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CTRI Number  CTRI/2025/03/081796 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 02/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Screening 
Study Design  Other 
Public Title of Study   A clinical trial to study the effects of Rasnopakulyadi Kashaya and Rajanyadi churna in adenoid hypertrophy among children in the age group of 4 -12 years 
Scientific Title of Study   Combined effect of Rasnopakulyadi Kashaya and Rajanyadi churna in adenoid hypertrophy in the age group of 4-12 years  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANEESHA FATHIMA S 
Designation  PG SCHOLAR 
Affiliation  Government Ayurveda college hospital, pariyaram p. o, Kannur, 670503 
Address  Room no. 8, Shalakyatantra OPD, Government ayurveda college, Pariyaram P. O, kannur

Kannur
KERALA
670503
India 
Phone  8075876759  
Fax    
Email  aneeshafathima99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ambili k 
Designation  Associate professor, Shalakyatantra department, government ayurveda college, kannur. 
Affiliation  Government Ayurveda college hospital, pariyaram p. o, Kannur, 670503 
Address  Room no. 8, Shalakyatantra OPD, Government ayurveda college, Pariyaram P. O, kannur

Kannur
KERALA
670503
India 
Phone  9446028794  
Fax    
Email  amlikavinal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aneesha Fathima. S 
Designation  Pg Scholar, Government ayurveda college, pariyaram p. o, kannur, 670503 
Affiliation  Government Ayurveda college hospital, pariyaram p. o, Kannur,670503 
Address  Room no. 8, Shalakyatantra OPD, Government ayurveda college, Pariyaram P. O, kannur

Kannur
KERALA
670503
India 
Phone  8075876759  
Fax    
Email  aneeshafathima99@gmail.com  
 
Source of Monetary or Material Support  
Government ayurveda college, pariyaram p. o, Kannur, 670503 
 
Primary Sponsor  
Name  Government ayurveda college pariyaram p O kannur  
Address  Room no. 8, Shalakyatantra OPD, Government ayurveda college, pariyaram p. o, kaanur 
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 Aneesha Fathima S  Hospital   Room no. 8, Shalakyatantra opd, government Ayurveda college, pariyaram p.o, kannur
Kannur
KERALA 		 8075876759

aneeshafathima99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government ayurveda college, pariyaram p. o, kannur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: KANTHAGATAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Rasnopakulyadi kashayam, Reference: Arogya kalpa drumam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sita), Additional Information: Nil
(2) Medicine Name: Rajanyadi Choorna , Reference: Ashtanga hridaya , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu, ghrita), Additional Information: Nil
2Intervention ArmDrug-
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Participants in the age group of 4-12 years irrespective of gender.
Participants diagnosed with adenoid hypertrophy within 1 month by X - ray, CT or Diagnostic Nasal Endoscopy (DNE).
Participants with at least any one of the symptoms of adenoid hypertrophy such as,
Mouth breathing
Snoring
Sleep apnea (grade 1 and 2)
Nasal obstruction
Participants who are willing to give informed assent and parents’s consent.  
 
ExclusionCriteria 
Details  Participants suffering from other systemic illness
Participants who underwent conservative management for adenoids during the last 3 months.
Participants with complications of adenoid hypertrophy like otitis media, chest infection.
Children with body temperature above 99 degree Fahrenheit.
Participants with any other local or systemic illness other than grade 1 and grade2 tonsillar hypertrophy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mouth breathing
Snoring
Sleep apnea
Nasal obstruction  		 1year  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable  
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   01/04/2025 
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="0"
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  

The adenoid is a mass of lymphoid tissue located in the nasopharynx, responsible for producing antibodies. However, adenoid hypertrophy, a common condition where the adenoid becomes enlarged, can lead to nasal obstruction, resulting in sleep disorders such as snoring and sleep apnea. This, in turn, can cause educational and social problems. Chronic nasal obstruction and mouth breathing can also lead to adenoid facies, characterized by an elongated face, crowded teeth, and a pinched nose. If left untreated, complications such as middle ear infections, glue ear infections, and chest infections may occur. Fortunately, management options are available, including breathing exercises, decongestant nasal drops, steroid nasal spray, antihistamines, and in severe cases, adenoidectomy, the surgical removal of the adenoid.
 
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