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CTRI Number  CTRI/2024/01/062044 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 14/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Screening 
Study Design  Other 
Public Title of Study   Free radical scavenging activity and immunomodulatory effect of Mukta Pishti 
Scientific Title of Study   Evaluation of free radical scavenging activity & Immuno-modulatory effect of Mukta Pishti- An experimental 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 Elina Metia 
Designation  PG Scholar 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya Belagavi 
Address  Dept of Rasashastra and Bhaishajya Kalpana KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  8240849329  
Fax    
Email  elinametia910@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr P G Jadar 
Designation  Professor and Vice principal 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya 
Address  Dept of Rasashastra and Bhaishajya Kalpana KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  9448301308  
Fax    
Email  drjadar@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr P G Jadar 
Designation  Professor and Vice principal 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya 
Address  Dept of Rasashastra and Bhaishajya Kalpana KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  9448301308  
Fax    
Email  drjadar@yahoo.in  
 
Source of Monetary or Material Support  
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 
 
Primary Sponsor  
Name  KAHERs Shri B M K Ayurveda Mahavidyalaya  
Address  Department of Rasashastra KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi 590003 
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 Elina Metia  KLE Ayurveda Hospital and Medical Research Center shahapur Belagavi  Room number 2 Department of Swasthavritta
Belgaum
KARNATAKA 
8240849329

elinametia910@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Research on Human Subject  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Blood of Healthy Adults male 
 
ExclusionCriteria 
Details  Metabolic disorders like Diabetes Mellitus Hypertension etc
No active infection
Subjects who are on medication 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the immunomodulatory effect of Mukta pishti
Changes on Nitro blue tetra zoliun test
Changes in Phagocytes
Changes in Candid cidal essay
Changes in chemotaxis

 
0th day and 1st day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/03/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

In modern era the formation of free radicals has increased due to modern lifestyle choices in food and drug use. These cytotoxic free radicals not only increase oxidative stress but also have a significant impact on immune system function and making people more susceptible to a wide range of serious illnesses. Rajayakshma, kasa and other inflammatory or auto allergic diseases are formed due to diminished immune system. Immuno-modulation is a process which can alter the bio system of an organism by interfering with its function (by destroying pathogens) and result in an enhancement of immune reactions (increasing the body immunity).

Oxidation reaction can form free radicals which in turn start chain reaction that damages the cell. Antioxidant is a molecule which is capable of inhibiting the oxidation of other molecule. It acts at different levels such as preventive, radical scavenging, repair etc. Mukta (fresh water cultured pearl) has been chosen for the study because Mukta has its qualities like ayushya, vrishya, pushtikarana, virya-balya-buddhi vardhanam, medhya, hridya effect and its therapeutic indication includes kshaya, agnimandya, shwasa, kasa, visha vikara, rajayakshma, asthishosha, jeernajwara  etc.  Although having its broad therapeutic purpose it is not much in practice. The present study is carried out to validate Mukta pishti as an antioxidant and immunomodulator.

 
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