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CTRI Number  CTRI/2022/06/042996 [Registered on: 03/06/2022] Trial Registered Prospectively
Last Modified On: 31/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between effect of bala tail and tila tail nasya,pichu,pana in nasal obstruction(nasanaha) 
Scientific Title of Study   Comparative Clinical Evaluation of Bala Tail and Tila Tail Nasya,Pichu and Pana in Nasanaha 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Monika Mishra 
Designation  Pg student 
Affiliation  Patanjali bhartiya ayurvigyan avum anusandhan sansthan 
Address  Opd number 3,patanjali bhartiya ayurvigyan avum anushadhan sansthan haridwar ,249405

Hardwar
UTTARANCHAL
249405
India 
Phone  7248520330  
Fax    
Email  Mmonika851@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr preeti pahwa 
Designation  M.S (shalakya)/Associate professor 
Affiliation  Patanjali bhartiya ayurvigyan evum anusandhan sansthan 
Address  Patanjali bhartiya ayurvigyan evum anusandhan sansthan haridwar

Hardwar
UTTARANCHAL
249405
India 
Phone  9953117417  
Fax    
Email  drpreeti25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr preeti pahwa 
Designation  M.S (shalakya)/Associate professor 
Affiliation  Patanjali bhartiya ayurvigyan evum anusandhan sansthan 
Address  Patanjali bhartiya ayurvigyan evum anusandhan sansthan haridwar

Hardwar
UTTARANCHAL
249405
India 
Phone  9953117417  
Fax    
Email  drpreeti25@gmail.com  
 
Source of Monetary or Material Support  
Pata jali bhartiya ayurvigyan avum anusandhan sansthan 
 
Primary Sponsor  
Name  Patanjali ayurvedic hospital 
Address  Patanjali bhartiya ayurvigyan avum anusandhan sansthan haridwar 249405 
Type of Sponsor  Research institution and hospital 
 
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 monika mishra  Patanjali ayurveda hospital  Opd number 3 patanjali ayurved hospital,pata jali bharitya ayurvigyan avum anusandhan sansthan haridwar
Hardwar
UTTARANCHAL 		 7248520330

Mmonika851@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Patanjali ayurveda college ethical committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: NASAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: ashtang hridya sutra sthana 20/1, Procedure details: 8 drops of bala tail will be given as nasyya to patient in morning then pichu or nasal packing will be done with same oil)
(1) Medicine Name: bala tail, Reference: ashtang hridya chikitsa sthana21/72, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 9 Days
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: ashtang hridya sutra 20/1, Procedure details: 8 drops of tila tail will be given as nasyya to patient in morning then pichu or nasal packing will be done with same oil)
(1) Medicine Name: tila tail, Reference: sushruta sutra sthana 45/112, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 9 Days
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients suffering with clinical features of nasanaha (nasal obstruction)
2. Age group between 15 to 60 years
3.Patient having atleast 1-2 associated complaints e.g- headache, nasal discharge ,discomfort in nose, congested nasal mucosa and turbinates and reduced perception of smell
4. Patients yogya for nasya and pichu karma  
 
ExclusionCriteria 
Details  1. Age group below 15 & above 60 years
2 .patients with any other specific reason of nasal obstruction e.g nasal polyp, adenoids hypertrophy, tumours, carcinoma, foreign body, trauma ,any sinonasal surgeries, epistaxis etc.
3 .patients suffering with acute rhinitis or sinusitis.
4. patients suffering with COPD,or any other severe systemic
5.pregnant women and lactating mother 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Subjective Parameter-Grading will be done considering signs & symptoms of nasanaha..
 		 For subjective parameter 1st and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Objective parameter..x ray pns, anterior rhinoscopy  For objective parameter on 1 and 30 thday of trial 
 
Target Sample Size
Modification(s)  		 Total Sample Size="40"
Sample Size from India="40" 
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 1/ Phase 2 
Date of First Enrollment (India)   13/06/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not 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 a randomized, open-labeled, parallel-group, clinical trial, to compare and evaluate effect of bala tail and tila tail nasya pichu and pana in nasanaha..
Patients suffering with symptoms of nasanaha attending the OPD/IPD of SHALAKYA TANTRA department of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar will be selected randomly for this clinical study irrespective of sex, religion, occupation etc. A detailed Performa will be prepared on basis of Ayurvedic text and allied sciences. The patient fulfilling the inclusion and exclusion criteria will be registered on this Performa and scoring of different clinical features will be done on the assessment criteria.
 
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