima Bunge extract on blood sugar control in patients with diabetes type2: A clinical trial

Determining the effectiveness of consuming mountain barberry extract on blood sugar control in patients with type 2 diabetes

This study is designed as a randomized, double-blind, placebo-controlled clinical trial. The sample size is 50 people. Randomization in this study will be performed at the individual level using a block randomization method with an allocation ratio of 1:1.

This trial will be conducted at the specialized clinic of Imam Reza Hospital in Bojnord on 50 patients with type 2 diabetes. Participants will be randomly allocated to intervention and control groups and will receive mountain barberry extract or a matching placebo for 8 weeks. Fasting blood glucose and glycated hemoglobin will be measured at baseline and at the end of week 8. The study will be double-blind; participants and outcome assessors will be unaware of group allocation, and the study products will be provided in identical, coded packaging.

Inclusion criteria:** Age 30–75 years; confirmed diagnosis of type 2 diabetes; HbA1c between 6.5% and 9%; stable antidiabetic treatment for at least 3 months; willingness to participate in the study. Exclusion criteria:** Severe renal failure; significant liver dysfunction; unstable cardiovascular disease; pregnancy or lactation; concomitant use of antidiabetic herbal supplements; known allergy to barberry; significant changes in blood glucose during the study; occurrence of serious adverse events; withdrawal of consent or failure to continue participation.

The intervention group will receive 1500 mg/day of standardized mountain barberry extract in two divided doses for 8 weeks. The control group will receive a matching placebo for the same period.

Fasting blood glucose; glycated hemoglobin.

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.

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.

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.

Documentation will be uploaded within 1 to 4 months after the article is completed.

Researcher, Supervisor, Analyst

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.

project manager

Send request by email ramezani80amirhosein@yahoo.com