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CTRI Number  CTRI/2022/12/048137 [Registered on: 15/12/2022] Trial Registered Prospectively
Last Modified On: 14/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Baladi tail nasya and Shigru tail nasya in kaphaja pratishyaya  
Scientific Title of Study   Randomized comparative clinical study of Baladi tail nasya and Shigru tail nasya in kaphaja pratishyaya w.s.r.chronic simple rhinitis  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dravid Kumar Rajesh Singh  
Designation  PG scholar  
Affiliation  Maharashtra University of health sciences nashik 
Address  Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department OPD no 11 kodoli dist Kolhapur
Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department OPD no 11 kodoli
Kolhapur
MAHARASHTRA
416114
India 
Phone  7738885883  
Fax    
Email  dravidsingh6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandrashekhar Mule 
Designation  PG Guide Professor and HOD shalakyatantra department  
Affiliation  Maharashtra University of health sciences nashik  
Address  Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department OPD no 11 kodoli dist Kolhapur
Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department OPD no 11 kodoli
Kolhapur
MAHARASHTRA
416114
India 
Phone  9175800710  
Fax    
Email  drcnm05@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandrashekhar Mule 
Designation  PG Guide Professor and HOD shalakyatantra department  
Affiliation  Maharashtra University of health sciences nashik  
Address  Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department OPD no 11 kodoli dist Kolhapur
Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department OPD no 11 kodoli
Kolhapur
MAHARASHTRA
416114
India 
Phone  9175800710  
Fax    
Email  drcnm05@gmail.com  
 
Source of Monetary or Material Support  
Yashwant Ayurvedic medical College PGT and RC kodoli dist Kolhapur Maharashtra  
 
Primary Sponsor  
Name  Dr Dravid Kumar Rajesh Singh  
Address  Yashwant Ayurvedic hospital kodoli kolhapur  
Type of Sponsor  Other [Self] 
 
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 Dravid Kumar Rajesh Singh   Yashwant Ayurvedic medical College kodoli  Yashwant Ayurvedic medical College PGT and RC kodoli shalakyatantra department OPD no 11 kodoli dist Kolhapur
Kolhapur
MAHARASHTRA 		 7738885883

dravidsingh6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: Ayurveda ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Shushrut uttar sthan 24/32, Procedure details: Baladi tail nasya and Shigru tail nasya 8 bindu (4-4bindu in each nostrils )once a day in morning for 7days )
(1) Medicine Name: Baladi tail, Reference: Shigru tail, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient between age 18to 60yr. Patient having signs and symptoms of kaphaja pratishyaya like nasa strava,kandu, headache 
 
ExclusionCriteria 
Details  Patient with other systemic diseases like known case of HTN ,DM,Asthma ,TB. Patient other than kaphaja pratishyaya like allergic Rhinitis and other atrophic Rhinitis and other nasal disorder like nasal polyps. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Decrease itching sensation, decrease post Nasal discharge,turbinate hypertrophy   Decrease itching sensation, decrease post Nasal discharge in 2weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Decrease nasal discharge decrease itching ,nasal mucosa   18 months  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   18/12/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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 Randomised comparative clinical study of Baladi tail nasya and Shigru tail nasya in kaphaja pratishyaya w.s.r to chronic simple rhinitis.study will be carried in OPD of shalakyatantra department of Yashwant Ayurvedic medical College and hospital kodoli.The observation would be drawn on the basis of symptoms after treatment given. 
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