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CTRI Number  CTRI/2024/06/069144 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 20/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of scientifically prepared chalcopyrite mineral ash as an immuno booster 
Scientific Title of Study   Screening of free radical scavenging activity and immuno-modulatory effect of swarnamakshika satva bhasma-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 Prashant G Jadar 
Designation  Professor 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka 
Address  Room number 2 Department of Rasashastra and Bhaishajya kalpana KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  9448301308  
Fax    
Email  drjadar@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashant G Jadar 
Designation  Professor 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka 
Address  Department of Rasashastra and Bhaishajya kalpana KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  9448301308  
Fax    
Email  drjadar@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Prashant G Jadar 
Designation  Professor 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka 
Address  Department of Rasashastra and Bhaishajya kalpana KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  9448301308  
Fax    
Email  drjadar@yahoo.co.in  
 
Source of Monetary or Material Support  
KAHER Shri B M K Ayurveda Mahavidyalaya and hospital Shahapur Belagavi karnataka India 590003 
 
Primary Sponsor  
Name  Dr Shalini Bisht 
Address  KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka 590003 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Shalini Bisht  KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka  Room number 2 Department of Swasthavritta
Belgaum
KARNATAKA 
7300616548

shalinibisht.118@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects KAHERs Shri BMK Ayurved Mahavidyalaya & KLE Ayurved Hospital Shahapur Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age between 20 to 60 years with no health issues 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: susruta sarira sthana chapter 8, Procedure details: human healthy volunteers will be taken for vein Section. Only 5ml of blood will be withdrawn from the cubital vein once. The study will be conducted on this withdrawn blood.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Healthy adult humans 
 
ExclusionCriteria 
Details  1 Metabolic disorders
2 Subjects in the convalescent phase of any inspection
3 Subjects who are on any medication within the duration of 2 to 3 months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Nitro-blue tetrazolium assay  Assessment will be done only once on the day of recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
1 Phagocytosis
2 Candidacidal assay
3 Chemotaxis
 
Assessment of all parameters will be done only once on the day of recruitment 
 
Target Sample Size   Total Sample Size="5"
Sample Size from India="5" 
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)   01/07/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Harmful free radicals (which are categorised into the reactive oxygen species (ROS) and reactive nitrogen species (RNS) can be produced either as a result of endogenous sources (mitochondria, phagocytic cells, etc.)  or exogenous sources (pollution, alcohol, tobacco smoke, heavy metals, pesticides, etc). These free radicals alter the normal redox status by adversely affecting various important classes of biological molecules such as nucleic acids, lipids, and proteins, thereby leading to increased oxidative stress which then plays an important role in immune system dysfunction leading to various diseases like rheumatoid arthritis, ulcerative colitis, asthma, cancer, cardiovascular diseases, etc. 

Many medicinal plants and minerals are known to have antioxidant & immunomodulatory properties. Swarnamashika is one amongst them. Swarnamakshika is one of the constituents of     Maharasa varga and is well known for its wide properties. There are references of  Swarnamakshika satva bhasma stating that it is a good appetizer, aphrodisiac, strengthening and intellect promoter. It cures jwara, raktapitta, ksaya, kasa and severe daha. This bhasma also possesses yogavahi and rasayana properties.

The present study intends to prepare Swarnamakshika satva bhasma by classical methods and to screen the antioxidant and immunomodulatory properties of Swarnamakshika satva bhasma by scientific method.

 
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