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CTRI Number  CTRI/2024/12/078310 [Registered on: 18/12/2024] Trial Registered Prospectively
Last Modified On: 10/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homoeopathic treatment of sinus problems in adults 
Scientific Title of Study   A double-blind, randomized, placebo-controlled trial to evaluate the efficacy of individualized homoeopathic medicines in the treatment of chronic rhinosinusitis in adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1316-5029  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monalisa Khatun 
Designation  Postgraduate Trainee 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept of Materia Medica, OPD room no. PG2 (Materia Medica) and 7 (ENT), 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone    
Fax    
Email  monalisakhatun96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Saima Shamim 
Designation  Reader 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept of Materia Medica, OPD room no. PG2 (Materia Medica), 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  7059526218  
Fax    
Email  drsaima_7@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Saima Shamim 
Designation  Reader 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept of Materia Medica, OPD room no. PG2 (Materia Medica), 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  7059526218  
Fax    
Email  drsaima_7@yahoo.com  
 
Source of Monetary or Material Support  
D N De Homoeopathic Medical College and Hospital 12 Gobinda Khatick Road Kolkata 700046 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College and Hospital 
Address  12 Gobinda Khatick Road 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 Monalisa Khatun  D N De Homoeopathic Medical College and Hospital  Dept of Materia Medica OPD No PG2 and OPD No 7, 12 Gobinda Khatick Road, Kolkata 700046
Kolkata
WEST BENGAL 		 9002255982

monalisakhatun96@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of D N De 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: J329||Chronic sinusitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical-looking placebo plus concomitant care  This group will receive a placebo in conjunction with concomitant care. The placebo will have the same appearance as the active treatment. Each dose of the placebo will comprise 3-4 globules (number 40) of cane sugar, which will be moistened with rectified spirit and administered orally on a clean tongue while fasting; the dosage and frequency will be tailored to the individual needs of the participants. All materials will be sourced from a firm that adheres to Good Manufacturing Practice (GMP) standards. The follow-up period will last for three months. Both the active medications and placebos will be repackaged in identical glass containers, labeled with a code, the name of the medication, potency, and dispensed according to a random number list. Concomitant care measures include steam inhalation, meditation, yoga, avoidance of alcohol, tobacco and dusty environment. Dose: Individualized. Frequency: Individualized. Route of administration: per oral. Duration of therapy: 3 months. 
Intervention  Individualized homeopathic medicines in individualized dosage plus concomitant care  This group will be provided with homoeopathic remedies along with concomitant care. Individualized homoeopathic medicines will be administered in centesimal potencies, as deemed suitable for each specific case or condition. Each dose on the centesimal scale will comprise 3-4 globules (number 40) of cane sugar, which will be moistened with the prescribed remedy (preserved in 90% v/v ethanol) and taken orally on a clean tongue while in empty stomach. The dosage and frequency will be tailored to the individual needs of the patients. They will be instructed to avoid handling the globules and to refrain from eating, drinking, smoking, or brushing their teeth for 30 minutes after ingestion. Patients will be encouraged to dissolve the globules in their mouths rather than swallowing them whole. A single, individualized remedy will be prescribed during each consultation, considering the totality of presenting symptoms, detailed clinical history, constitutional characteristics, miasmatic expressions, and repertorization using HOMPATH® software, when necessary, with appropriate reference to Materia Medica and consensus among three homoeopaths. All remedies will be sourced from a firm that adheres to Good Manufacturing Practice (GMP) standards. Concomitant care measures include steam inhalation, meditation, yoga, avoidance of alcohol, tobacco and dusty environment. Dose: Individualized. Frequency: Individualized. Route of administration: per oral. Duration of therapy: 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients suffering from CRS for 12 weeks or more, who had not taken any treatment for the last 2 weeks, fulfilled the diagnostic criteria of AAO-HNS.
2. Age 18 to 65 years.
3. Patients ability to understand English, Hindi and/or Bengali.
4. Participants of either sex or transgender.  
 
ExclusionCriteria 
Details  1. Not willing to provide with written consent of voluntary participation.
2. Mild case 8 to 20 and severe case more than 50 of chronic rhinosinusitis according to SNOT 22 score.
3, Have DNS, swollen nasal turbinate, nasal polyp or nasal obstruction or any other structural abnormalities of nose and eyes.
4. Respiratory infections.
5. Patients with risk of developing bronchial asthma.
6. Suffering from uncontrolled systemic illness or life threatening infections.
7. Regular or excessive use of alcohol, tobacco, substance abuse and any other addiction.
8. Person under corticosteroid therapy.
9. Vulnerable population unconscious, non ambulatory, too sick for consultation, terminally ill or critically ill, mentally incompetent people.
10. Pregnant and puerperal women and lactating mother.
11. Self reported immune compromised state.
12. Already undergoing homoeopathic treatment within last 3 months for any other disease.
13. Simultaneous participation in any other trial. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Sino Nasal Outcome Test-22 questionnaire (SNOT 22)
 		 Baseline, and every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) questionnaire  Baseline, and every month, up to 3 months 
Detect the frequency of conventional treatment utilization.  Baseline, and every month, up to 3 months 
 
Target Sample Size
Modification(s)  		 Total Sample Size="105"
Sample Size from India="105" 
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/ Phase 3 
Date of First Enrollment (India)   01/01/2025 
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)  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 [monalisakhatun96@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
    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 - NIL
Brief Summary
Modification(s)  		 Chronic rhinosinusitis is a group of disorders that is characterized by inflammation of the mucosa of the nose and paranasal sinuses and present with of at least two of the following primary clinical symptoms: anosmia, hyposmia, facial discomfort or pressure, facial congestion or fullness, purulent nasal discharge, and nasal congestion or blockage. These symptoms must persist  for a minimum period of 12 weeks. Homoeopathy is a frequently used therapy to treat chronic rhinosinusitis; however, the research evidence is limited. This 3 months, double-blind, randomized, placebo-controlled trial is aimed at evaluating the efficacy of homoeopathic medicines in the treatment of chronic rhinosinusitis in 105 adults .The primary outcome is SNOT-22; the secondary outcomes are MYMOP-2 questionnaires and measure the frequency of conventional treatment utilization, all  measured at baseline, and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Result will be published in scientific journals.  
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