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CTRI Number  CTRI/2024/01/061779 [Registered on: 23/01/2024] Trial Registered Prospectively
Last Modified On: 08/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Are individualised homoeopathic medicines effective in treating chronic rhinosinusitis with nasal polyps?  
Scientific Title of Study   Effectiveness of individualised homoeopathic medicines in chronic rhinosinusitis with nasal polyposis - A prospective single arm quasi experimental study  
Trial Acronym  Not Applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya Babu 
Designation  Junior Resident 
Affiliation   
Address  Room number 8 Research OPD Ground floor Out patient Block Government Homoeopathic Medical College Hospital Karaparamba Kozhikode

Kozhikode
KERALA
673010
India 
Phone  9446479003  
Fax    
Email  divyababukooremkunnel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr THARA K 
Designation  PROFESSOR HEAD OF THE DEPARTMENT MATERIA MEDICA 
Affiliation  Government Homoeopathic Medical College Hospital Karaparamba Kozhikode 
Address  Government Homoeopathic Medical College Hospital Karaparamba Kozhikode

Kozhikode
KERALA
673010
India 
Phone  9745245755  
Fax    
Email  drthararaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Divya Babu 
Designation  Junior Resident 
Affiliation  Government Homoeopathic Medical College Hospital Karaparamba Kozhikode 
Address  Department of Materia medica Government Homoeopathic Medical College Hospital Karaparamba Kozhikode

Kozhikode
KERALA
673010
India 
Phone  9446479003  
Fax    
Email  divyababukooremkunnel@gmail.com  
 
Source of Monetary or Material Support  
Room number 8 Research OPD Ground floor Out patient Block Government Homoeopathic Medical College Hospital , Karaparamba P.O Kozhikode PIN : 673010  
 
Primary Sponsor  
Name  DR DIVYA BABU 
Address  Government Homoeopathic Medical College Hospital Kozhikode 
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 Divya Babu  Government Homoeopathic Medical College Hospital  OP no 8 Research OPD Ground floor Out Patient Block Department of Materia medica Government Homoeopathic Medical College Hospital Karaparamba P.O Kozhikode PIN :673010
Kozhikode
KERALA 		 9446479003

divyababukooremkunnel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Homoeopathic Medical College Hospital Kozhikode  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J330||Polyp of nasal cavity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine  Homoeopathic medicine of various potencies ranging from 6C to 50M mentioned in HPI administered orally according to principles of homoeopathy for 3 months 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 
1. Age group between 18-60 years of both gender
2. Cases fulfilling the working case definition
criteria 
 
ExclusionCriteria 
Details  1.Persons with cranio-facial deformities.
2.Benign or Malignant Tumor of Sino nasal mucosa.
3.Pregnant and Lactating Mothers.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome of the treatment will be assessed according to the changes in the Sino Nasal
Outcome Test -22 score and volume of nasal airflow during maximum inspiration recorded
using nasal peak inhalatory flow meter at baseline and end of 16 weeks.
 		 4 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Outcome of the treatment will be assessed according to the changes in volume of nasal airflow during maximum inspiration recorded using nasal peak inhalatory flow meter at baseline and end of 16 weeks.  4 months 
 
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 3 
Date of First Enrollment (India)   30/01/2024 
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   The final stage of the local expression of a chronic inflammatory disease of the sinonasal tract is represented by nasal polyp. The ailment is a unique kind of chronic rhinosinusitis known as chronic rhinosinusitis with polyps .Nasal polyps develop in individuals with persistent inflammation brought on by many various illnesses and the reasons why certain people develop unknown polyps still exist. Nasal polyp incidence ranges from 1 to 20 per 1000 people in the year population . This incidence declines after 60 years of age . In the normal population the prevalence is between 1 and 4 % in adults and 0.1 % in children . Nasal polyps are more common in males ( 2 - 4 ; 1 ). There is no racial predilection. 
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