| 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. वातलादà¥à¤¯à¤¾: सदातà¥à¤°à¤¾: | |
| 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 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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, |
|
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Intervention / Comparator Agent
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|
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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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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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. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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 Kriti. Pra 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)
|