A Randomized Placebo controlled clinical trial to evaluate efficacy of OLS-01 (Oil liquid filled capsules supplement) on cognitive performance in adult patients with mild disturbance of cognitive/memory memory function secondary to Parkinsons disease or stroke

Olive Life Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•A) Participant is willing and able to give informed consent for participation in the trial, especially with diagnosed of stroke induced cognitive malfunction and ParkinsonÃ¢â?¬•s disease induced cognitive malfunction.
•B) Male or Female, aged 18 years or above.
•C) Diagnosed with required disease/severity/symptoms, any specific assessment criteria for these, or, if healthy volunteer trial: be in good health.
•D) Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter.
•E) Participant has clinically acceptable laboratory and ECG results (specify any other additional assessments) within of enrolment.
•F) In the InvestigatorÃ¢â?¬•s opinion, is able and willing to comply with all trial requirements.
•G) Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.

•A) Female participant who is pregnant, lactating or planning pregnancy during the trial.
•B) Significant renal or hepatic impairment.
•C) Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
•D) Participant with life expectancy of less than 6 months or is inappropriate for placebo medication.
•E) Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participantÃ¢â?¬•s ability to participate in the trial.
•F) Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
•G) Diagnosis of intellectual disability, dementia, or neurological disorder including but not limited to cerebral vascular disease; previous head injury, or coronary artery bypass or neurosurgical procedure; history of smoking, alcohol or drug abuse; metabolic disease including diabetes; untreated asthma; shift workers.

发起方

Olive Life Sciences Pvt Ltd