| CTRI Number |
CTRI/2025/02/080839 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Screening
Other (Specify) [Experimental(in-vitro) ] |
| Study Design |
Other |
|
Public Title of Study
|
IMMUNO - MODULATORY EFFECT OF HINGULA BHASMA |
|
Scientific Title of Study
|
Screening of free radical scavenging activity and immuno - modulatory effect of hingula bhasma an experimental study. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikita Pandey |
| Designation |
PG Scholar |
| Affiliation |
Shri BMK Ayurvedic college Belagavi |
| Address |
Department of Rasashastra and Bhaishajya Kalpana KAHERs Shri
BMK Ayurveda Mahavidalaya shahapur Belagavi Belgaum
KARNATAKA 590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
8617270963 |
| Fax |
|
| Email |
drnikitapandey12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P G Jadar |
| Designation |
Professor |
| Affiliation |
KLE Academy of Higher Education & Research Deemed to be University |
| Address |
Department of Rasashastra and Bhaishajya Kalpana KAHERs Shri
BMK Ayurveda Mahavidalaya shahapur Belagavi Belgaum
KARNATAKA 590003 India
Department of Rasashastra and Bhaishajya Kalpana KAHERs Shri
BMK Ayurveda Mahavidalaya shahapur Belagavi Belgaum
KARNATAKA 590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
9448301308 |
| Fax |
|
| Email |
drjadar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr P G Jadar |
| Designation |
Professor |
| Affiliation |
KLE Academy of Higher Education & Research Deemed to be University |
| Address |
Department of Rasashastra and Bhaishajya Kalpana KAHERs Shri
BMK Ayurveda Mahavidalaya shahapur Belagavi Belgaum
KARNATAKA 590003 India
Department of Rasashastra and Bhaishajya Kalpana KAHERs Shri
BMK Ayurveda Mahavidalaya shahapur Belagavi Belgaum
KARNATAKA 590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
9448301308 |
| Fax |
|
| Email |
drjadar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education Researches owned Shri B M Kankanawadi Ayurveda
Mahavidyalaya and KLE Ayurveda Hospital Shahapur, Belagavi,Pin code 590 003, Karnataka, India
|
|
|
Primary Sponsor
|
| Name |
Dr.Nikita Pandey |
| Address |
Department of Rasashastra and Bhaishajya Kalpana Shri BMK
Ayurveda Mahavidyalaya Shahpur Belagavi |
| 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 P G Jadar |
KLE Ayurveda Hospital and Medical Research Centre |
Shahapur, Belagavi pin 590 003, Karnataka, India
DEPT- Rasa shastra and bhaishajya kalpana,
DIV.- Pharmaceutical
Room No.- 4
Belgaum
KARNATAKA |
9448301308
drjadar@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committeefor Research on Human subject kahers shri B M kankanwadi AyurvedMahavidyalaya & KLE ayurved hospital shahapur , Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy adult male individuals
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: HINGULA BHASMA, Reference: Mishra sidhi nandan, yogaratnakar, chaukhambhha orientalia, edition 1st Pg-167 , Route: Oral, Dosage Form: Bhasma, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy subject |
|
| ExclusionCriteria |
| Details |
1) Metabolic disorders like Diabetic Mellitus, hypertension, immune disorders etc.
2) Subjects in the convalescent phase of any infection.
3) 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 |
| Provides part of molecular evidence on mode of action of hingul bhasma |
72 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
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)
|
05/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/03/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Hingula is Netrarogahara, kaphaprakopanasak, pittaprakopajanya, pleeharogahara, kusthahara, garavishahara and kamalaroga. It Helps in aampachan,
agnivardhak, it cures all types of prameha. It improves deha, kanti, bala and
budhi. The clinical efficacy studies have proven their indication howerver the free radical
scavenging activity and immuno-modulatory effect of Hingula Bhasma is
not yet been conducted as per our literature search. |