FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070223 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 28/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Trikatu churna and Brahmi ghrita in Mild Cognitive Impairment 
Scientific Title of Study   Evaluation of Trikatu churna and Brahmi ghrita in Mild Cognitive Impairment: A Pre and Post test clinical study 
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 Saurav Sharma 
Designation  PG scholar 
Affiliation  Amrita School Of Ayurveda 
Address  Department of Kayachikitsa, Amrita school of ayurveda, Amritapuri Campus, Clappana, P.O. Kollam

Kollam
KERALA
690525
India 
Phone  07018326775  
Fax    
Email  am.ay.p3kca22008@ay.students.amrita.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr C Nagarajan 
Designation  Dean, Professor,HOD department of Kayachikitsa 
Affiliation  Amrita School Of Ayurveda 
Address  Department of Kayachikitsa, Amrita school of ayurveda, A Amritapuri Campus, Clappana, P.O. Kollam.
.
Kollam
KERALA
690525
India 
Phone  9447498812  
Fax    
Email  sankara@ay.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Dr C Nagarajan 
Designation  Dean, Professor,HOD department of Kayachikitsa 
Affiliation  Amrita School Of Ayurveda 
Address  Department of Kayachikitsa, Amrita school of ayurveda, A Amritapuri Campus, Clappana, P.O. Kollam.
.
Kollam
KERALA
690525
India 
Phone  9447498812  
Fax    
Email  sankara@ay.amrita.edu  
 
Source of Monetary or Material Support  
Amrita School of Ayurveda Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O. Kerala, India – 690525 
 
Primary Sponsor  
Name  Dr Saurav Sharma 
Address  Amrita school of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri Campus, Clappana, P.O. Kollam - 690525 kerala, India. 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saurav Sharma  Amrita School Of Ayurveda  Department of Kayachikitsa, Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O. Kerala, India – 690 525
Kollam
KERALA 		 7018326775

am.ay.p3kca22008@ay.students.amrita.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Amrita School of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R419||Unspecified symptoms and signs involving cognitive functions and awareness. Ayurveda Condition: SVABAVIKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Trikatu churna, Reference: Sushruta samhita sutra sathana chapter 38 shaloka 58-59, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: 1-3g of the churna will be given based on the condition of the patients
(2) Medicine Name: Brahmi ghrita, Reference: Ashtanga Hrudayam Uttar sthana chapter 6 shaloka 23-25, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information:
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. People between 60 – 80 years of age.
2. MoCA SCALE ASSESSMENT ranges from 16 – 26 points  
 
ExclusionCriteria 
Details  1. Pre diagnosed neurological (seizures, vascular accidents, Parkinson’s disease) and psychiatric diseases (schizophrenia, mania, depression, delirium).
2. Pre diagnosed with chronic infection.
3. Pre diagnosed cases of thyroid disorders.
4. Patients with electrolyte imbalance.
5. Who are on cholinesterase inhibitors or glutamatergic drugs.
6. Individuals on medication having fasting Plasma glucose levels above 126 mg/dl and uncontrolled post prandial above 160 mg/dl.
7. Individuals on medication having Blood pressure above 150/90 mm hg.
8. Individuals on medication having Total Cholesterols level above 190mg/dl.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the cognitive functions as on MoCA Scale.  97 days 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   26/07/2024 
Date of Study Completion (India) 21/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 21/10/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   This study is a single-arm, open-label pre-and post-test, designed to evaluate the effectiveness of a combination of Trikatu Churna and Brahmi Ghrita in patients with MCI, aged between 60 to 80 years, over a period of 97 days. The outcome will be measured based on changes in the MoCA scale. 
Close