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CTRI Number  CTRI/2020/03/023691 [Registered on: 02/03/2020] Trial Registered Prospectively
Last Modified On: 28/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of body constitution in different allergic patients. 
Scientific Title of Study   Assessment of Prakriti in the patients of Anurjata,A survey study w.s.r. वातलाद्या: सदातुरा: | 
Trial Acronym  NIA/MS/2018/SUGANDHA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sugandha 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda 
Address  Department of Maulik Siddhant Room no 102 Madhav vilas palace jorawar singh gate amer road

Jaipur
RAJASTHAN
302002
India 
Phone  8607058852  
Fax    
Email  sugandhas1992@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sugandha 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda 
Address  Department of Maulik Siddhant Room no 102 Madhav vilas palace jorawar singh gate amer road

Jaipur
RAJASTHAN
302002
India 
Phone  8607058852  
Fax    
Email  sugandhas1992@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vd Nisha Gupta 
Designation  Professor 
Affiliation  National Institute of Ayurveda 
Address  Department of Maulik Siddhant Room no 102 Madhav vilas palace jorawar singh gate amer road

Jaipur
RAJASTHAN
302002
India 
Phone  9828087640  
Fax    
Email  guptadr.nisha@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  Department of Maulik Siddhant Room no 102 Madhav vilas palace jorawar singh gate amer road 
Type of Sponsor  Research institution 
 
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 Sugandha  National institute of Ayurveda Hospital  Department of Maulik Siddhant Room no 102 Madhav vilas palace jorawar singh gate amer road
Jaipur
RAJASTHAN 
8607058852

sugandhas1992@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, (2) ICD-10 Condition: J459||Other and unspecified asthma, (3) ICD-10 Condition: L239||Allergic contact dermatitis, unspecified cause,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All acute and chronic patients suffering from different allergic disorder like allergic asthma, allergic rhinitis, skin allergy will be selected.
The sample will be between 18 to 60 years.
 
 
ExclusionCriteria 
Details  Patients with any major psychiatric illness i.e. schizophrenia, depression, epilepsy.
Patients of food allergy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the Prakriti in the prevalent population of particular allergy patients.  1.5 year 
 
Secondary Outcome  
Outcome  TimePoints 
To provide the guidelines for generating awareness regarding their food habits and lifestyle according to their prakriti with respect to allergic diseases.  1.5 year 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   02/03/2020 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The Research work is part of dissertation for the Post Graduation Degree. research work will be publish in Indexed Journal after finishing the study. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRODUCTION: -

Ayurveda the great ancient science of life defines health in terms of the body, Indriyas (sense organs), sattva (Mind) and Atma (Soul). In this ancient and holistic science of life, the concept of PRAKRITI i.e. Genetic constitution is as old as the emergence of Ayurveda along with evolution of life on earth.

This term Prakriti is derived by conjugation of the prefix Pra to verb KritiPra means the beginning, commencement or source of origin and Kriti means to perform or to form. Therefore, Prakriti means natural form or original form or original. This is a very fundamental and important concept of hidden Genotype with fully expressed phenotype designing the Ana-physio-Psychological frame of a person without any Laboratory tools and Reagents in that era of knowledge attained by Divya Chakshu (Divine means) This significant concept not only denotes the Maternal status of doshas at the time of conception but also gives the complete guidelines to be followed by the person throughout life. Also, it demonstrates about the probability of predisposition to certain doshaj vikaras and dictates about dos and don’ts by affected person.

Anurjata (Allergy) in contrary to Urja or bala (immunity) is a state of deficient energy in Ayurveda and of mistaken identity in the modern science resulting in chain of immunologically induced adverse reactions to a foreign body in the form of increased sensitivity otherwise supposed harmless. This Anurjata could be of one srotas like of Pranavaha srotas (Respiratory system) in Pratishyaya ( Rhinitis) and Shwasa roga (Asthma )or may involve more than one srotas, for example, a patient suffering from skin allergy and respiratory allergy altogether.

NEED FOR STUDY:- 

These allergic diseases are mounting day by day and the management of these reactions is still a burning challenge for medical system in current scenario. Approximately 20-30% of the Indian population suffers from at least one allergic disease.  An another cross-sectional study on the sample size of 400 was done in April 2014. In this study the prevalence of allergic rhinitis was 83(20.8%), asthma was 30(7.5%) and skin allergy was 23(5.8%). Although there is no direct reference of anurjata and Anurjata-janya diseases in Ayurvedic treatises. So now it is high time to teach the patients about their prakriti and create awareness about do’s and don’ts in allergic conditions.

AIM AND OBJECTIVES:-

To assess the Prakriti in the prevalent population of particular allergy patients.

To provide the guidelines for generating awareness regarding their food habits and lifestyle according to their Prakriti with respect to allergic diseases.

MATERIAL AND METHODS:-

A survey study on the relationship between Prakriti of the patient and various allergic diseases (anurjata) on randomly selected sample population of five hundred patients previously diagnosed or being diagnosed during survey study for allergic conditions.

To facilitate the survey study 2- 3 Allergy Awareness Camps will be organized in the NIA campus for assessment of Prakriti and for providing guidelines related to dos and don’ts regarding the lifestyle of the patient with respect to particular allergy.

Written consent would be obtained before participation from all the patients and they would be subjected for face to face interview structured on the basis of designed questionnaire and Performa incorporating different subjective parameters of Anurjata

 

Parameters

Allergic rhinitis

Skin allergy

Allergic asthma

Nasakandu (Nasal itching )

Twak kandu  (Itchy skin )

shwasa (Shortness of Breath )

Kshvathu  (Sneezing )

Twak rokshaya ( Dry skin) 

Shuska kasa  (Dry cough)

Nasasrava drava (Runny Nose- clear discharge)

Kotha  (Hives)

Ghurghuka (Wheeze )

Nasasrava ghana (Runny Nose- cloudy discharge)

Pidika (Rashes)

Vishuska mukha (Dryness of mouth) 

Nasavrodha (Stuffiness)

Twak ragima (Erythema)

 

IgE Assessment

TEC (Total Eosinophil count)


 
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