NCT04436614

Management of Mild Cognitive Impairment Patients With Aloe and Crocus - BALSAM

Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of Aloe Vera and Crocus in Patiens With Mild Cognitive Impairment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

There is accumulating evidence suggesting that Aloe vera and Crocus (saffron) may have a positive impact on conditions involving cognitive deficits, such as Mild Cognitive Impairment (MCI) and AD. More specifically, aloe vera gel contains powerful antioxidants, which belong to a large family of substances known as polyphenols. Aloe has also been proven to possess cholinergic and cognitive enhancing capabilities. Crocus is deeper studied and it shows promising results in neuroprotection against AD through various suggested mechanisms, such as the enhancement of amyloid-beta clearance in the brain and the inhibition of neurofibrillary tangles formation. For this reason, it would be interesting to study the effects of combination of Aloe Vera and Crocus . The aim of the study is to evaluate the beneficial effect of Aloe Vera and Crocus (saffron) in comparison with Aloe (simple)on patients diagnosed with mild cognitive impairment MCI. Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention

Detailed description

OBJECTIVES OF THE TRIAL The objectives of this study are: To investigate the efficacy of Aloe Vera and Crocus as a disease course modifying treatment for MCI in a phase III double-blind placebo-controlled study. To investigate the effects in objective measurements in patients with MCI. STUDY DESIGN This is a Greek, randomised, double-blind, placebo-controlled study group of compared Aloe Vera and Crocus with placebo. Qualifying patients will be randomly assigned to receive 45 mL of Aloe Vera and Crocus or placebo (ALOE) or mediterranean dietary protocol on a daily basis for 24 months. Patients undergo assessments at baseline,12 and 24 months +/- 7 days after beginning of the treatment. Duration The total study duration will be 36 months. Patients will receive study medication for 24 months.The recruitment will be about 6 months and the statistics and the preparation of the paper other 6 months. Number of Subjects One hundred fifty (150) subjects total will be enrolled. ; Fifty (50) in the experimental group (Aloe Vera with Crocus); Fifty (50) in the Control Group 1(Aloe) and fifty (50) in control Group 2(same dietary habits-mediterranean dietary protocol). Patient Eligibility Screening Form (ESF) An eligibility form documenting the patient's fulfilment of the entry criteria will be completed by the assessor. The following information will be included in the ESF: Patient identification: Initials (First initial of first name and First initial of surname), date of birth and Patient Identification Number. Eligibility Screening; Checklist of inclusion and exclusion criteria Eligibility Statement; for patients found to be ineligible, the reason for ineligibility must be stated Written informed consent will be obtained from the subject . The informed consent form must be co-signed by the physician. The nature of the study and the potential risks associated with the trial will be explained to all subject candidates and their responsible informants. Signature and date: the ESF may be completed by an assessor but it is required that the principal investigator/study clinician sign and date the ESF to verify eligibility of the patient for inclusion.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Supplement:Aloe Vera with Crocus (saffron)	Dietary Supplement:Aloe Vera with Crocus (saffron) with 1L of Aloe Vera with Crocus (saffron) 1 glass bottle per 15 days
DIETARY_SUPPLEMENT	Dietary Supplement:Aloe Vera (simple)	Dietary Supplement:Aloe Vera (simple)with 1L of Aloe Vera 1 glass bottle per 15 days
DIETARY_SUPPLEMENT	Dietary Supplement:Mediterranean Diet	Dietary Supplement:Mediterranean dietary protocol Intervention:mediterranean diet

Timeline

• Start date: 2017-12-17
• Primary completion: 2018-05-30
• Completion: 2019-10-30
• First posted: 2020-06-18
• Last updated: 2020-06-22

Locations

1 site across 1 country: Greece