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CTRI Number  CTRI/2025/06/089664 [Registered on: 27/06/2025] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of hypertrophied adenoids in children.  
Scientific Title of Study   Clinical study to evaluate the combined effect of apamarga kshara taila prathimarsha nasya and oral administration of kumarabharana rasa in the management of hypertrophied adenoids in children. 
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. Chandana Lakshmi 
Designation  PG Scholar 
Affiliation  Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan. 
Address  Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan. kaumarabhritya dept 2nd floor of college building

Hassan
KARNATAKA
573201
India 
Phone  9901709928  
Fax    
Email  pg22120@sdmcahhassan.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Vijaya laxmi mallannavar 
Designation  Associate professor  
Affiliation  Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan. 
Address  Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan.

Hassan
KARNATAKA
573201
India 
Phone  9480624829  
Fax    
Email  abtittu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Vijayalaxmi mallannavar 
Designation  Associate professor  
Affiliation  Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan. 
Address  Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan. kaumarabhritya dept 2nd floor of college building

Hassan
KARNATAKA
573201
India 
Phone  9480624829  
Fax    
Email  abtittu@gmail.com  
 
Source of Monetary or Material Support  
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan-573201 karnataka India  
 
Primary Sponsor  
Name  Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan 
Address  Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan 573201 karnataka Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan 573201 karnataka 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 
DrChandana Lakshmi  Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan.   Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan.department of kaumarabhritya opd 16
Hassan
KARNATAKA 
9901709928

pg22120@sdmcahhassan.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITEE SRI DHARMASTALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J352||Hypertrophy of adenoids. Ayurveda Condition: KANTHASALUKAH/TUNDIKERI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: astanga hridaya uttara tantra 21 st chapter, Procedure details: prathimarsha nasya with apamarga kshara taila 2 drops to each nostril twice daily mormimg & evening )
(1) Medicine Name: apamarga kshara taila, Reference: astangahridaya uttara tantra 21 chapter and afi, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 30 Days
2Intervention ArmDrugOther than Classical(1) Medicine Name: kumarabharana rasa, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: new drug not mentioned in any classical ayurvedic text
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  .Subject of age group 3-8 years of either sex who fulfill the diagnostic criteria
2.The subject whose parents are willing to participate their child in the study and ready to
sign the consent form
 
 
ExclusionCriteria 
Details  Subject associated with fever.
2.Subject associated with nasal polyp and nasal bleeding.
3.Subject with any other systemic illness.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduction in nasal obstruction,mouth breathing, snoring ,reduction in size of adenoids  0th day (BT) 15th day (DT) 30th day (AT) 15th day (FU) 
 
Secondary Outcome  
Outcome  TimePoints 
impact on health status
reduction in recurrent infection
improvement in sleep  
0th day (BT) 15th day (DT) 30th day (AT) 15th day (FU) 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   20/07/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [chandanalakshmi999@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2026?
    Response (Others) -  one year post to publication

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

   Respiratory diseases are the greatest cause of pediatric medical visits,  nasal obstruction is most common.1Adenoid hypertrophy(AH) is an obstructive condition due to increased size of adenoids2. Adenoids being a part of immune system and act as the first line of defence mechanism of aerodigestive tract3, they can get inflamed and enlarged by allergy of upper respiratory tract  recurrent attacks of  rhinitis , sinusitis or chronic tonsilitis4..

   Adenoid hypertrophy occupies the most among all diseases of the upper respiratory tract in paediatric, accounting for about 34.5% according to NCBI a systematic review and Metaanalysis5. 0-75% adenoids enlargement is diagnosed at 3-10 years. The symptoms of adenoid hypertrophy tend to occur more among young children, because of the increased frequency of upper respiratory tract infections and the small volume of the nasopharynx.  Even though  this condition is generally self-resolving due to age-related adenoid atrophy,  AH can lead to a series of serious complications including sleep-disordered breathing and sleep apnea which in children can lead to growth failure, and neurocognitive abnormalities such as low intelligence quotient, learning and behavioral problems, poor attention span,ear infections, temporary hearing loss and Pulmonary hypertension6.

    

   The treatment options available for  adenoid hypertrophy are antibiotics, antihistamines  , nasal steroidsand surgical management called adenoidectomy may result in postoperative complications such as immediate and late bleeding (0.7%)7 ,vomiting  ,difficulties in swallowing and pain .recurrence of adenoid tissue is 20% The  risk of adenoid re-growth is slightly more common in patients who undergo adenoidectomy at a young age8.The complications arising from the medical and surgical management makes us to find out the alternative line of management with no added adverse effect .

   In Ayurveda, adenoid enlargement can be well correlated with Kanthashaluka9owing to the marked similarities of the clinical presentations of hypertrophied adenoids like margarodha,kolavath granti10.As it is  an urdhwajatrugatavikara and nasya is widely adopted and effective treatment modalityfor the management11, in the present study pratimarshanasya is taken as choice of intervention . As the disease is kaphapradhana the drug of choice should have,katu rasa,ushnateekshna guna12hence apamargataila is selected for pratimarshanasya and kumarabharana tablet internally.

   As apamarga is having katutikta rasa ushnaveerya,shodana and ropana property, it is  taken as drug of choice and Kumarabharana Rasa is Anubhuta Yoga (formulation) which is very effective in management of chronic respiratory diseases especially in children as it is observed during the clinical practice13 .Hence in the present study an attempt is made to evaluate the combined effect of prathimarshanasya with apamargaksharatailaand kumarabharana tablet internally in hypertrophied adenoids

 
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