| CTRI Number |
CTRI/2025/07/090533 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Til Taila Pratimarsha Nasya in college going students. |
|
Scientific Title of Study
|
Effect of Til Taila Pratimarsha Nasya as a Dinacharya Upakrama in college going students -A single arm clinical study. |
| 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 KOMAL RAJESH CHATE |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya,Pune |
| Address |
Department of Swasthvritta,Tilak Ayurved Mahavidyalaya,Rasta peth,Pune
Maharashtra
411011
India
Pune
MAHARASHTRA
411011
India |
| Phone |
7972579738 |
| Fax |
|
| Email |
krchate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMihir S Hajarnavis |
| Designation |
Professor and HOD Department of Swasthvritta and Yoga |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of Swasthvritta,Tilak Ayurved Mahavidyalaya,Rasta peth,Pune
Maharashtra
411011
India
Pune
MAHARASHTRA
411011
India |
| Phone |
9422331060 |
| Fax |
|
| Email |
mihirhajarnavis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMihir S Hajarnavis |
| Designation |
Professor and HOD Department of Swasthvritta and Yoga |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of Swasthvritta,Tilak Ayurved Mahavidyalaya,Rasta peth,Pune
Maharashtra
411011
India
Pune
MAHARASHTRA
411011
India |
| Phone |
9422331060 |
| Fax |
|
| Email |
mihirhajarnavis@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya, Rasta peth, Pune-411011, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya, Rasta peth, Pune-411011, Maharashtra, India. |
| 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 |
| DrKomal Rajesh Chate |
Seth Tarachand Ramnath Charitable Ayurved Hospital |
Department of Swasthvritta
Pune
MAHARASHTRA |
7972579738
krchate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TILAK AYURVED MAHAVIDYALAYA AND SETH TARACHAND RAMNATH CHARITABLE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers of age 18-35years |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Til Taila, Reference: Charak samhita sutrasthana 13/12, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
College Students voluntarily participating in the study of age 18-35years.
Both gender will be included.
Participants with no past history of major illness before 3 months. |
|
| ExclusionCriteria |
| Details |
Participants age less than 18years and more than 35years.
Pregnant women, lactating mothers.
Participants suffering from any systemic disorder. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Til Taila Pratimarsha Nasya as a Dincharya Upakrama in college going students. |
Effect of Til Taila Pratimarsha Nasya will be assessed on day 1st,7th,15th,21st and 30th. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Understand the use of preventive aspect of Til Taila Pratimarsha Nasya as a Dincharya Upakrama |
30days |
|
|
Target Sample Size
|
Total Sample Size="30"
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)
|
01/08/2025 |
| 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="0"
Months="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Pratimarsha Nasya is a specific type of Nasya therapy that involves regular instillation of oil in nostrils.This practice has numerous health benefits,it can be specially useful for college going students who are often under high level of stress and pressure.Pratimarsha Nasya mentioned in dincharya offers a great impact on prevention of diseases and promotion of health. |