| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age between 20 to 60 years with no health issues |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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. |