| CTRI Number |
CTRI/2025/04/084914 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observation for immunomodulatory Effect in Blood sample of Healthy Human volunteers |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Can Bhallataka Ghrita help Boost Immunity? A study using Healthy human blood sample. |
|
Scientific Title of Study
|
Screening of Free radical scavenging
activity and immunomodulatory effect of Bhallataka ghrita 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 B S Gurumurthy |
| Designation |
PG scholar |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi, Karnataka 590003 |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi, Karnataka 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9113692872 |
| Fax |
|
| Email |
gurumurthybhat99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P G Jadar |
| Designation |
Professor Department of Rasa Shastra evum Bhaishajya Kalpana |
| Affiliation |
KAHERs Shri B.M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belgavi |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi, Karnataka 590003
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 Department of Rasa Shastra evum Bhaishajya Kalpana |
| Affiliation |
KAHERs Shri B.M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belgavi |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi, Karnataka 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9448301308 |
| Fax |
|
| Email |
drjadar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya & PG research centre, KLE Ayurveda Hospital & Medical Research Centre Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr B S Gurumurthy |
| Address |
PG Scholar, Department of Rasashastra and Bhaishajya Kalpana, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya, Belagavi 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 B S Gurumurthy |
KLE Ayurveda Hospital & Medical Research Centre Shahpur Belagavi Karnataka 590003 |
OPD No 18, Laboratory, KLE Ayurveda Hospital & Medical Research Centre Shahpur Belagavi Karnataka 590003
Belgaum
KARNATAKA |
9113692872
gurumurthybhat99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening for free radical scavenging and immunomodulatory effect |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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 convalescent phase of any infection
Subjects who are on any medications within the duration of 2-3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bhallataka Ghrita will show free radical scavenging activity and immuno-modulatory effect |
Baseline only |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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) |
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
Modification(s)
|
The presence of harmful free radicals, which include reactive oxygen species (ROS) and reactive nitrogen species (RNS), can lead to a condition called oxidative stress. These free radicals originate from sources within the body, like mitochondria and immune cells or even from external factors such as pollution, smoking and exposure to heavy metals or pesticides. Oxidative stress occurs when there is an imbalance between the production of free radicals and the body’s ability to neutralize them with antioxidants. This process plays a major part in the development of chronic and degenerative illness such as cancer, autoimmune disorders, ageing, cataract, rheumatoid arthritis, cardiovascular and neurogenerative disorders. Immunomodulation is a process which alters the immune system of organism by interfering with its function by immuno-stimulation or immuno-suppression. Modulation of immune responses to alleviate the disease using herbal, mineral or herbo-mineral has been of interest for many years and the concept of ‘Rasayana’ is based on related principles. Bhallataka is proven to have anti-inflammatory, antioxidant activity, anticancer activity, and antibacterial activity as well as the Rasayana (rejuvenating) properties when used in different dosage forms. Ghrita increases the potency of certain herbal ingredients by carrying the lipid soluble active components to the interior of the cell. Since the drug is mentioned under semi-poisonous group of drugs, judicious use of Bhallataka after proper processing is advocated. Other studies related to phytochemistry revealed the presence of a variety of flavonoids such as tetrahydroamentoflavone, nallaflavanone, semecarpetin and anacardioflavanone along with other phenolic compound such as bhilawanol and anacardic acid. The present study intends to prepare Bhallataka Ghrita by classical method and to screen the antioxidant and immunomodulatory properties of Bhallataka Ghrita in a scientific manner. |