FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073582 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   This study explores the Memory Benefits of consuming clarified butter (Goghrita) in healthy people with different body types (Deha Prakriti) according to Ayurveda. 
Scientific Title of Study   An Exploratory study to assess the Prakriti specific response of Goghrita over Smriti in healthy individuals of different Deha Prakriti. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Km Damini Pathak 
Designation  MD scholar 
Affiliation  All India Institute Of Ayurveda 
Address  Room No- 312, Third Floor, Department Of Kriya Sharira, Academic Block, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076

South
DELHI
110076
India 
Phone  9354984993  
Fax    
Email  pathakdamini1234@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. (Dr.) Sarita Vilas Ohol 
Designation  Professor 
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA, Delhi 
Address  ROOM NO- 301, THIRD FLOOR, ACADEMIC BLOCK, ALL INDIA INSTITUTE OF AYURVEDA, GAUTAMPURI, SARITA VIHAR, NEW DELHI-110076


DELHI
110076
India 
Phone  9029765299  
Fax    
Email  drsaritav@gmail.com  
 
Details of Contact Person
Public Query  
Name  Km Damini Pathak 
Designation  MD scholar 
Affiliation  ALL INDIA INSTITUTE OF AYURVEDA, Delhi 
Address  Room No- 312, Third Floor, Department Of Kriya Sharira, Academic Block, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076

South
DELHI
110076
India 
Phone  9354984993  
Fax    
Email  pathakdamini1234@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076 
Type of Sponsor  Research institution and hospital 
 
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 Km Damini Pathak  All India Institute of Ayurveda  Room No- 312, Third Floor, Department Of Kriya Sharira, Academic Block, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI 		 9354984993

pathakdamini1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  APPERANTLY HEALTHY INDIVIDUALS 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Goghrita, Reference: charak samhita sutrasthana 27/232, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: Group B- Pittaj prakriti
2Intervention ArmDrugClassical(1) Medicine Name: Goghrita, Reference: charak samhita sutrasthana 27/232, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: Group C- Kaphaj prakriti
3Intervention ArmDrugClassical(1) Medicine Name: Goghrita, Reference: charak samhita sutrasthana 27/232, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: Group A- Vataj prakriti
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1) Apparently healthy volunteers within age group 21 – 40 years of either gender, caste and religion.
2) Volunteers willing to participate in the study.
 
 
ExclusionCriteria 
Details  1) Individual having drug and addiction (smoking & chronic alcohol intake) history.
2) Individuals consuming any kind of medications, nootropic drugs etc.
3) Pregnant and lactating women.
4) Individuals have dyslipidemia and hyperlipidemia conditions.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prakriti specific improvement in smriti assessed by using PGI memory scale  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
1) Comparative effect of goghrita on smriti of different deha prakriti assessed by using PGI memory scale
2) Assess the effect of goghrita on Agni. 		 60 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   19/02/2025 
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="3"
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  

RESEARCH QUESTION:

Is there any prakriti specific response of Goghrita over smriti in healthy individuals of different deha Prakriti?

 

HYPOTHESIS:

NULL HYPOTHESIS (H0):

There is no prakriti specific response of Goghrita over smriti in healthy individuals of different deha Prakriti.

 

ALTERNATE HYPOTHESIS (H1):

There is Prakriti specific response of Goghrita over smriti in healthy individuals of different deha Prakriti.

 NEED OF STUDY:

1) In this competitive era, every human being wants to achieve highest goal. It is being increasing necessity at the student level in schools and colleges. Furthermore, in routine life and in the social interactions too, good memory is always appreciated.

2) The modern lifestyle characterized by stress, lack of proper nutrition, sedentary habits, and excessive screen time has led to a rise in memory problems among individuals of all ages.

P3) rakriti is an important component of Dashvidha parikshya bhava, thus it is necessary to treat the patients according to Prakriti for more specific and appropriate results.

4)Goghrita having characteristics of increasing intellectual properties naturally by acting on dhatus of body.

5) As Goghrita is mentioned already in Ayurvedic Samhitas for Smriti vardhana. So, this study is planned to assess the prakriti specific response of Goghrita on smriti of apparently healthy individuals.



 
Close