| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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. |