A Randomized Double-blind Placebo-Controlled Trial To Evaluate Efficacy And Safety Of Suprabrain®, A Polyherbal Formulation On Cognitive Function
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
研究概览
简要总结
Suprabrain® consists of clinically established constituents known for their neuroprotective and anti-inflammatory properties, with traditional use in improving memory, dementia, and Alzheimer’s disease symptoms. Its components are drawn from herbal agents with a rich history in cognitive support.
Ashwagandha (Withania somnifera) is a small woody shrub traditionally used for over 3000 years in Ayurvedic medicine as a Rasayana, or rejuvenator, promoting physical and mental health, including neuroprotection and cognitive enhancement. It has been shown to reduce stress perception, elevate mood, and improve cognitive performance both in animal models and human clinical trials. For example, a sustained-release Ashwagandha root extract (300 mg daily for 90 days) improved memory, attention, sleep quality, and psychological well-being in healthy adults without significant adverse effects. Clinical trials have also demonstrated improved working memory and social cognition in bipolar disorder patients and enhanced executive function in individuals with mild cognitive impairment, with active constituents like withanolides believed responsible for these effects.9-11
Shankhpushpi (Convolvulus pluricaulis) is extensively used in traditional Indian medicine for its neuroprotective properties, enhancing memory, speech, intellectual function, and mood.12 Experimental studies demonstrate its antioxidant and neuroprotective effects against neurotoxicity, supporting synaptic proteins and neurotransmission, which contribute to cognitive enhancement.13
Rhodiola rosea contains active flavonoids and phenolic glycosides such as salidrosides and rosavins, exhibiting adaptogenic, anti-fatigue, and cognition-enhancing effects. Chronic supplementation has been linked to reduced mental fatigue, improved attention, neuroprotection via decreased oxidative stress, and mood regulation through neurotransmitter modulation.
Celastrus paniculatus (Jyotishmati) has traditional use in cognitive enhancement and treatment of several disorders. Its seeds and oil are rich in bioactive compounds, which have shown to improve neuronal function, memory, and cognitive performance in scientific studies.14
Ginkgo biloba extract (GBE) is widely utilized in addressing age-related cognitive decline, vascular dementia, and Alzheimer’s disease. Its active constituents include flavone glycosides and terpene lactones, which improve cerebral blood flow, reduce oxidative damage, modulate neurotransmitter systems, and inhibit amyloid-beta aggregation, thus potentially delaying cognitive decline.15
Brahmi (Bacopa monnieri) is another Ayurvedic medhya rasayana herb with extensive evidence indicating improvements in memory, attention, and information processing, particularly in mild cognitive impairment and stress-related cognitive decline.16 Its bacosides support synaptic transmission, antioxidant defenses, and cholinergic function, making it a promising nootropic agent.17
Together, these constituents form the scientific basis for Suprabrain®’s neuroprotective and cognitive-supportive functions, with clinical and preclinical evidence supporting their combined use in enhancing cognitive health and reducing neuroinflammation and oxidative stress. This study was planned to evaluate efficacy and safety of Suprabrain®, a polyherbal formulation on Cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects aged 18- 70 years of either sex
- •Able and willing to provide informed consent
- •Subject experiencing subjective cognitive complaints (e.g., forgetfulness, reduced attention, mental fatigue), confirmed by clinician.
- •Subject diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Dementia, Stroke, Parkinson Disease, Alzheimer’s Disease.
- •Patient diagnosed with mild to moderate severity of the specified diagnosis.
- •Capable of completing study questionnaires with or without minimal assistance.
排除标准
- •Known hypersensitivity to ingredients of Suprabrain®
- •History of drug and alcohol abuse
- •Serious uncontrolled systemic illnesses (e.g., active infection, severe hepatic/renal impairment)
- •Participation in another clinical study within the last 30 days
- •Pregnant or lactating women.
研究者
Debasish Hota
AIIMS, Bhubaneswar
