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CTRI Number  CTRI/2024/03/064366 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic management of nasal blockage 
Scientific Title of Study   Role of individualized homoeopathic medicines in the treatment of nasal inferior turbinate hypertrophy in adolescents and adults: An open-label, single-arm, quasi-experimental study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1304-1077  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ruma Khatun 
Designation  Postgraduate Trainee 
Affiliation  D. N. De Homoeopathic College and Hospital 
Address  Dept. of Materia Medica, OPD room no. PG2 and ENT (room no. 7), 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  7980688227  
Fax    
Email  rumakhatun5005@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arpita Basu 
Designation  Professor 
Affiliation  D. N. De Homoeopathic College and Hospital 
Address  Dept. of Materia Medica, OPD room no. PG2 and ENT (room no. 7), 12, Gobinda khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9830273374  
Fax    
Email  drarpitasen@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arpita Basu 
Designation  Professor 
Affiliation  D. N. De Homoeopathic College and Hospital 
Address  Dept. of Materia Medica, OPD room no. PG2 and ENT (room no. 7), 12, Gobinda khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9830273374  
Fax    
Email  drarpitasen@gmail.com  
 
Source of Monetary or Material Support  
D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046 
 
Primary Sponsor  
Name  D.N.De Homoeopathic Medical College and Hospital 
Address  12, Gobinda Khatick Road, Tangra, Kolkata 700046 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruma Khatun  D. N. De Homoeopathic Medical College and Hospital  OPD room no. PG2 and ENT (room no. 7), 12, Gobinda Khatick Road, Tangra,Kolkata 700046
Kolkata
WEST BENGAL 
7980688227

rumakhatun5005@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J343||Hypertrophy of nasal turbinates,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homoeopathic medicines in centesimal potencies (CH) with concomitant care  Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Provision will be kept to change the medicines and potencies and adjust the dosage in subsequent visits whenever required following the principles of classical homoeopathy. All the enrolled patients will receive advice on hot vapor inhalation, nasal wash, and avoidance of dust exposure. Duration of therapy: 3 months. 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients suffering from nasal ITH (ICD11-Code CA0E).
2. Patients aged between 12 and 65 years.
3. Patients of either sex or transgender.  
 
ExclusionCriteria 
Details  1.Not providing written informed assent and/or consent voluntarily.
2. Patients having nasal obstruction unrelated to inferior turbinate hypertrophy, such as
symptomatic DNS, nasal polyps or tumors of nose.
3. Diagnosed cases of unstable mental or psychiatric illness or other systemic illness or
life-threatening illness affecting quality of life or any organ failure.
4. Vulnerable population: Unconscious, non-ambulatory, too sick for consultation,
differently abled, terminally ill or critically ill patients, and mentally incompetent
people.
5. Tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance
abuse and/or dependence (TAPS tool).
6. Self-reported immune-compromised state.
7. Already undergoing homoeopathic treatment for chronic disease.
8. Simultaneous participation in any other clinical trials. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NOSE score  Baseline, every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Sino Nasal Outcome Test-22 (SNOT-22)  Baseline, every month, up to 3 months 
Measure Yourself Medical Outcome Profile version2 (MYMOP-2) questionnaire  Baseline, every month, up to 3 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 
Date of First Enrollment (India)   01/04/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rumakhatun5005@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Nasal turbinate hypertrophy is Hypertrophy (enlargement) of nasal turbinates. Inferior turbinate hypertrophy, a condition where the tissue on the lateral (outside) walls of the nose are too large, causing nasal obstruction. While the worldwide prevalence of inferior turbinate hypertrophy is unknown, a large study by Clark et al, of over 1900 patients with sinonasal complaints revealed that 72% suffered from hypertrophied turbinates. However, this narrowing of the nasal cavity affects the physiological functions of the nasal mucosa, causing problems such as mouth breathing, dry oropharynx, nasal talking, sleep disorders, snoring, nasal congestion, stuffy nose when lying down, and secretions Nasal congestion may affect general health also causes irritability, fatigue, decreased quality of life. The treatment of inferior turbinate hypertrophy has been actively debated for over a century. The main goal of treatment is to minimize the symptoms and extent of hypertrophy of ITH. Although not life-threatening, chronic nasal obstruction significantly impairs patient’s quality of life affecting their daily social and working activities. Though the use of homoeopathic medicines is extensive globally to treat the condition, Research on nasal ITH in homoeopathic treatment limited. There is a notable research gap in understanding the effect and mechanism of homoeopathic intervention for nasal ITH. This provides the basis for to conduct an open-label, single-arm trial on 50 participants suffering from nasal ITH  in adolescents and adults using individualized homoeopathic medicines (IHMs) in outpatient departments(OPD) especially ENT and PG2 of D.N.De Homoeopathic Medical College and Hospital , Govt. of WB; 12, Gobindo Khatick Road, Tangra, Kolkata, WB 700046. Primary outcome will be measured by  using Nasal Obstruction Symptom Evaluation (NOSE) score; Sino Nasal Outcome Test-22(SNOT-22),  Measure Yourself Medical Outcome Profile version2 (MYMOP-2) questionnaire will be the secondary outcome. All the outcomes will be measured every month up to 3 months. Pre-post changes will be measured using appropriate statistical tests. Results will be published in scientific journals.

 
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