| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rumakhatun5005@gmail.com].
- 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.
- 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. |