Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612762
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
Naringenin Supplementation in Bone Fracture Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Naringenin Supplementation on the Speed of Bone Fusion and the Concentration of Plasma Inflammatory Factors in Patients with Bone Fractures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fractures of the lower extremities represent a significant proportion of injuries sustained by polytrauma patients with a notable association with prolonged hospitalization chronic disability and impaired physical functioning The occurrence of surgical site infections SSI represents a significant threat to the efficacy of osteosynthesis procedures As with other traumas and surgical procedures the secretion of inflammatory mediators is markedly elevated in this cohort of patients following surgery Naringenin is one of the most prevalent flavonoids occurring naturally in grapefruit and other citrus fruits In vitro studies have demonstrated that naringenin may stimulate the release of osteogenic cytokines and suppress the production of pro-inflammatory factors which can result in a reduction in bone resorption Based on these findings naringenin may prove an effective agent for accelerating the rate of fusion and controlling inflammation Furthermore it may enhance quality of life and augment functional activity
Detailed Description:
The study subjects will be selected from among the patients with bone fractures of the lower limbs who are hospitalized in the orthopedic department of Ayatollah Taleghani University Hospital in Tehran The following criteria will be used to determine which patients are eligible for inclusion in the study
Inclusion criteria patients aged 18 to 60 years candidates for orthopedic surgery for bone fractures of the lower limbs ambulatory without assistance for a minimum of two months prior to the fracture not having undergone amputation of the lower limbs not suffering from liver cirrhosis not suffering from advanced kidney failure blood creatinine higher than 14 mgdL not having metastatic cancer Additionally subjects must not have any chronic inflammatory diseases nor must they be taking any drugs that affect bone metabolism including calcitonin bisphosphonates and corticosteroids Furthermore subjects must not be taking any anti-inflammatory drugs
Subjects will be excluded from the study if they experience an allergic or intolerant reaction to Narangenin capsules if there are any abnormal changes in their liver kidneys tests or if they fail to consume more than 10 of their capsules in weekly monitoring
Subjects will be randomly assigned to one of two intervention groups Narangenin capsules or a control group receiving a placebo Patient assignment will be conducted using the stratified permuted block randomization method Patients will be randomly assigned to one of two intervention groups narangenin capsules or a control group placebo based on their history of diabetes Each stratum will consist of four cases with two cases assigned to the placebo group and two cases assigned to the naringenin group To ensure the blinding of the study the capsules will be identical in appearance and packaged in the same containers Each capsule of the intervention group will contain 250 mg of naringenin while each capsule of the control group will contain 250 mg of starch The capsules are administered to the patients by the nursing staff who are unaware of the patient grouping The supplementation regimen will commence one day following surgery with participating patients receiving two capsules equivalent to 500 mg daily for 14 days Subsequently following a 14-day period the patients will resume the maintenance dose of 250 mg per day until the 90th day post-surgery During the intervention period patients will be monitored for regular use of the capsules and any adverse reactions Patients will be required to attend the hospitalampamp39s orthopedic clinic on two occasions 14 days after surgery and three months after surgery During these visits fasting blood samples will be taken for biochemical tests The fusion status of patients will be evaluated by radiography after surgery 14 days and three months after surgery Additionally functional testing Oswestry disability index ODI will be performed two weeks and three months after surgery
Inclusion criteria patients aged 18 to 60 years candidates for orthopedic surgery for bone fractures of the lower limbs ambulatory without assistance for a minimum of two months prior to the fracture not having undergone amputation of the lower limbs not suffering from liver cirrhosis not suffering from advanced kidney failure blood creatinine higher than 14 mgdL not having metastatic cancer Additionally subjects must not have any chronic inflammatory diseases nor must they be taking any drugs that affect bone metabolism including calcitonin bisphosphonates and corticosteroids Furthermore subjects must not be taking any anti-inflammatory drugs
Subjects will be excluded from the study if they experience an allergic or intolerant reaction to Narangenin capsules if there are any abnormal changes in their liver kidneys tests or if they fail to consume more than 10 of their capsules in weekly monitoring
Subjects will be randomly assigned to one of two intervention groups Narangenin capsules or a control group receiving a placebo Patient assignment will be conducted using the stratified permuted block randomization method Patients will be randomly assigned to one of two intervention groups narangenin capsules or a control group placebo based on their history of diabetes Each stratum will consist of four cases with two cases assigned to the placebo group and two cases assigned to the naringenin group To ensure the blinding of the study the capsules will be identical in appearance and packaged in the same containers Each capsule of the intervention group will contain 250 mg of naringenin while each capsule of the control group will contain 250 mg of starch The capsules are administered to the patients by the nursing staff who are unaware of the patient grouping The supplementation regimen will commence one day following surgery with participating patients receiving two capsules equivalent to 500 mg daily for 14 days Subsequently following a 14-day period the patients will resume the maintenance dose of 250 mg per day until the 90th day post-surgery During the intervention period patients will be monitored for regular use of the capsules and any adverse reactions Patients will be required to attend the hospitalampamp39s orthopedic clinic on two occasions 14 days after surgery and three months after surgery During these visits fasting blood samples will be taken for biochemical tests The fusion status of patients will be evaluated by radiography after surgery 14 days and three months after surgery Additionally functional testing Oswestry disability index ODI will be performed two weeks and three months after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None