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CTRI Number  CTRI/2023/07/054634 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 01/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the efficacy of nasal spray made up of drugs of anuthaila against nasal administration of anuthaila in longstanding sinusitis 
Scientific Title of Study   Efficacy of Nasal spray made of selected drugs of Aṇutaila against Nasya of Aṇutaila in Chronic sinusitis – A Randomised Controlled Noninferiority Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr PRIYA NK 
Designation  PG SCHOLAR  
Affiliation  VPSV Ayurveda College, Kottakkal  
Address  Department of Panchakarma VPSV Ayurveda College Kottakkal

Malappuram
KERALA
676501
India 
Phone  8547357368  
Fax    
Email  dr.priyankayu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Binitha A 
Designation  Professor  
Affiliation  VPSV Ayurveda College, Kottakkal  
Address  Department of Panchakarma VPSV Ayurveda College Kottakkal

Malappuram
KERALA
676501
India 
Phone  9895201635  
Fax    
Email  drbinithaunni@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Binitha A 
Designation  Professor  
Affiliation  VPSV Ayurveda College, Kottakkal  
Address  Department of Panchakarma VPSV Ayurveda College Kottakkal

Malappuram
KERALA
676501
India 
Phone  9895201635  
Fax    
Email  drbinithaunni@gmail.com  
 
Source of Monetary or Material Support  
Arya Vaidya Sala Kottakkal GMP certified Institute  
 
Primary Sponsor  
Name  Vaidyaratnam PS Variers Ayurveda College Kottakkal 
Address  Vaidyaratnam PS Variers Ayurveda College Kottakkal EDARIKODE PO KOTTAKKAL KERALA 676501 
Type of Sponsor  Other [Aided 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 Priya N K   VPSV AYURVEDA COLLEGE   OPD Department of Panchakarma Room number A112
Malappuram
KERALA 		 8547357368

dr.priyankayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) Vaidyaratnam P S Varier Ayurveda College Kottakkal   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J329||Chronic sinusitis, unspecified. Ayurveda Condition: DUSHTAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: A.H.sutrasthana, Procedure details: 4 ml per nostril in two instillation for 7 days)
(1) Medicine Name: Anu thaila, Reference: Ashtangahridaya, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: not applicable, Procedure details: nasal spray made of selected drugs of Anuthaila is prepared. 2 sprays each is instilled in each nostril. )
(1) Medicine Name: nasal spray made of selected drugs of Anuthaila, Reference: not applicable, Route: Nasal, Dosage Form: Not Applicable, Dose: 0.26(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Participants fulfilling diagnostic criteria
2 Participants indicated for nasya
3 Participants of all gender in between age 18 and 60 years
4 Those who have willingness to participate in the study
 
 
ExclusionCriteria 
Details  1 Blood-stained nasal discharge
2 Nasal polyp
3 H/o polypectomy and sinus surgery within 3 months
4 Uncontrolled Diabetes Mellitus and Hypertension
5 Pregnant/ lactating women
6 History of hypersensitivity to the trial drug
7 Any other condition that may jeopardize the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Scale for scoring symptoms of Chronic sinusitis
2 Rhinosinusitis Disability Index15
3 Visual Analogue Scale for pain
4 Samyak nasya lakshana assessment proforma
5 Event Evaluation Scale
 		 0,7,14 and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
HPTLC GC Of nasal spray of selected drugs of anuthaila  6 months 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   15/07/2023 
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="0" 
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   A randomised controlled non inferiority trial is planned in chronic sinusitis to compare anuthaila nasya and nasal spray made of selected drugs of anuthaila. Chronic sinusitis is a kapha pradhana vyadhi that shows seasonal flare ups and requires frequent sodhana. Nasya with anuthaila is having notewothy excretory action but patient complaince is low. Nasal spray is prepared as a combination of distillate and kasaya of selected drugs of anuthaila. The safety is assesed by event evaluation scale and anterior rhinoscopy. An assessment of efficacy will be done using the Scale for scoring of symptoms of Chronic sinusitis, Rhinosinusitis Disability Index (RDI) and Visual Analogue scale (VAS) for pain.  
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