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CTRI Number  CTRI/2026/03/106477 [Registered on: 18/03/2026] Trial Registered Prospectively
Last Modified On: 16/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Suprabrain®, A Polyherbal Formulation on Memory 
Scientific Title of Study   A Randomized Double-blind Placebo-Controlled Trial To Evaluate Efficacy And Safety Of Suprabrain®, A Polyherbal Formulation On Cognitive Function 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Debasish Hota 
Designation  Professor and Head 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Pharmacology 1st Floor, Academic Block

Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Debasish Hota 
Designation  Professor and Head 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Pharmacology 1st Floor, Academic Block

Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query
 
Name  Debasish Hota 
Designation  Professor and Head 
Affiliation  AIIMS, Bhubaneswar 
Address  Department of Pharmacology 1st Floor, Academic Block

Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
M/s Enkel Technology, Bengaluru 
 
Primary Sponsor  
Name  M/s Enkel Technology 
Address  K No 1339/198/2/35/1340/198/2/34, Okotha Thanisandra Village, Bangalore, Karnataka, India, 560077 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Debasish Hota  All India Institute of Medical Sciences, Bhubaneswar  Department of Pharmacology 1st Floor, Academic Block
Khordha
ORISSA 
9438884190

pharm_debasish@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G988||Other disorders of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Twice a day for 12 weeks 
Intervention  Suprabrain  [containing extracts of Jyotisha mati 100mg, Shankspuspi 100 mg, Ashwagandha 50 mg, Brahmi 100 mg, Ginkgo biloba 50 mg and Rhodiola Rosea 100 mg] 500 mg twice a day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects aged 18- 70 years of either sex
2. Able and willing to provide informed consent
3. Subject experiencing subjective cognitive complaints (e.g., forgetfulness, reduced attention, mental fatigue), confirmed by clinician.
4. Subject diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Dementia, Stroke, Parkinson Disease, Alzheimer’s Disease.
5. Patient diagnosed with mild to moderate severity of the specified diagnosis.
6. Capable of completing study questionnaires with or without minimal assistance.
 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to ingredients of Suprabrain®
2. History of drug and alcohol abuse
3. Serious uncontrolled systemic illnesses (e.g., active infection, severe hepatic/renal impairment)
4. Participation in another clinical study within the last 30 days
5. Pregnant or lactating women
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in Mini Mental Scale Examination  0, 4, 8 and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Cognitive failure questionnaire, Pittsburgh sleep quality index, Depression Anxiety Stress Scales - 10 item version, WHOQOL-BREF, PSS-10, Anxiety self-rating scale, Serum BDNF, serum NGF.  0, 4, 8 and 12 weeks  
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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