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CTRI Number  CTRI/2024/08/072467 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effecacy of Shadabindu Tail Nasya and Vyoshadi Vati in the management of Kaphaj Pratishyaya. 
Scientific Title of Study   Randomized controlled clinical study of Shadabindu Tail Nasya and Vyoshadi Vati in the management of Kaphaj Pratishyaya. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrMonali Dilip Pawar 
Designation  MD Scholar Panchakarma(Ayurveda) 
Affiliation  LRP Ayurvedic medical college and hospital 
Address  LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur sangli, Department Of Panchakarma,Unit 1,Room no.1 Sangli MAHARASHTRA 415409 India

Sangli
MAHARASHTRA
415409
India 
Phone  8378853917  
Fax    
Email  monalipawar2017@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suhas Bhagwan Mohite 
Designation  Associate professor 
Affiliation  LRP Ayurvedic medical college and hospital 
Address  Department of Panchakarma,Unit no.2,Room no.1,LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre,Is lampur,Sangli-415409 Sangli MAHARASHTRA

Sangli
MAHARASHTRA
415409
India 
Phone  9923151158  
Fax    
Email  mohitesuhas2007@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suhas Baghwan Mohite 
Designation  Associate professor 
Affiliation  LRP Ayurvedic medical college and hospital  
Address  Department of Panchakarma,Unit no.2,Room no.1,LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre,Islampur,Sangli-415409 Sangli MAHARASHTRA

Sangli
MAHARASHTRA
415409
India 
Phone  9923151158  
Fax    
Email  mohitesuhas2007@rediffmail.com  
 
Source of Monetary or Material Support  
LRP Ayurvedic Medical College and Hospital Urun Islampur Sangli Maharashtra India PIN code-415409 
 
Primary Sponsor  
Name  LRP Ayurvedic Hospital And Research Centre 
Address  LRP Ayurvedic Medical College Hospital Post Graduate Institute and Research Centre Islampur sangli Maharashtra India PIN code-415409  
Type of Sponsor  Research institution and hospital 
 
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 
DrMonali Dilip Pawar  LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre  Department of Panchakarma,Unit no.2,Room no.1,LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre,Islampur,Sangli-415409
Sangli
MAHARASHTRA 
8378853917

monalipawar2017@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  A.) Inclusive criteria:

1) Patients having symptoms more than 6 month upto 2yr will be taken.

2) Patients above age group of 15 yr should be taken.

3) Patients below age group of 60 yr should be taken.

4) Patient who are fit for nasya will be included. 
 
ExclusionCriteria 
Details  B.) Exclusion criteria:

1) Patients below 15 years and above 60 years should not be taken.

2) Patient having recently developed Pratishyaya upto 6 month(I.e. navapratishyaya) should not be taken.

3) Any fatal disease patient will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of Nasya Karma and Vyoshadi Vati in Kaphaj Pratishyaya.  14days during Morning time between 9 am to 10 am (Kapha kala gate) 
 
Secondary Outcome  
Outcome  TimePoints 
To reduce Kaphaj Pratishyaya in 14 days.
To study the literature related to concept of Kaphaj Pratishyaya.
To study the concept of Nasya Karma.
To study the concept of literature related to Vyoshadi Vati. 
12 months  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   23/08/2024 
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="0"
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   Pratishyaya is the most common disease in day to day practice. The word ’Pratishyaya itself denotes recurrence and can cause by minute etiological elements. People may be more prone to developing Pratishyaya as a result of repeated changes in climate, dust air pollution and cold beverages Pratishyaya is one of the diseases that causes immune system impairment in its chronic phase.

One of the oldest medicinal systems in the world, Ayurveda has been treating people for 2000 years Integrating and balancing the body, mind and spirit is the basic goal of Ayurveda. Five treatments in Panchakarma are required to achieve this goal. One of these is called Nasya Karma. Nasya improves the activity of sense organs and cures the disease of Uttamanga.

Shodhana is given top priority among these.lt is referenced in Charaka Sutrasthana 16/27 In other words, diseases that are treated by Shodhana don’t have a high likelihood of returning.

This fact alone demonstrates that Pratishyaya has been a significant issue for Doctors for a very long period. A fairly simple sickness that is Frequently ignored for a long period leads to recurrence. The principle Dosha that become vitiated after achieving chronicity is Vata,but the allied Doshas of Kapha, Pitta and Rakta also becomes vitiated (Su utt.24/1). The vitiated Doshas located in shirah and nasa pradesh cannot be removed without the help of Nasya Karma.

The nose is the organ that carries out olfactory and respiratory activity (B.D.Chaurasia, vol 3/193).

It is exposed to numerous micro-organisms and air borne contaminants as a result of its close proximity to the outside environment. I am choosing Shadabindu Tail Nasya as recommended in Ayurveda. Although many modern medications in this respect areundoubtedly useful, long term use can lead to dependence, negative effects and poor performance. It is anticipated.

Kaphaj Pratishyaya Roga has vital signs and symptoms are Kasa, Aruchi, Nasastrava, Prasek, Nasagaurav, Kandu. 

Kaphaj Pratishyaya is minor, if neglected it leads to major diseases for e. g.malignant pinasa, deafness, shwas, cough, dullness appetite, shopha. 

Drug mentioned in this taila are bhringraj, erand, tagar, shatawah, jivanti, rasna, dalchini, vidanga, yashtimadhu and shunti mainly having katu tikta rasa and ushna virya and Kaphvataghna property.So it is anticipated that it may helpful for the disease due to its Lekhaniya, Chhedaniya, Strotovistarak and Immunomodulatory activities. 
Nowadays, the majority of people suffer from respiratory diseases as a result of numerous environmental changes that have been noticed, including increasing exposure to environmental contamination, air pollution, climate changes, unhealthy lifestyles, urbanisation, increased mobility, and globalisation. When their nasal allergies are at their worst, people endure emotional burdens, such as fatigue and misery, and are less productive, which prevents them from doing effectively at work. Pratishyaya was chosen for the current investigation because it is widely known for its chronicity and recurrence. Nasya Karma is the greatest treatment for Urdhvajatrugata Rogas and in particular Nasagata Rogas out of all Karmas. Therefore, Nasya Karma was chosen to run Kaphaj Pratishyaya. The majority of Shadabindu tail’s medications include tikta kashaya rasatmak, ushnveerya, vatakaphaghna, stroto vispharak, and immunomodulated medications that aid in the samprapthibhang of kaphaj pratishyaya. So I am selecting Shadabindu Tail Nasya as per mentioned in ayurvedic text. The prevalence rate of Kaphaj Pratishyaya is 5%-12% in India.
 
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