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CTRI Number  CTRI/2024/07/070747 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 01/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   Combined effect of sunthyady ghritha nasal drops and vyoshadi vataka internally with honey in reducing signs and symptoms of allergic rhinitis 
Scientific Title of Study   Combined effect of sunthyadi ghritha prathimarsha nasya and vyoshadi vataka internally with honey in allergic 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  Anoopa P P 
Designation  Pg scholar 
Affiliation  Government ayurveda college kannur pariyaram 
Address  Department of shalakyatantra secondnd floor A block Government ayurveda college kannur pariyaram PIN 670503

Kannur
KERALA
670503
India 
Phone  8281475923  
Fax    
Email  anoopapp101@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ambili K 
Designation  Associate professor department of shalakyatantra 
Affiliation  Government ayurveda college kannur pariyaram 
Address  Room number 8 Department of shalakyatantra Government ayurveda college kannur pariyaram PIN 670503

Kannur
KERALA
670503
India 
Phone  9446028794  
Fax    
Email  amlikavinal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anoopa P P 
Designation  Pg scholar 
Affiliation  Government ayurveda college kannur pariyaram 
Address  Room number 8 Department of shalakyatantra Government ayurveda college kannur pariyaram PIN 670503

Kannur
KERALA
670503
India 
Phone  8281475923  
Fax    
Email  anoopapp101@gmail.com  
 
Source of Monetary or Material Support  
Government ayurveda college kannur pariyaram op no 8 department of shalakyatantra pin 670503 
 
Primary Sponsor  
Name  Anoopa P P 
Address  Government ayurveda college kannur pariyaram PIN 670503 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NA   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Anoopa P P  Government ayurveda college kannur pariyaram  Government ayurveda college kannur pariyaram op no 8 department of shalakyatantra Ground floor pin 670503
Kannur
KERALA 
8281475923

anoopapp101@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee government ayurveda college kannur pariyaram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: KSHAVATHUH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Ashtangahridaya, Procedure details: Procedure Reference: ASHTANGAHRIDHAYAM, Procedure details: Participants will be given with sunthyadi ghritha in dropper bottle for nasal administration. Methods of administration will be explained & demonstrated to the participant on the first day. The research participant is made to lie straight on his back with slight lowering of head, extending arms and legs. The ghritha is made luke warm. Taken in sterile dropper bottle and will be instilled 0.5ml in to each nostril, keeping the other one closed Inhale the ghritha and spit if it reaches the throat ) (1) Medicine Name: SUNTHYADI GHRITHA, Reference: CHAKRADATTA, Route: Nasal, Dosage Form: Ghrita, Dose: 0.5(ml), Frequency: od, Duration: 21 Days)
(1) Medicine Name: Sunthyadi ghritha, Reference: Chakradatta, Route: Nasal, Dosage Form: Ghrita, Dose: 0.5(ml), Frequency: od, Duration: 21 Days
2Intervention ArmDrugClassical(1) Medicine Name: Vyoshadi vataka, Reference: Ashtangahridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients diagnosed with allergic rhinitis
Patients of age group 15-45 years
Participants who are willing to give written informed consent and assent
 
 
ExclusionCriteria 
Details  Participants with existing nasal polyp tumors DNS severe dyspnea and sinusitis
Known cases of bronchial asthma cardiovascular diseases diabetic mellitus carcinoma AIDS
Known cases of bleeding disorders
Infective nasal disorders persisting even after 6 month
Participants who are already undergoing treatment for any allergic diseases
Pregnant and lactating women
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Total Nasal Symptom Score (TNSS)   37 DAYS  
 
Secondary Outcome  
Outcome  TimePoints 
AEC(Absolute Eosinophil Count)
Serum IgE  
37 DAYS 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   01/08/2024 
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)   Not Yet Recruiting 
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  

Allergic rhinitis is an IgE mediated immunologic response of nasal mucosa to airborne allergens and is  characterized by watery nasal discharge, nasal obstruction, sneezing and itching in the nose. Repeated  attack and improper management of the disease lead to many complications like eczema, nasal polyps,  otitis media, asthma, conjunctivitis, sinusitis, migraine etc. Living with chronic allergies can lead to  reduced quality of life and may affect one’s daily activities. Currently, the global prevalence of allergic  rhinitis is approximately 10% to 30% in adults and 40% in children. Approximately 22% of adolescents  currently suffer from allergic rhinitis in India. In Modern medical system, a wide range of intranasal  corticosteroids, antihistamines, leukotriene receptor and decongestants are available. But these drugs give  only symptomatic relief and also are not devoid of adverse effects. So we need such a treatment modality  which has maximum effect and having no complications. The clinical features of Allergic rhinitis shows  similarity with Kshavathu, which is mentioned as a nasaroga in Ayurveda classics. Sunthyadi ghritha nasya is mentioned in Chakradatta in the context of Nasarogadhikara. It includes sundi, kana, kushta,  bilva and draksha. Vyoshadi vataka is an ayurvedic classical formulation mentioned in nasaroga  pratisheda in ashtanga hridaya uttarasthana. Hence this study is designed to find out the combined  effect of sunthyadi ghritha prathimarsha nasya and vyoshadi vataka with honey internally in the  management of allergic rhinitis. Aim of the study is to assess the combined effect of ayurvedic management through prathimarsha nasya with sunthyadi ghritha and vyoshadi vataka with honey internally in allergic rhinitis. This study will be  conducted as a pre and post interventional study in op setting of Government Ayurveda College Kannur.  The study population will be selected on the basis of inclusion and exclusion criteria. Participant will be  given sunthyadi ghritha prathimarsha nasya (0.5ml) and vyoshadi vataka 6gm twice daily internally with  honey for duration 21 days. The follow up will be on 37th day. Assessment will be done using grading of  Total Nasal Symptom Score, absolute eosinophil count(AEC), immunoglobulin E (IgE). Result will be  statically analysed by paired t test and wilcoxon signed rank test. 


 
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