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IRCT20251018067673N2 IRCT 2026-11-04 Hakim Sabzevari University Efficacy of Frankincense Extract on Mild Cognitive Impairment and Evaluation of Brain-Derived Neurotrophic Factor Efficacy of Frankincense Extract on Mild Cognitive Impairment and Evaluation of Brain-Derived Neurotrophic Factor (BDNF) as a Biomarker for Diagnosis and Monitoring of Treatment Response: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial" 2026-10-23 anticipated 60 Recruiting https://irct.ir/trial/88095 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated to two groups—intervention (frankincense extract) and control (placebo)—in a 1:1 ratio using randomized block randomization with a block size of 4. In each 4-patient block, two patients will be assigned to the intervention group and two to the control group, and the order of assignments within each block will be generated randomly by statistical software to ensure that the allocation sequence is unpredictable, Blinding description: The intervention consisted of capsules containing Boswellia extract and placebo, which were identical in shape, color, size, odor, and packaging. The capsules were coded by a pharmacist or an independent investigator, and the group allocation code was kept in a sealed envelope by a third party. Randomization of participants to groups was performed using a randomization method, and the codes were not opened until the statistical analysis was completed. Cognitive assessments (MoCA/MMSE) and measurement of serum BDNF levels were performed by evaluators and the laboratory, who were unaware of the group allocation of participants. Data analysis was also performed based on anonymous codes. 1-2 Mild cognitive impairment. Intervention 1: The intervention group will receive a standardized extract of frankincense (*Boswellia* spp.)—produced by the company Giah Kala—orally at a daily dose of 5 mL, once a day for 8 weeks, in addition to their usual standard care. Data collection, involving the completion of questionnaires and the collection of blood samples, will take place at two time points: at the beginning of the study and after 8 weeks. Intervention 2: The control group receives a placebo (lactulose)—identical in appearance, color, odor, and packaging—at a dose of 5 mL once daily for 8 weeks, alongside standard routine care. Data collection, involving the completion of questionnaires and blood sampling, is conducted at two time points: at the beginning of the study and after 8 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 I haven't decided yet because I need to get this permission from the university.
public Reyhane Sabbaghzade
Bolvar Shohadae ghomnam
Sabzevar Iran (Islamic Republic of) ۹۶۱۷۹۷۶۴۸۷ +98 51 4401 2607 r.sabbaghzadeh@hsu.ac.ir Hakim Sabzevari university scientific Reihaneh Sabbaghzadeh
Thaleghani
Sabevar Iran (Islamic Republic of) ۹۶۱۷۹۷۶۴۸۷ +98 51 4401 2998 r.sabbaghzadeh@hsu.ac.ir Hakim sabzevari university Iran (Islamic Republic of) Individuals aged 50 to 75 mild cognitive impairment (MCI) based on Petersen or DSM-5-TR criteria with consistent scores on MoCA/MMSE tests, capable of cooperation informed consent 50 years 75 years Both Definitive diagnosis of dementia severe depression active systemic underlying diseases hypersensitivity to frankincense G31.84 Mild cognitive impairment, so stated Treatment - Drugs Treatment - Drugs The intervention group will receive a standardized extract of frankincense (*Boswellia* spp.)—produced by the company Giah Kala—orally at a daily dose of 5 mL, once a day for 8 weeks, in addition to their usual standard care. Data collection, involving the completion of questionnaires and the collection of blood samples, will take place at two time points: at the beginning of the study and after 8 weeks. The control group receives a placebo (lactulose)—identical in appearance, color, odor, and packaging—at a dose of 5 mL once daily for 8 weeks, alongside standard routine care. Data collection, involving the completion of questionnaires and blood sampling, is conducted at two time points: at the beginning of the study and after 8 weeks. Primary Outcome:Change in serum brain-derived neurotrophic factor (BDNF) levels from baseline to the end of the intervention period in patients with mild cognitive impairment. Timepoint: Study outcomes will be assessed at two time points:Baseline: prior to initiation of the intervention and after completion of the treatment period. Method of measurement: Serum brain-derived neurotrophic factor (BDNF) levels will be measured using blood samples by the enzyme-linked immunosorbent assay (ELISA) method with a validated commercial kit, according to the manufacturer’s instructions. Change in cognitive function in patients with mild cognitive impairment, assessed by changes in MoCA and MMSE scores from baseline to the end of the intervention period. Timepoint: 1-Baseline, before initiation of the intervention2-End of the intervention period (e.g., after 8 or 12 weeks). Method of measurement: Cognitive function will be measured using the standard Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) tests, administered by a trained assessor under standardized conditions. Hakim Sabzevari University Approved 2025-11-19 Ethics Committee of Hakim Sabzevari University Tohidshahr- Hakim Sabzevari University Sabzevar Razavi Khorasan Iran (Islamic Republic of)