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CTRI Number  CTRI/2025/04/084948 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   experimental study 
Study Design  Other 
Public Title of Study   To Study the Effect of Gagana Parpati 
Scientific Title of Study   Screening of Free Radical Scavening Activity And Immunomodulatory Effect of Gagan Parpati 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  Saurabh 
Designation  BAMS 
Affiliation  KLE university 
Address  Department of Rasashastra KLE Shri BMK Ayurvda Mahavidyalaya Belgavi
Department of Rasashastra KLE Shri BMK Ayurvda Mahavidyalaya Belgavi
Belgaum
KARNATAKA
59003
India 
Phone  08628846501  
Fax    
Email  s.s561756247@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  prashant g jadar 
Designation  professor  
Affiliation  KLE university 
Address  Department of Rasashastra KLE Shri BMK Ayurvda Mahavidyalaya Belgavi
Department of Rasashastra KLE Shri BMK Ayurvda Mahavidyalaya Belgavi
Belgaum
KARNATAKA
590003
India 
Phone  9448301308  
Fax    
Email  drjadar@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Saurabh 
Designation  BAMS 
Affiliation  KLE university 
Address  Department of Rasashastra KLE Shri BMK Ayurvda Mahavidyalaya Belgavi
Department of Rasashastra KLE Shri BMK Ayurvda Mahavidyalaya Belgavi
Belgaum
KARNATAKA
590003
India 
Phone  08628846501  
Fax    
Email  s.s561756247@gmail.com  
 
Source of Monetary or Material Support  
Department of Rasashastra KLE Shri BMK Ayurvda Mahavidyalaya Shahapur Belagavi Karnataka 590003 India 
 
Primary Sponsor  
Name  Saurabh 
Address  Department of Rasashastra KLE Shri BMK Ayurvda Mahavidyalaya Shahapur Belgavi 590003 Karnataka India 
Type of Sponsor  Private medical college 
 
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 Saurabh  KLE Ayurveda Hospital  Department of Rasashastra KLE Shri BMK Ayurvda Mahavidyalaya Belgavi
Belgaum
KARNATAKA 		 8628846501

s.s561756247@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Ethics Committee for Research on Human Subjects KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya & KLE Ayurveda Hospital Shahapur Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Screening 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  healthy adult humans 
 
ExclusionCriteria 
Details  Metabolic disorders like Diabetes mellitus, hypertension, immune disorders, etc
Subjects in the convalescent phase of any infection.
Subjects who are on any medications within the duration of 2 to 3 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Nitroblue tetrazolim assay for respiratory burst.
2. Phagocytosis for phagocytic function.
3. Candidal assay for phagocytic function.
4. Chemotaxis to assess the motility of phagocytic cells.  		 1st day 
 
Secondary Outcome  
Outcome  TimePoints 
imuunne responses  within 15 days 
 
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   N/A 
Date of First Enrollment (India)   28/05/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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   Free radicals are the type of unstable molecule that is made during normal cell metabolism. The ability of the oxygen-food combination to release that is used in many energy-dependent processes means that oxygen can be transformed into a variety of potentially toxic reactive intermediates known as oxygen-free radicals. Their production occurs during the absorption of radiation, activation of phagocytic cells, interaction with cells, automobile exhaust fumes, smoking of cigarettes, and burning of organic matter during cooking. Thus, the availability of free radicals creates oxidative stress in the body, which in turn plays a significant role in immune system dysfunction leading to various diseases like rheumatoid arthritis, ulcerative colitis, asthma, etc. These free radicals can damage the body DNA, proteins, lipids, and cell membranes; hence, they can also cause cancer by doing mutations in Tumour suppressor genes that can lead to cancer cell formation. Countless of the Rasashastra mineral formulations are known to have an antioxidant & immunomodulatory effect. Gagan parpati is a type of parpati kalpana (thin flaked size—herbo-mineral formulation) that works best for G.I.T. diseases. It works well in Pandu, kshaya, kasa, shwasa, ghrani roga, etc The present study intends to prepare Gagana parpati by classical method and to screen the antioxidant and immunomodulatory properties of Gagana parpati by scientific method.

 
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