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CTRI Number  CTRI/2025/01/079143 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Siddha
Other (Specify) [Physical activity]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Brahmi Nei and Exercise for Treatment of Alzheimers disease 
Scientific Title of Study   A Randomized Control pilot study to test the Anti Alzheimeric efficacy of a combination of Brahmi Nei and Mild Physical Activity 
Trial Acronym  BETA  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  UMA MAHESWARI KRISHNAN 
Designation  Dean School of Arts Science Humanities Education 
Affiliation  SASTRA Deemed University 
Address  416, Centre for Nanotechnology and Advance Biomaterials, Anusandhan Kendra I, SASTRA Deemed University, Thirumalaisamudhram, Thanjavur

Thanjavur
TAMIL NADU
613401
India 
Phone  9894366263  
Fax    
Email  umakrishnan@sastra.edu  
 
Details of Contact Person
Scientific Query  
Name  UMA MAHESWARI KRISHNAN 
Designation  Dean School of Arts Science Humanities Education 
Affiliation  SASTRA Deemed University 
Address  416, Centre for Nanotechnology and Advance Biomaterials, Anusandhan Kendra I, SASTRA Deemed University, Thirumalaisamudhram, Thanjavur

Thanjavur
TAMIL NADU
613401
India 
Phone  9894366263  
Fax    
Email  umakrishnan@sastra.edu  
 
Details of Contact Person
Public Query  
Name  UMA MAHESWARI KRISHNAN 
Designation  Dean School of Arts Science Humanities Education 
Affiliation  SASTRA Deemed University 
Address  416, Centre for Nanotechnology and Advance Biomaterials, Anusandhan Kendra I, SASTRA Deemed University, Thirumalaisamudhram, Thanjavur

Thanjavur
TAMIL NADU
613401
India 
Phone  9894366263  
Fax    
Email  umakrishnan@sastra.edu  
 
Source of Monetary or Material Support  
Kauvery hospitals, Deparment of brain and spine, Kauvery Hospitals Radial road Chennai 129 
National Institute of Siddha Ayothidoss Pandither Hospital National Institute of Siddha GST Road Tambaram Sanatorium Chennai 47 
Pratiksha Trust 855 13 Main 4A Cross 3d Block Koramangala Bangalore 560034  
 
Primary Sponsor  
Name  Pratiksha Trust 
Address  855 13 Main 4A Cross 3d Block Koramangala Bangalore 560034  
Type of Sponsor  Other [Philanthropic trust] 
 
Details of Secondary Sponsor  
Name  Address 
SASTRA Deemed University  SASTRA Deemed University, Thanjavur Tamilnadu 613401 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Swathi T  Kauvery Hospital  216,Neurology OPD, 2nd Floor,Right side, Deparment of brain and spine, Kauvery Hospitals Radial road Chennai 129
Chennai
TAMIL NADU 		 9962149046

Swatsuren01@gmail.com 
G J Christian  National Institute of Siddha, Chennai  National Institute of Siddha Tambaram Sanatorium Chennai 600047
Chennai
TAMIL NADU 		 09962545930

christianvijila@gmail.com 
D Sekar  Thanjavur Medical College, Thanjavur  Neurology OPD, Department of Neurology, Thanjavur Medical College, Medical College road, Thanjavur 613004
Thanjavur
TAMIL NADU 		 9894678437

sekardr86@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Kauvery Institutional Ethics Committee  Approved 
Thanjavur Medical College Institutional Ethical Committee For Human Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G309||Alzheimers disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brahmi Nei  Brahmi Nei (8g) will be administered BD for 120 days based on the literature (Siddha vaithiya thirattu). Brahmi Nei (BN) is an Indian Sidddha formulation that has been used to treat anxiety related disorders, hypertension, depression, and cerebral palasy. One of its components, Bacopa monneiri, is widely known to confer beneficial activities against cognitive impairment. Other components include Acorus calamus, Alpinia officinarum, Operculina turpethum, Zingiber officinale, Piper longum, Phyllanthus emblica, Curcuma aromatica.  
Intervention  Brahmi Nei and Physical activity  i. Brahmi Nei twice daily 8g will be administerated for 120 days ii.The physical tasks will comprise warm up for 10 minutes, brisk walking for 10 minutes, relaxation for 10 minutes and simple yoga postures performed for 30 minutes every morning. Cognitive tasks and skilled tasks will comprise simple math tasks, word games, memory span games will be conducted every alternate evening for a duration of 60 minutes for 120 days 
Comparator Agent  Donepezil  5-10mg once daily will be administered for 120 days. FDA approved pharmacological agent for Alzheimers 
 
Inclusion Criteria  
Age From  55.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Written informed consent will be obtained from the from the subjects legal guardian and through audio visualization
Patients within the age group of 55-80 years both male and female patients
Individuals with an MMSE score of 11-20 and CDR score of 1 to 2 are eligible for the study
Hypo-metabolic changes observed through PET imaging
Hypertension less than 180 mm Hg of systolic pressure
 
 
ExclusionCriteria 
Details  Individuals with uncontrolled hypertension chronic renal disease hepatic disease and lung disease recurrent stroke
Drug alcohol and substance abuse
Patients already on other anti-dementic drugs and vascular drugs including statin therapy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cogition assesment using MMSE score, Clinical Dementia Rating Sum of Boxes and MoCA to assess the cognitive function level of AD subjects.
Hypometabolic changes in AD patients brain to confirm the pathology 		 Day 0 Questionaire and 18 FDG PET
DAY 45 Questionaire
DAY 120 Questionaire and 18 FDG PET  
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of Tau, BDNF markers in serum to determine the tau pathology and neurogenesis  DAY 0 blood based biomarker ELISA
DAY 45 Blood based biomarker ELISA
Day 120 Blood based biomarker ELISA



 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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   N/A 
Date of First Enrollment (India)   24/02/2025 
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="6"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [umakrishnan@sastra.edu].

  6. For how long will this data be available start date provided 01-04-2026 and end date provided 31-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study aims to investigate the anti-Alzheimeric efficacy of Brahmi Nei along with mild physical activity in comparison with Donepezil. Earlier,  study on rodent model of Alzheimer’s disease carried out by our group showed that the therapeutic efficacy of Brahmi Nei coupled with an enriched environment reduced tau phosphorylation, plaque accumulation, and enhanced working memory, long-term memory mitochondrial bioenergetics (https://doi.org/10.1016/j.compbiomed.2021.104999, https://doi.org/10.1002/alz.064942, https://doi.org/10.1016/j.neuint.2020.104890). Based on the promising results from the pre-clinical studies, further confirmation of the therapeutic efficacy of the combination of Brahmi Nei and physical activity for effective treatment of Alzheimer’s disease is proposed to be carried out through a pilot clinical study. The therapeutic efficiency of the combination will be compared with conventional treatment using donepezil. The primary outcome will be assessed through MMSE, CDR, MOCA and 18FDG-PET data of each participant at the beginning and the end of the study. Based on the outcomes from the pilot study, phase 2 clinical trials will be initiated so that the therapeutic benefits of this combination could be effectively used in a clinical setting to benefit affected individuals. Further, the information from the donepezil arm will provide some insights as a standard arm for comparison with data obtained from cohorts treated with Brahmi Nei individually and in combination with physical and cognitive tasks. 
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