]>
IRCT20180710040406N1 IRCT 2018-12-02 Niak company The effect of Padzahr tablet on Osteopenia Assessment of the effect of Padzahr tablet on the turnover of bone formation in postmenopausal osteopenic women: A Randomized Double-Blind Placebo-Controlled Trial 2018-11-21 anticipated 44 Complete https://irct.ir/trial/34096 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be selected based on inclusion and exclusion criteria and divided into 2 groups, randomized, in the order of admission. Every group, based on the age, will be divided into 4 subgroups, 40-55, 50-55, 55-60 and 60-65. The first one of the same age groups, will receive drug A and drug B will be given the second one and the others, by turns, will receive drug A or drug B, Blinding description: Drug and placebo will have codes and participants, Principal researcher, medical personnel, data collection authorities and statistical analyzer will not have information about drug and placebo groups. 3 Osteopenia. Intervention 1: Intervention group: Osteopenic postmenopausal women, will be ordered Padzahr tablet: 6 tablets daily, divided in 3 doses. Intervention 2: Control group: Osteopenic postmenopausal women, will be ordered placebo tablet: 6 tablets daily, divided in 3 doses. 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 Consultation with other members of research team
public Shabnam Rafiee
No. 27, Northen Sarparast street, West Taleghani Ave., Felestin square
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8897 4535 Shara_514@yahoo.com Tehran University of Medical Sciences scientific Shabnam Rafiee
No. 27, Northen Sarparast street, West Taleghani Ave., Felestin square
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8897 4535 Shara_514@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Osteopenic postmenopausal women Greater than 45 and under 65 years of age Osteopenia, based on WHO definition: T Score between -2.5 and -1 No history of allergy and anaphylaxis 45 years 65 years Female Use of Tobacco products, Alcohol and narcotic products History of choronic diseases, including Cancer, Cardiovascular diseases, Diabetes mellitus, Renal failure, Liver diseases, Systemic inflammatory diseases, Degenerative joint diseases, Rheumatologic disorders, Thalassemia, Primary hyperparathyroidism, Hyperthyroidism, Cushing's syndrome, Hypercalciuria, Hypogonadism Gastrointestinal diseases, including Crohn's disease, Ulcerative colitis, Celiac, Choronic diarrhea, under treatment gastric or duodenal ulcer, history of gastrointestinal bleeding History of drug consumption, affecting bone metabolism like Osteoporosis drugs , Diuretics, Thiazides, Anti convulsive drugs, Glucocorticoides and NSAIDES Motor disability and skeletal disorders except Osteopenia Untreated psychologic or neurologic diseases like Psychosis, Alzheimer and Parkinson Diseases History of bone diseases No tendency for randomization M81.0 Age-related osteoporosis without current pathological fracture Treatment - Drugs Placebo Intervention group: Osteopenic postmenopausal women, will be ordered Padzahr tablet: 6 tablets daily, divided in 3 doses. Control group: Osteopenic postmenopausal women, will be ordered placebo tablet: 6 tablets daily, divided in 3 doses. Turnover of bone formation based on Laboratory tests. Timepoint: Baseline and after 3 months. Method of measurement: ELISA laboratory tests. Plasma Osteocalcin (OC). Timepoint: At the beginning of the study and 3 months after start of drug using. Method of measurement: Elisa Test. Plasma Bone Alkaline Phosphatase (BAP). Timepoint: At the beginning of the study and 3 months after start of drug using. Method of measurement: Elisa Test. Plasma Procollagen Type 1 N-Terminal Propeptide (P1NP). Timepoint: At the beginning of the study and 3 months after start of drug using. Method of measurement: Elisa Test. Plasma C-terminal telopeptide (carboxy-terminal collagen crosslinks) (CTX). Timepoint: At the beginning of the study and 3 months after start of drug using. Method of measurement: Elisa Test. Niak company Approved 2018-09-13 Ethics committee of Tehran University of Medical Sciences No. 27, Northen Sarparast street, West Taleghani Ave., Felestin square Tehran Tehran Iran (Islamic Republic of)