| CTRI Number |
CTRI/2023/07/055213 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
13/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effectiveness of medicated oil administration through nose on nasal flora of healthy individuals |
|
Scientific Title of Study
|
A Clinical Study To Evaluate the Effectiveness of Pratimarsha Nasya with Anu Taila on Nasal Flora of Healthy Individuals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopesh Virmani |
| Designation |
Department of Panchakarma |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
OPD no. 5 Department of Panchakarma ,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9467211800 |
| Fax |
|
| Email |
gopesh.virmani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopesh Virmani |
| Designation |
Department of Panchakarma |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
OPD no. 5 Department of Panchakarma ,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9467211800 |
| Fax |
|
| Email |
gopesh.virmani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lohith BA |
| Designation |
Department of Panchakarma |
| Affiliation |
Sri Dharnasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
OPD no.5 Department of Panchakarma, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9886749168 |
| Fax |
|
| Email |
drlohithpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
College Phone: 08172256460
Email: sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
College Phone: 08172256460
Email: sdmcah@gmail.com |
| Type of Sponsor |
Private medical college |
|
|
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 Gopesh Virmani |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
OPD no. 5 Department of Panchakarma, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
College Phone: 08172256460
Email: sdmcah@gmail.com
Hassan
KARNATAKA |
9467211800
gopesh.virmani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India College Phone: 08172256460 Email: sdmcah@gmail.com |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects without any history of acute or chronic respiratory diseases |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Charaka samhita Siddhi Sthana 9/88, Procedure details: 30 healthy individuals will be taken in one group will be given Pratimarsha Nasya with Anu taila three times a day for 7 days (Prabhate- after waking up 7:30 to 8:30 am, Bhojanaante- after lunch 1:30 to 2:30 pm & Sayana kala- before sleeping 8:30 to 9:30 pm))
(1) Medicine Name: Anu Taila, Reference: Charaka Samhita Sutra Sthana 5/53-63, Route: Nasal, Dosage Form: Taila, Dose: 20(drops), Frequency: tds, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aging between 18 to 50 years
2. Subjects of all gender
3. Subjects without any history of acute or chronic respiratory diseases
4. Subjects who are fit for Pratimarsha Nasya
5. Subjects willing to sign informed consent form |
|
| ExclusionCriteria |
| Details |
1. Subjects with history of nasal polyp, Deviated nasal septum, any acute or chronic respiratory illness
2. Subjects with chronic systematic diseases like HIV, HBsAg etc
3. Subjects vaccinated with Covid Vaccine in last three months
4. Subject having history of antibiotics intake in last three months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time taken to achieve Samyaka Lakshanas of Nasya will be observed:
1.Urah Laghavam (Lightness in chest region)
2.Shiro Laghavam (lightness in head region)
3.Indriyaatacchyam (clearity of sesnse organs)
4.Sroto Vishudhi (clearance of bodily channels)
|
Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Respiratory health of subjects will be analyzed using MRC Breathlessnes Scale
The collected swab samples will be analyzed for the number and variety of microorganisms present in the nasal flora |
Swab sample will be taken before treatment and after treatment on 8th day |
|
|
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 |
|
Date of First Enrollment (India)
|
15/08/2023 |
| 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="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open label, single arm, prospective, clinical study to evaluate the effectiveness of Pratimarsha Nasya with Anu Taila on Nasal Flora of Healthy Individuals that will be conducted in India. The primary outcome measures will be samyaka lakshanas of Nasya that will be assessed before treatment and everyday of Nasya for 7 days and after Nasya on 8th day. Respiratory health of subjects will be analyzed using MRC Breathlessness Scale. The secondary outcome measures will be the collected swab samples to analyze number and variety of microorganisms present in the nasal flora and this will be assessed before and after treatment |