| CTRI Number |
CTRI/2024/08/071823 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| 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 Effect Of Pathadi Taila Nasya In The Management Of Jeerna Pratishyaya. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Study The Efficacy Of Pathadi Taila Nasya In The Management Of Jeerna 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 |
Dr.Deepak Kumar Parida |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
LRP AYURVEDIC MEDICAL COLLEGE AND HOSPITAL POST GRADUATE INSTITUTE ISLAMPUR SANGLI
Department of Panchakarma, Unit 1, Room no.1
Sangli
MAHARASHTRA
415409
India |
| Phone |
8830333050 |
| Fax |
|
| Email |
dpkparida@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Deepak Kumar Parida |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
LRP AYURVEDIC MEDICAL COLLEGE AND HOSPITAL POST GRADUATE INSTITUTE ISLAMPUR SANGLI
Department of Panchakarma, Unit 1, Room no.1
Sangli
MAHARASHTRA
415409
India |
| Phone |
8830333050 |
| Fax |
|
| Email |
dpkparida@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR DEEPAK KUMAR PARIDA |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
LRP AYURVEDIC MEDICAL COLLEGE AND HOSPITAL POST GRADUATE INSTITUTE ISLAMPUR SANGLI
Department of Panchakarma, Unit 1, Room no.1
Sangli
MAHARASHTRA
415409
India |
| Phone |
8830333050 |
| Fax |
|
| Email |
dpkparida@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital Post Graduate Institute Islampur Sangli-415409, Mharashtra,India |
|
|
Primary Sponsor
|
| Name |
Dr Deepak Kumar Parida |
| Address |
LRP AYURVEDIC MEDICAL COLLEGE AND HOSPITAL POST GRADUATE INSTITUTE ISLAMPUR SANGLI. |
| Type of Sponsor |
Other [Professor] |
|
|
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 |
| Dr Prashant Shankarrao Gore |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre |
LRP AYURVEDIC MEDICAL COLLEGE AND HOSPITAL POST GRADUATE INSTITUTE ISLAMPUR SANGLI
Department of Panchakarma, Unit 1, Room no.1
Sangli
MAHARASHTRA |
9970310053
prashantgore6100@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:J011||Acute frontal sinusitis. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: SHARANGDHAR SAMHITA, Procedure details: PurvaKarma :
1.Prior of Nasya snehan will be done on face forehead ears & neck with
Tila taila aproximataly for 5 minutes
2.Sthanik swedan
Pradhan karma:
1)Supine position with slightly extended neck
2)Drug will be instilled in to nostril while kept closed the same possess is
carried out in other nostril also.
3) for administration of drug dropper will be used.
Pashchat karma:
Gandush with lukewarm water.
)
(1) Medicine Name: PATHADI TAILAM, Reference: SHARANGDHAR SAMHITA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: YOGRATNAKAR, Procedure details: PurvaKarma : 1.Prior of Nasya snehan will be done on face forehead ears and neck with Tila taila aproximataly for 5 minutes 2.Sthanik swedan Pradhan karma 1)Supine position with slightly extended neck 2)Drug will be instilled in to nostril while kept closed the same possess is carried out in other nostril also. 3) for administration of drug dropper will be used. Pashchat karma Gandush with lukewarm water))
(1) Medicine Name: SHADABINDU GHRITA, Reference: YOGRATNAKAR, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patient having history of symptoms of Nasastrav(Nasal discharge); Kshavatu (sneezing); Shirshool (headache); Shirogaurav (heaviness in head); Nasaavrodh (nasalobstruction). Patients between 18 years to 60 years of age.for more than 2 months and less than 1 years. |
|
| ExclusionCriteria |
| Details |
Nav-pratishyaya
Patients below 18 years and above 60 years.
Patients having any complicated Nasal disease were excluded.
Nasyaayogya |
|
|
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 Effect Of Pathadi Taila Nasya In The Management Of Jeerna Pratishyaya. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce Jeerna Pratishyaya in 21 days.
To Study the literature related to concept of Jeerna Pratishyaya.
To Study the concept of Nasya karma.
To study the concept of Pathadi Taila. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="30"
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)
|
12/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/08/2024 |
| 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
|
Pratishayaya is the most common disease in day today practice. Pratishyaya word itself indicates that it is recurrence and can participate due to minute etiological factors due to repetitive changes in climate dust air pollution cold beverages people may be more prone to having pratishayaya. Pratishayaya is one of the disease which leads to immune compromised condition in its chronic phase it is characterised by nasastrav, kshavathu, nasavarodha, shrishool etc, Ayurveda has the nasya theropy as master key for nasaroga, Medicine administered through the nose enterd into the head and expel the vitiated doshas.
This fact itself shows that jeerna Pratishyaya has been a major problem to the physician, since long time. Being considered very simple disease is usually neglected for a long time, for which it occures again again which converted to jeernavstha which known as jeernpratishyaya. |