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CTRI Number  CTRI/2024/08/072609 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Examination of exposure of bacteria before and after Administration of medicated oil through nostrils in participants of Rhinitis  
Scientific Title of Study   Clinical Study To Evaluate The Efficacy Of Marsha Nasya With Shadbindu Taila On Nasal Flora In Pratishyaya(Rhinitis) 
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 Ankita Das 
Designation  PG 2nd year Scholar, Department of Panchakarma 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Hassan 
Address  OPD No.5, Panchakarma OPD, SDM Hospital, BM Road, Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9579574322  
Fax    
Email  ankitaadas1804@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashvini Kumar M 
Designation  Professor & Head, Department of Panchakarma 
Affiliation  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital 
Address  Department of Panchakarma, Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital BM road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9448705660  
Fax    
Email  drashvinikumarm@sdmcahhassan.org  
 
Details of Contact Person
Public Query  
Name  Dr Ashvini Kumar M 
Designation  Professor & Head, Department of Panchakarma 
Affiliation  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital 
Address  Department of Panchakarma, Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital BM road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9448705660  
Fax    
Email  drashvinikumarm@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan, BM Road, Thanniruhalla District- Hassan 573201 Karnataka, India 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital 
Address  BM road Thanniruhalla Hassan Karnataka pin code - 573201 India  
Type of Sponsor  Private medical college 
 
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 
Dr Ankita Das  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital  SDM Hassan Hospital Laboratory
Hassan
KARNATAKA 		 9579574322

ankitaadas1804@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: charaka siddhisthana, Procedure details: Nasal swab will be collected and cultured, before starting Marsha Nasya and on 8th day, after the course of treatment in order to evaluate the change in number of microorganisms present in nose. The swab will be cultured and analyzed at microbiology laboratory.)
(1) Medicine Name: shadabindu taila, Reference: bhaishaj ratnavali shirorogadhikara, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: bd, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants fulfilling the diagnostic criteria 20-60 years of either gender.
Participants who are ready to sign the informed consent. Participants who are diagnosed with pratishyaya and are fit for Nasya. 
 
ExclusionCriteria 
Details  Pregnancy and lactating women
History of nasal polyp, Deviated nasal septum, any chronic respiratory illness.
History of antibiotics intake in last three months
Diagnosed cases of systemic disorders like chronic heart disease, chronic renal failure and chronic liver disease.
Diagnosed cases of HIV, HBsAg, Carcinoma and Tuberculosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The subjective and Objective parameters of baseline data to post medication data compared for assessment of the final results.
The collected swab samples will be analysed for the number and variety of microorganisms. 		 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the improvement in quality of life  improvement in quality of life will be assessed for
7 days 
 
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)   27/08/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   It’s important to note that the relationship between nasal flora and rhinitis is complex and not fully understood. Research in this area continues to explore how changes in nasal flora may contribute to the development or exacerbation of rhinitis and how restoring microbial balance might influence treatment outcomes. So , treatment like Marsha Nasya with Shadbindu Taila is being studied for their potential to modulate nasal flora and alleviate rhinitis symptoms 
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