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IRCT20260715070198N1 IRCT 2026-09-18 Tehran University of Medical Sciences Effect of Oleaster in Osteoporosis The Effect of Elaeagnus angustifolia as a Drug-Food on Osteoporosis: A Triple-Blind Randomized Clinical Trial 2026-09-23 anticipated 150 Recruiting https://irct.ir/trial/91748 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Oleaster (Russian olive) is considered a nutraceutical (medicinal food), Randomization description: Patients will be divided into three groups using permuted block randomization. We will use the website https://www.sealedenvelope.com to generate the random sequence for the block randomization approach. In this process, the blocks will be of size three. Opaque sealed envelopes will be used for allocation concealment. Cards indicating the type of intervention, labeled with the letters A, B, and C, will be prepared. These cards will then be placed inside opaque envelopes, which will be sealed. Each envelope will be assigned a number according to the generated random sequence, marked on the envelope, and given to the physician. Patients will receive a numbered envelope in the order they present to the physician and will then be referred to the secretary to receive the corresponding medication. For each national ID code, the medication code will be recorded by the secretary. The patient list will be provided to the researcher at the end of the study, once the sample size has been completed, Blinding description: The patient, physician, assistant, secretary, and the data analyst will all be blinded to the type of treatment received by the patients. The medications will be prepared in the form of identical sachets across the three groups, and only the person who prepared the medications will be aware of the content of each group of sachets. 3 osteoporosis. Intervention 1: Intervention group 1 (oleaster powder with seeds): Intervention group 1 dissolved one sachet containing 20 g of oleaster fruit powder with seeds and 10 g of milk powder in water daily for three months and consumed it as a snack. The drug is produced in the laboratory of the School of Persian Medicine, Tehran University of Medical Sciences. Intervention 2: Intervention group 2 (oleaster powder without seeds): Intervention group 2 dissolved one sachet containing 20 g of oleaster fruit powder without seeds and 10 g of milk powder in water daily for three months and consumed it as a snack. The drug is produced in the laboratory of the School of Persian Medicine, Tehran University of Medical Sciences. Intervention 3: Control group: The control (placebo) group dissolved one sachet containing 20 g of roasted wheat flour powder and 10 g of milk powder in water daily for three months and consumed it as a snack. The drug is produced in the laboratory of the School of Persian Medicine, Tehran University of Medical Sciences. Yes - There is a plan to make this available What will be shared: The anonymized data file (without patient identifying information) is held by the principal investigator. This file will be made available to researchers upon written request and approval by the principal investigator When: Access to the data is available on a case-by-case basis, upon written request submitted via email. To whom: Domestic researchers whose research project has been registered in the Nopa (NOPA) system may access the data. Conditions: The data are available for the design of systematic reviews, meta-analyses, or other domestic studies. Where to obtain: To obtain the data, an email should be sent to the principal investigator. How to obtain: Ten days after receipt of the email, following verification of the ethics code or the project's registration in the Nopa system, the information will be provided. Comments: For foreign researchers, the information will be provided upon approval by the Vice-Dean for Research of the faculty.
public Dr Fatemeh Nejatbakhsh
No. 27, North Sarparast Street, West Taleghani Street, Palestine Square, Tehran
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 4535 nejatbakhsh@tums.ac.ir Tehran University of Medical Sciences scientific Dr Fatemeh Nejatbakhsh
No. 27, North Sarparast Street, West Taleghani Street, Palestine Square, Tehran
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 4535 nejatbakhsh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) osteoporosis Patients aged 50 to 70 years of both sexes 50 years 70 years Both Smoking, alcohol, and substance abuse Chronic diseases such as cancer, renal failure, autoimmune diseases Malabsorption syndrome caused by gastrointestinal diseases Use of medications affecting bone metabolism within the past three months Family history of estrogen-related cancers Pregnancy and breastfeeding bone fracture M81 Osteoporosis without current pathological fracture Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1 (oleaster powder with seeds): Intervention group 1 dissolved one sachet containing 20 g of oleaster fruit powder with seeds and 10 g of milk powder in water daily for three months and consumed it as a snack. The drug is produced in the laboratory of the School of Persian Medicine, Tehran University of Medical Sciences Intervention group 2 (oleaster powder without seeds): Intervention group 2 dissolved one sachet containing 20 g of oleaster fruit powder without seeds and 10 g of milk powder in water daily for three months and consumed it as a snack. The drug is produced in the laboratory of the School of Persian Medicine, Tehran University of Medical Sciences Control group: The control (placebo) group dissolved one sachet containing 20 g of roasted wheat flour powder and 10 g of milk powder in water daily for three months and consumed it as a snack. The drug is produced in the laboratory of the School of Persian Medicine, Tehran University of Medical Sciences Bone resorption. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: C-terminal telopeptide (CTX) measurement by electro chemiluminescence immunoassay in a fasting morning blood sample. Bone formation. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: N-terminal propeptide (P1NP) measurement by electro chemiluminescence immunoassay in a fasting morning blood sample. Quality of life. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: Quality of Life Questionnaire of the European Foundation for Osteoporosis (ECOS-16). Bone and joint pain. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: Visual Analogue Scale. Tehran University of Medical Sciences Approved 2026-06-05 Research Ethics Committee of The institute of Pharmaceutical Sciences - TUMS Faculty of Medicine, Tehran University of Medical Sciences, 16 Azar Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)