| 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
|
|
|
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
|
|
|
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. |