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CTRI Number  CTRI/2025/03/082646 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 04/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on Pesticide exposure and its effects on health 
Scientific Title of Study   Evaluating exposure of chemical pesticide and its health implications with special reference to Garavisha in farmers of Eastern UP 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita Sahani 
Designation  Student 
Affiliation  Guru gorakshath institute of medical sciences  
Address  Department of Agada Tantra evam Vidhivaidyaka, Room No:44, 2nd Floor, Guru Gorakshnath institute of medical sciences, Arogyadham, Balapar Road,Sonbarsa,Gorkhpur

Gorakhpur
UTTAR PRADESH
273007
India 
Phone  8423041983  
Fax    
Email  ay01210011@mgug.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Reshmi Pushpan 
Designation  Professor 
Affiliation  Guru Gorakshnath Institute of Medical sciences 
Address  Department of Agada Tantra evam Vidhivaidyaka, Room No:44, 2nd Floor, Guru Gorakshnath Institute of Medical Sciences, Arogya Dham, Sonbarsa,Balapar Road, Gorakhpur

Gorakhpur
UTTAR PRADESH
273007
India 
Phone  8289933175  
Fax    
Email  reshmi.pushpan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Reshmi Pushpan  
Designation  Professor 
Affiliation  Guru Gorakshnath Institute of Medical Sciences 
Address  Department of Agada Tantra evam Vidhivaidyaka, Room No:44, 2nd Floor, Guru Gorakshnath Institute of Medical Sciences, Arogya Dham, Sonbarsa,Balapar Road, Gorakhpur

Gorakhpur
UTTAR PRADESH
273007
India 
Phone  8289933175  
Fax    
Email  reshmi.pushpan@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  Jawaharlal Nehru Bharatiya Chikitsa evam Homeopathy Anusandhan Bhawan, 61-65, opp. D Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi, 110058 
Type of Sponsor  Government funding agency 
 
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 Ankita Sahani  Guru gorakshnath institute of medical sciences  Department of Agada Tantra evam Vidhivaidyaka, Room No:44, 2nd Floor, Guru Gorakshnath Institute of Medical Sciences, Mahayogi Gorakhnath University Campus, Arogya dham, Balapar Road, Sonbarsa, Gorakhpur-273007
Gorakhpur
UTTAR PRADESH 
8423041983

ay01210011@mgug.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Studies of GGIMS and MDAC of MGUG  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Farmers with exposure to chemical pesticides during the past 1 year 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Farmers with exposure to chemical pesticides in the past 1 year
2. Voluntary consent to participate in the study 
 
ExclusionCriteria 
Details  1. Volunteers who are suffering from cancer, chronic neurological diseases, diabetes mellitus, cardiovascular diseases and on medications for these conditions
2. Pregnant women
3. Volunteers who are using natural pesticides or involved in organic farming 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Exposue to chemical pesticides(Gara visha) and its clinical presentation- single point  Baseline Visit: Week 0- single point 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/04/2025 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   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   Pesticides are substances that are used to control pests. These include herbicides, insecticides,
nematicides, fungicides, and many others. Acute effects of pesticides exposure includes
headache, stinging of eyes and skin irritation of nose and throat, skin itching, appearance of rash
and blisters on skin, dizziness, diahhorea, abdominal pain, nausea and vomiting, blurred vision,
blindness1
. Chronic effects of pesticides are neurological health effects like loss of memory,
leukaemia, brain cancer, lymphoma, breast cancer etc. Direct effect of pesticides, long term and
low dose exposure is increasingly linked to human health effects such as immune suppression,
hormone disruption, diminished intelligence, reproductive abnormalities2
. Indirect effects are the
pesticides enter those through water via drift, by runoff, leaching through the soil or may be
applied directly into surface water. Pesticide contaminated water pose great threat to aquatic
form of life which can enter into food chain and thence to humanbeings. Thus pesticides enters
the human body through ingestion, inhalation and dermally. Agriculture is the primary income
source for 70 % of rural households in India India is now second largest manufacturer of
pesticides in Asia3
. Human poisoning by pesticides has long been seen as a severe public health
problem. Whilst numerous small surveys of pesticide poisoning have been published there are no
updated estimates for pesticide poisoning from this region of India 4
.
Ayurveda describes three varieties of Visha, i.e., Jangama (animal origin), Sthavara (plant and
mineral origin) and Kritrima (artificial poison)5
. Kritima visha, synonymous of Garvisha is an
Ayurvedic concept of cumulative toxicity, or a slow-acting poison that can build up in the body
over time6
,
7Exposure to adulterants, preservatives, chemical cosmetics,personal care products,
drug toxicity, pesticide exposure can all be considered as sources of Gara visha . Signs and
symptoms produced by Gara Visha are pallor ,emaciation , weak digestive capacity , cough,
dyspnoca, fever , upword movent of Vaata , increased sleep and worry , Ascites, liver and spleen
diseases , Weakness, lethargy and difficulty in speech , inflammation, swelling, flatulence
,wasting of extrimities , body heaviness, yawning , loose stools, foul breath, impaired senses of
taste and smell, vomiting, diarrhea, discoloration , skin issues like red patches, urticaria, edema,
mental health issues like slurred speech, depression, fainting , other symptoms like indigestion,
anorexia, and excessive thirst8,9
. On categorising these symptoms it becomes clear that repeated
exposure to Gara visha seems to affect important body systems such as the immune system,
endocrine system, digestive system, nervous system, and circulatory Systems with chronic health
implications.
Factors that aggravate toxicity in the body are identified as polluted land, polluted water,
polluted soil. Currently there is paucity of evidence on the exposure to pesticide and its health
implications with special reference to Gara visha .
 
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