CTRI/2025/02/081350已完成4 期
A Randomized, Double-blind, Placebo-controlled, Parallel Clinical study to assess the effect of TisinaTM complex on Cognitive Health in individuals with Mild Cognitive Impairment
Bridges Consumer Healthcare9 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年4月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 9
- 主要终点
- To assess the effect of Tisina™ complex on Improvement in Cognition Status (attention, memory, fluency, language, Visuospatial) as assessed by Addenbrooke’s Cognitive Examination III (ACE III) as compared to baseline and placebo.
研究概览
简要总结
The present study is a Randomized, Double-blind, Placebo-controlled, Parallel Clinical study. Up to around 112 individuals will be screened and considering a screening failure rate of 25%, approximately 84 will be randomized in a ratio of 1:1 to receive either TisinaTM complex or matching placebo. . Each group will have at least 32 completed participants (total 64 completers) after accounting for a 25% withdrawal/ dropouts rate. The intervention duration for all the study participants is 90 days (intervention phase).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females between
- •75 years old (both values included).
- •Individuals with mild cognitive impairment as indicated by Addenbrooke’s Cognitive Examination (ACE) III score between
- •82 (both values included).
- •Individuals with subjective tinnitus with normal hearing or up to moderate sensorineural hearing loss for more than 6 months’ duration.
- •Tinnitus maskable with noise of at least 5 decibels assessed by audiometry.
- •Individuals with a THI score between 18 to 56 (both values included).
- •Progressive cognitive complaints like stress, disturbed sleep etc. reported by participant or caregiver.
- •Individuals willing to provide a signed and dated informed consent and authorization to use personal health information in accordance with local and national guidance and regulations.
- •Individuals willing to comply with all procedures as outlined in the informed consent.
排除标准
- •Individuals with a medical history of heart disease, respiratory disorders, seizure disorders, metabolic syndrome or other chronic health conditions requiring medication.
- •Clinically diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD)
- •Clinically diagnosed with Alzheimer’s disease.
- •Individuals with clinically significant psychiatric or neurological states, neurodegenerative disorders such as Parkinson’s disease & fronto-temporal dementia, etc, that may account for cognitive impairment.
- •Individuals of objective (pulsatile) tinnitus.
- •Individuals suffering with any congenital anomalies which may lead to any otological problem.
- •Individuals suffering from any infective otological problem.
- •Individuals suffering from any otological problem other than tinnitus and sensorineural hearing.
- •Individuals whose tinnitus resulted from acute acoustic trauma, sudden deafness or traumatic head or neck injury.
- •Individuals taking any ototoxic or potentially tinnitus-inducing medication (e.g., aminoglycosides, chemotherapeutics, loop diuretics, high doses of aspirin or quinine).
- •Individuals with Meniere’s disease, otosclerosis and acute or chronic otitis media.
- •Individuals with history and/or presence significant gastrointestinal disease, active malignant diseases, autoimmune diseases, haemorrhagic diathesis, cardiovascular, renal or hepatic disorders, psychiatric disorders, thyroid disease or any other acute or chronic disease.
- •Individuals who are not willing to maintain their medication, diet or physical activity habits during the study.
- •Individuals with uncontrolled Hypertension with systolic blood pressure more than or equal to 140 and/or diastolic blood pressure more than or equal to 90 mm Hg.
- •Individuals with FBG more than or equal to 126 mg/dl.
- •Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) values exceeding 2 times the upper normal limit.
- •Serum creatinine levels exceeding 1.5 times the upper normal limit.
- •Head injury immediately preceding cognitive deterioration.
- •Use of psychotropic drugs or any other drug or supplement such as nootropics that may significantly affect cognitive functioning during the month prior to psychometric testing.
- •Use of any experimental medication or OTC medication or herbal treatment such as hesperidin, diosmin and other flavonoids within 1 month prior to screening.
- •Females taking any oral contraceptives.
- •Current smokers.
- •Consumption of excessive amount of caffeine i.e.more than or equal to 4 cups daily (more than 500 mg per day).
- •History of drug, substance or alcohol addiction or abuse within the past 12 months.
- •Prior participation in a clinical study in the past 90 days before screening.
- •Females who are pregnant/planning to be pregnant or currently lactating.
结局指标
主要结局
To assess the effect of Tisina™ complex on Improvement in Cognition Status (attention, memory, fluency, language, Visuospatial) as assessed by Addenbrooke’s Cognitive Examination III (ACE III) as compared to baseline and placebo.
时间窗: Day 0, Day 20, Day 45 and Day 90
次要结局
- To assess the effect of Tisina™ complex in comparison to baseline and placebo on loudness, distress, and Quality of life (QoL) in Tinnitus as assessed by Tinnitus Visual Analog Scale (T-VAS)(Day 0, Day 20, Day 45 and Day 90)
- To assess the effect of Tisina™ complex in comparison to baseline and placebo on severity of tinnitus for Tinnitus loudness, Tinnitus frequency pitch, and Minimum masking level (MML) by Audiometric tests.(Day 0, Day 20, Day 45 and Day 90)
- To assess the effect of Tisina™ complex in comparison to baseline and placebo on change in Subjective discomfort due to Tinnitus as assessed by Tinnitus Handicap inventory (THI).(Day 0, Day 20, Day 45 and Day 90)
- To assess the effect of Tisina™ complex in comparison to baseline and placebo on stress as assessed by the Perceived Stress Scale (PSS).(Day 0, Day 20, Day 45 and Day 90)
- To assess the effect of Tisina™ complex in comparison to baseline and placebo on quality of life as assessed by Neuro-QOL questionnaire for Sleep and cognition function.(Day 0, Day 20, Day 45 and Day 90)
研究者
Dr Sanjay Vaze
Vedic Lifesciences Pvt Ltd
研究点 (9)
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