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CTRI Number  CTRI/2025/02/080727 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 06/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Homoeopathic Treatment of Nasal Polyp 
Scientific Title of Study   A Comparative clinical study on the usefullness of Individualized homoeopathic medicine v/s Teucrium Marum Verum in the management of Nasal Polyp 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Bharti 
Designation  Postgraduate trainee 
Affiliation  State National Homoeopathic Medical College and Hospital, Viraj khand -1, Gomti Nagar, Lucknow  
Address  Department of Homoeopathic Materia Medica State National Homoeopathic Medical College and Hospital, Viraj khand -1,Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  7388974789  
Fax    
Email  poojabharti102@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shashi Arya 
Designation  Lecturer  
Affiliation  State National Homoeopathic Medical College and Hospital, Viraj khand -1 , Gomti Nagar, Lucknow  
Address  Department of Organon of Medicine, State National Homoeopathic Medical College and Hospital, Viraj khand -1, Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  9450417584  
Fax    
Email  drshashiarya2105@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shashi Arya 
Designation  Lecturer  
Affiliation  State National Homoeopathic Medical College and Hospital, Viraj khand -1 , Gomti Nagar, Lucknow  
Address  Department of Organon of Medicine, State National Homoeopathic Medical College and Hospital, Viraj khand -1, Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  9450417584  
Fax    
Email  drshashiarya2105@gmail.com  
 
Source of Monetary or Material Support  
State National Homoeopathic Medical College and Hospital, Viraj khand- 1, Gomti Nagar , Lucknow  
 
Primary Sponsor  
Name  Pooja Bharti  
Address  Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, Viraj khand -1, Gomti Nagar, Lucknow , Uttar Pradesh -226010 
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 Pooja Bharti  State National Homoepathic Medical College and Hospital  OPD NO-7, Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, Viraj khand-1, Gomti Nagar Lucknow-226010
Lucknow
UTTAR PRADESH 
7388974789

poojabharti102@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethical Committee State National Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J339||Nasal polyp, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine  Intervention is planned as administering individualized homoeopathic medicine to a group of 30 patients suffering from Nasal Polyp after detailed case taking and repertorization. Individualized Homoeopathic medicine will be given in varying potencies of centesimal scale depending upon the susceptibility of the patient. Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine (preserved in 90% v/v ethanol) to be taken orally on empty. Dosage and repetition will depend upon the individual requirement of the case. 
Comparator Agent  Teucrium Marum verum  Another group of 30 patient suffering from Nasal polyp will be administered Teucrium marum verum. The dose and repetition will depend upon the individualized requirement of the case 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Both male and female will be included.
2.Participants diagnosed with nasal polyp
3.Age group of 16 -45years suffering from nasal polyp will be included
4.Participants who will be ready to give consent and assent.
 
 
ExclusionCriteria 
Details  1.Participants on other medication .
2.Participants with other upper respiratory tract infections (laryngitis, pharyngitis, diphtheria, etc.)
3.Pregnant and lactating female.
4.Uncontrolled systemic or psychiatric illness .
5.Participants with other respiratory infections (chronic bronchitis, bronchial Asthma, cystic fibrosis).

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the changes in scoring in before and after treatment using SNOT 20 in patients with nasal polyp at baseline and after 6 months of treatment to compare the effectiveness of Teucrium Marum Verum and Individualized Homoeopathic medicines  12 weeks, 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the changes in size of nasal polyp using Xray-PNS at baseline and every 3 month of treatment  12weeks, 24 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/02/2025 
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 - NO
Brief Summary  

Nasal polyps are a manifestation of chronic rhinosinusitis with nasal polyps (CRSwNP), which is a chronic inflammatory condition affecting the sinus and nasal cavities. These polyps are often the result of long-term inflammation, frequently linked to conditions like chronic rhinitis, asthma, and allergies. They are common in adults, particularly those aged 40-60, and more prevalent in males. Symptoms include nasal congestion, loss of smell, chronic runny nose, and sometimes facial pain or headaches.

The exact cause of nasal polyps remains unknown, but it is linked to chronic inflammation. The condition can significantly affect a person’s quality of life and impose substantial financial costs due to medical expenses and lost productivity. Treatment typically involves a combination of medical management (such as antihistamines and steroids) and surgery for severe cases.

Homeopathic treatments, including Teucrium marum verum, have shown some promise in treating nasal polyps, although further research is needed to assess their efficacy fully. The study outlined aims to evaluate the comparative efficacy of individualized homeopathic treatment versus Teucrium marum verum in managing nasal polyps, using tools like the SNOT-20 questionnaire to measure symptom severity and patient well-being.

 
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