| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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. |