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CTRI Number  CTRI/2024/08/072293 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of brahmi churna in smrutibransha (senile dementia) 
Scientific Title of Study   A randomized controlled clinical trial to study the effect of brahmi churna in smrutibransha with special reference to senile dementia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Snehal Deorao Wasekar 
Designation  Post Graduate Student 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Kayachikitsa SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik Maharashtra 422403

Nashik
MAHARASHTRA
422403
India 
Phone  9527122239  
Fax    
Email  snehaldwasekar17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hiraman Nivrutti Warungase 
Designation  Professor & Head of department 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Kayachikitsa SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India Maharashtra 422403

Nashik
MAHARASHTRA
422403
India 
Phone  9420364157  
Fax    
Email  hiramanwarungase@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Snehal Deorao Wasekar 
Designation  Post Graduate Student 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Kayachikitsa SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik Maharashtra 422403


MAHARASHTRA
422403
India 
Phone  9527122239  
Fax    
Email  snehaldwasekar17@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 
 
Primary Sponsor  
Name  Dr Snehal Wasekar 
Address  Department of Kayachikitsa SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India  
Type of Sponsor  Other [Self] 
 
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 
Dr Snehal Wasekar  SMBT Ayurved College and Hospital  OPD No 10 Department of Kayachikitsa SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashrta India
Nashik
MAHARASHTRA 		 9527122239

snehaldwasekar17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT Ayurved College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F70||Mild intellectual disabilities. Ayurveda Condition: smrit,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Bramhi Churna, Reference: Bhavaprakasa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -GHRITA), Additional Information: -
2Comparator Arm (Non Ayurveda)-Donepezil5mg with water BD After food for 45 days
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients having cardinal features of Senile Dementia.
2. Patients having age between 60 to 80 years.
3. Patients having - MMSC scoring 18-23 (Mild cognitive impairment).
 
 
ExclusionCriteria 
Details  1. Patients with known case of delirium, confusion or other disturbances of consciousness, Parkinson’s disease, stroke, intracranial hemorrhage, brain tumors, recent history of alcoholism or drug dependence, use of any psychotropic drug, diabetes mellitus, etc.
2. Patients with physical impairment, such as walking, sitting, and holding one’s head up and eventually, results in difficulty in swallow, unable to control the micturition and feces.
3. Patients with loss of ability to communicate.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in score of minimental state examination and sign and symptoms of smruthibhransha  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Where the trial group stands in comparison with control group  18 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   17/08/2024 
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="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  

-     Smruti is the remembrance of things by concentrated mind, directly perceived, heard or experienced earlier. If the person is not able to grasp or retain the present events or experiences, it is known as ‘Smrutivibhransa’. When the mind of any person is covered by the Rajasa and Moha its activities are being taken to such an extent that one cannot be able to recollect the memory stored as it is related to Tatvagyana. This condition is termed as ‘Smrutibransha’ which can be correlated with Senile Dementia in modern science. Dementia is a chronic organic mental disorder, characterized by progressive usually irreversible, global cognitive deficit. It is a condition in which one’s thinking and remembering ability gradually hampers. The estimated Senile dementia prevalence for adults ages 60 above in India is 7.4%. Brahmi Churna has been selected as it is tiktarasatmak, laghugunatmak, sheetvirya , madhuraviryatmak ,vaatpittaharka , medhya rasayan. It primarily either acts via antioxidant mechanism (i.e., neuroprotection) or alters different neurotransmitters (serotonin (5-hydroxytryptamine, 5-HT), dopamine (DA), acetylcholine (ACh), γ-aminobutyric acid (GABA)) to execute the pharmacological effect. The patients within the age group of 60-80 years who fulfill the clinical assessment criteria for senile dementia & having symptoms of Smrutibransha mentioned in the classics, patients are selected irrespective of sex, socio-economic status, and community, written consent from both patient and their relatives will be taken prior to the study. Computerised generated sampling technique will be used. Total 60 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (Control group).Brahmi Churna Group A (trial group)  with dose 3gm bd with anupana goghrit and Tablet Donepezil Group B(Control group) with dose 5mg will be given to patients. Both drugs will be administered in churna form & tablet respectively for 45 days. Observations will be done on day 0, day 15, day 30 and day 45. Result of study will be drawn on basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased.

 
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