A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Study to Assess the Effect of Tisina Complex on Cognitive Health in Individuals With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 16
- 主要终点
- To asses 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, placebo-controlled, double-blind, parallel-group clinical study designed to assess the effects of IP in individuals with mild cognitive impairment and Tinnitus as compared to a placebo. Approximately 112 individuals aged between 30 and 75years will be screened. Considering a screen failure of 25%, approximately 84 individuals will be randomized in a ratio of 1:1 to receive either the active or placebo. The study will have at least 64 completed participants i.e. 32 participants in each study arm after accounting for adropout/withdrawal rate of 25% at the end of the study. The intervention and follow up duration for all the study participants will be 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 30 - 75 years old (both values included).
- •Individuals with mild cognitive impairment as indicated by Addenbrooke's Cognitive Examination (ACE) III score between 61 - 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.
- •History of uncontrolled migraine headaches, severe sleep disorders.
- •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. ≥ 4 cups daily (> 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.
研究组 & 干预措施
Arm 1: TisinaTM complex
Route of administration: Oral. Dose: 500 mg (2 caplets) at a single time. Regimen: Take 2 caplets, three times a day (total of 6 caplets daily) with meals.
干预措施: Arm 1: TisinaTM complex (Dietary Supplement)
Arm 2: Placebo (Microcrystalline Cellulose)
Route of administration: Oral. Dose: 500 mg (2 caplets) at a single time. Regimen: Take 2 caplets, three times a day (total of 6 caplets daily) with meals.
干预措施: Arm 2: Placebo (Microcrystalline Cellulose) (Dietary Supplement)
结局指标
主要结局
To asses 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]
On Day 0, participants will receive study instructions. Cognitive status will be assessed on Days 20, 45, and 90 to evaluate symptom improvement and the efficacy of the investigational product (IP) compared to baseline and placebo.
次要结局
- To asses the effect of Tisina complex in comparison to baseline and placebo on Loudness, distress, and QOL in Tinnitus as assessed by Tinnitus Visual Analog Scale (TVAS).(Day 0, Day 20, Day 45 and Day 90)
- To asses 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 asses 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 asses 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 asses the effect of Tisina complex in comparison to baseline and placebo on Quality of life as assessed by "Quality of Life in Neurological Disorders" questionnaire for Sleep and cognition function.(Day 0, Day 20, Day 45 and Day 90)