| CTRI Number |
CTRI/2025/11/096875 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Individualised Homoeopathic Medicine in Chronic Rhinosinusitis. |
|
Scientific Title of Study
|
Comparative Effectiveness of Individualised Homoeopathic medicine in Centesimal and 50 Millesimal Potency in the treatment of patients with Chronic Rhinosinusitis: An open label Prospective Randomised Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BANDI KUSUMAPRIYA |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD NO: 18, Department of HOMOEOPATHIC Materia Medica, National Institute of Homoeopathy, Block -GE, Sector 3, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
8309983943 |
| Fax |
|
| Email |
kusumapriyabandi1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SWAPAN PAUL |
| Designation |
Asscociate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD NO: 18, Department of HOMOEOPATHIC Materia Medica, National Institute of Homoeopathy, Block -GE, Sector 3, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SWAPAN PAUL |
| Designation |
Asscociate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD NO: 18, Department of HOMOEOPATHIC Materia Medica, National Institute of Homoeopathy, Block -GE, Sector 3, Salt Lake, Kolkata
Warangal
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Kolkata |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Sector 3, Salt lake, Kolkata 700106 |
| 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 BANDI KUSUMAPRIYA |
National Institute of Homoeopathy |
OPD NO: 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block -GE, Sector 3, Salt Lake, Kolkata
Kolkata
WEST BENGAL |
8309983943
kusumapriyabandi1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualised Homoeopathic Medicine in 50 Millesimal Potency. |
Medicine will be prescibed in 50 Millesimal potency according to Homoeopathic Principles regarding dose, potency, Repetition. Indicated Homoeopathic Medicine will be administered for a period of 4 months. Total duration of therapy is 4 months. Data will be recorded at baseline and 4 months for each individual patient. |
| Intervention |
Individualised Homoeopathic Medicine in Centesimal potency |
Medicine will be Prescribed in Centesimal potency according to Homoeopathic Principles regarding Dose, Potency, Repetition. Indicated Homoeopathic Medicine will be administered for a period of 4 months. Total duration of therapy is 4 months. Data will be recorded at baseline and 4 months for each Individual Patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants in age group between 18-60 years.
Participants belonging to all gender, all religion and all socio-economic status.
Participants having Chronic Rhinosinusitis, for 12 weeks or more, fulfilling the diagnostic criteria of AAO-HNS
Participants who can understand Bengali or Hindi or English; capable of filling the questionnaire.
Participants who are willing to participate in the study and giving informed written consent.
|
|
| ExclusionCriteria |
| Details |
Participants diagnosed with nasal polyps and the complications (mucous retention cyst, orbital cellulitis, meningitis, brain abscess etc.) of CRS.
Diagnosed cases of unstable psychiatric illness or some uncontrolled systemic diseases (like DM, Cancer and Thyroid diseases etc.), uncontrolled infections or any vital organ failure or immune-compromised patients.
Pregnant and lactating Women.
Substance abuse and or dependence or taking psychotropic drugs of modern medicine.
Participants who require surgical intervention for Chronic Rhinosinusitis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SNOT-22 score |
At baseline and 4 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EQ-5D-5L score, MONARCH Score. |
At baseline and 4 months. |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
15/11/2025 |
| 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
|
CHRONIC RHINOSINUSITIS ICD CODE-11-MMS DIAGNOSIS CODE CAOA.Z Chronic Rhinosinusitis (CRS) is a pervasive and debilitating inflammatory condition affecting the nose and paranasal sinuses. It is defined by symptomatic inflammation lasting a minimum of three months. The syndrome is clinically characterized by the persistent presence of at least two core symptoms for a minimum of 12 weeks, including nasal congestion or obstruction, anterior or posterior nasal discharge, an altered sense of smell (olfactory dysfunction), and facial pain or pressure. Patients who are suffering from Chronic Rhinosinusitis and registered in the OPD and IPD OF National Institute of Homoeopathy fulfilling the Inclusion and Exclusion criteria will be taken as sample of this Study. Dose and Frequency 0f the selected medicine as per the Homoeopathic Principle. Individualised medicine in centesimal and 50 Millesimal potency will be prescribed in accordance with randomised chart. Data of SNOT-22 , EQ-5D-5L and monarch scores will be assessed at baseline and after 4 months, to see the correlation, whether with the mean changes in SNOT-22 Score after using Individualised Homoeopathic Medicine in Centesimal and 50 Millesimal potency, will there also be a corresponding mean changes in EQ-5D-5L AND Monarch scores. |