The Effect of Elaeagnus angustifolia as a Drug-Food on Osteoporosis: A Triple-Blind Randomized Clinical Trial

Determining the Effect of Elaeagnus angustifolia on Osteoporosis

A controlled clinical trial with parallel groups, triple-blind, randomized, conducted on 3 groups of 50 patients each. Randomization is performed using the sealedenvelope website.

Patients diagnosed with osteoporosis who visit Shariati Hospital in Tehran during the study will be enrolled in the study if eligible, and will be randomly assigned to intervention and control groups using the block randomization method. This study is conducted in a triple-blind manner, such that the patients, the physician, and the data analyst will not be aware of the type of intervention.

Inclusion Criteria: osteoporosis Patients aged 50 to 70 years of both sexes; Exclusion Criteria: Smoking, alcohol, and substance abuse; Chronic diseases such as cancer, renal failure, autoimmune diseases; Family history of estrogen-related cancers; Malabsorption syndrome caused by gastrointestinal diseases; Use of medications affecting bone metabolism within the past three months; Pregnancy and breastfeeding; bone fracture

Intervention group 1: oleaster powder with seeds, Intervention group 2: oleaster powder without seeds, Control group (placebo): roasted wheat flour, Group 1 receives 20 g of oleaster fruit powder with seeds and 10 g of milk powder every day, group 2 receives 20 g of oleaster powder without seeds and 10 g of milk powder every day, and group 3 receives 20 g of placebo powder (roasted wheat flour) and 10 g of milk powder daily. This regimen will continue for 3 months, to be consumed as an afternoon snack. Drugs are produced in the laboratory of the School of Persian Medicine, Tehran University of Medical Sciences.

Bone formation; bone resorption

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.

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.

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

Access to the data is available on a case-by-case basis, upon written request submitted via email.

Domestic researchers whose research project has been registered in the Nopa (NOPA) system may access the data.

The data are available for the design of systematic reviews, meta-analyses, or other domestic studies.

To obtain the data, an email should be sent to the principal investigator.

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.

For foreign researchers, the information will be provided upon approval by the Vice-Dean for Research of the faculty.