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CTRI Number  CTRI/2025/03/082548 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 14/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study on the effectiveness of kapithashtaka choorna vs nasal spray in reducing enlarged adenoids in children 
Scientific Title of Study   Efficacy of kapithashtaka choorna in comparison to nasomac-f nasal spray in kantha shaluka, adenoid enlargement in children - An open labelled randomized controlled clinical trial 
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 Jadhao Uday Bhaskar 
Designation  Post Graduate Scholar, Department of Kaumarabhritya 
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore, Karnataka 
Address  Department of Kaumarabhritya OPD No. 7,8,9,22,23 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Challegatta, Bangalore 560074, Karnataka, India

Bangalore
KARNATAKA
560074
India 
Phone  8275857200  
Fax    
Email  jadhaouday5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srilakshmi 
Designation  Associate Professor, Department of Kaumarabhritya 
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore, Karnataka 
Address  Dr Srilakshmi, Flat no. A207, Abhi Sai Santrupthi Sir M Visvesvaraya Nagara 8th block, Annapurneshwari Nagara, Bangalore 560091 Karnataka India

Bangalore
KARNATAKA
560091
India 
Phone  8971263454  
Fax    
Email  srilakshmi.srinivas17@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jadhao Uday Bhaskar 
Designation  Post Graduate Scholar, Department of Kaumarabhritya 
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore, Karnataka 
Address  Department of Kaumarabhritya OPD No. 7,8,9,22,23 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Challegatta, Bangalore 560074, Karnataka, India

Bangalore
KARNATAKA
560074
India 
Phone  8275857200  
Fax    
Email  jadhaouday5@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda, Bangalore-560074 Karnataka, India 
 
Primary Sponsor  
Name  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital Bangalore 
Address  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital, Anchepalya Bangalore-560074 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 
Dr Jadhao Uday Bhaskar  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore  Department of Kaumarabhritya OPD No. 7,8,9,22,23 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH17, Anchepalya, Chellegatta, Bangalore 560074, Karnataka, India. Bangalore KARNATAKA 560074 India
Bangalore
KARNATAKA 		 8275857200

jadhaouday5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital, Anchepalya, Kumbalgodu Post Mysore Road, Bengaluru-560074, Karnataka, India Phone: 9741562586 email ID: sdmcabh@gmail.com  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 ArmDrugClassical(1) Medicine Name: Kapithashtaka Choorna, Reference: Ashtanga Hridaya Chikitsasthana 9/110-113, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: 2 groups 3-6 years - 2.5g BID 7-10 years - 4.5g BID
2Comparator Arm (Non Ayurveda)-Nasomac-F Nasal Spray2 groups 3-6 years - 50mcg (1spray in each nostrils) BID - 28 days 7-10 years - 50mcg (1spray in each nostrils) BID - 28 days
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Children of age group 3-10 years of either sex who fulfills the diagnostic criteria.
2.Willing to participate under parental consent. 
 
ExclusionCriteria 
Details  1.Children below 3 years and above 10 years will be excluded.
2.Children suffering from nasal polyp, nasal bleeding will be excluded.
3.Children having anatomical anomalies like nasal septum deviation, craniofacial malformation including cleft lip, cleft palate, hypersensitivity to drugs.
4.Children with previous adenoidectomy cerebral palsy, genetic syndrome, ear discharge, tympanic membrane (TM) perforation, and congenital ear deformities.
5.Children suffering from other systemic illness will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relieving clinical features and significant improvement of Adenoid Enlargement with subjective symptomatic grading for mouth breathing, snoring, sleep disturbance and otological infection which will be assessed before treatment, 14th day, 28th day and 42nd day   42 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   29/03/2025 
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)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Efficacy of kapithashtaka choorna in comparison to nasomac-f nasal spray in kantha shaluka, adenoid enlargement in children - an open labelled randomized controlled clinical trial. Minimum 30 children attending outpatient department and inpatient department of Kaumarabhritya of Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital (SDMIAH), Bengaluru who are fulfilling the inclusion criteria and willing to participate in the study under the parental assent or consent will be recruited for study for a period of 42 days. 30 children will be randomly divided into 2 groups namely Group A (15 children) and Group B (15 children). Group A (Study group) will be administered with Kapithashtaka Choorna in a dose of 2.5g for 3-6 years and 4.5g for 7-10 years with Takra as anupana after food twice daily.

Group B (Control group) will be administered with Nasomac-F nasal spray in a dose of 50mcg for 3-6 years and 50mcg for 7-10 years 1 spray twice daily. Assessment will be done using Lateral X-ray of nasopharynx or nasal endoscopy. Statistical analysis will be done by considering the data of 0 (BT) 14 (monitoring) 28 (AT) and day 42 (follow up) by using suitable test.


 
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