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CTRI Number  CTRI/2025/10/095868 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   To study the role of Homoeopathic Medicine in Chronic Sinusitis Among Age Group of 21 to 40 Years 
Scientific Title of Study   Effectiveness Of Individualization In Homoeopathic Management Of Chronic Sinusitis Among Age Group Of 21 To 40 Years An Experimental Non Controlled Study  
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 Rutuja Gangarde 
Designation  PG Student 
Affiliation  Dr G D Pol Foundation YMT Homoeopathic Medical College and PG Institute 
Address  Department of Organon of Medicine and Homoeopathic Philosophy DR G D Pol Foundation YMT Homoeopathic Medical College Hospital and PG Institute Institutional Area Sector 4 Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9175536034  
Fax    
Email  rutujagangarde26@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sampada Rawale 
Designation  Associate Professor 
Affiliation  Dr G D Pol Foundation YMT Homoeopathic Medical College and PG Institute 
Address  Department of Organon of Medicine and Homoeopathic Philosophy DR G D POL Foundation YMT Homoeopathic Medical College Hospital and PG Institute Institutional Area Sector 4 Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  8779602286  
Fax    
Email  sampadamasurkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chintan Mehta 
Designation  Associate Professor 
Affiliation  Dr G D Pol Foundation YMT Homoeopathic Medical College and PG Institute 
Address  Department of Homoeopathic Materia Medica Dr G D Pol Foundation YMT Homoeopathic Medical College and PG Institute Area Sector 4 Kharghar Navi Mumbai
Department of Homoeopathic Materia Medica Dr G D Pol Foundation YMT Homoeopathic Medical College and PG Institute Area Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India 
Phone  9869021226  
Fax    
Email  omcvm@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr G D Pol Foundation YMT Homoeopathic Medical College and PG Institute Hospital Institutional Area Sector 4 Kharghar Navi Mumbai Raigarh 410210 Maharashtra India  
 
Primary Sponsor  
Name  Dr Rutuja Gangarde 
Address  Dr G D Pol Foundation YMT Homoeopathic Medical College and PG Institute Hospital Institutional Area Sector 4 Kharghar Navi Mumbai 410210 
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 Rutuja Gangarde  Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital and PG Institute  OPD NO 3(Medicine) Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital and PG Institute Institutional Area Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA 
9175536034

rutujagangarde26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital and PG Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J328||Other chronic sinusitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Management With Respect to Individualization  According to the Requirement of the Patients Health Homoeopathic Medicine in the form of pills will be Prescribed during First day and Follow up after 15 Days or as and when Requirement of Patient 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Patients having maxillary and frontal sinusitis
2. Patients of all genders
3. Pre-diagnosed cases of chronic sinusitis
4. Patients aged between 21 and 40 years
5. Patient willing for written informed consent
 
 
ExclusionCriteria 
Details  1. Patients who have sinusitis with polyps.
2. Individuals who are suspected to be immunocompromised
3. Patient on another line of treatment for chronic sinusitis.
4. Patients with systemic comorbidities 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome Will be Assessed in Terms of
1 Improved (Current SNOT-22 – Previous SNOT-22) less than 8.9
2 Not Improved: (Current SNOT-22 – Previous SNOT-22) greater than 8.9

This Criteria Will be Assessed as per Score of SNOT 22 Scale 
1. Duration of study: Duration of study- 18 months.
2. Duration of each case: Each case will be studied for 6 months.
3. Duration of Follow up: Each case will be followed up at the interval of 15
days or earlier, if required.
4. Statistical outcome assessment will be done at the baseline, 3 months, 6
months.
 
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPLICABLE   NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/10/2025 
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  

Introduction:
Chronic sinusitis is classified in ICD-11 CM as diagnostic code CA0A.1.
Chronic sinusitis is a long-standing inflammation of the mucosal lining of the paranasal sinuses that persists for 12 weeks or more, usually due to infectious or allergic causes. It is characterized by nasal obstruction, facial pain or pressure, nasal discharge, post-nasal drip, and reduction or loss of smell. The disease significantly affects patients’ quality of life and productivity, particularly among adults aged 21 to 40 years.
Homoeopathy, based on the principle of Individualization, recognizes that no two persons are identical even when suffering from the same disease. Each patient’s remedy is selected according to the totality of symptoms on the physical, emotional, and intellectual planes. The individualized approach aims to correct the internal imbalance responsible for chronic sinus inflammation rather than providing only symptomatic relief.
Hence, this study is undertaken to evaluate the effectiveness of individualization in homoeopathic management of chronic sinusitis among adults aged 21 to 40 years.

Epidemiology
Chronic rhinosinusitis affects approximately 134 million Indians (about 1 in 8 people). Its prevalence in urban areas ranges from 5 to 15 percent, and it is more frequent in the productive age group of 21 to 40 years. The disease imposes a substantial socioeconomic and emotional burden and often requires repeated medical intervention.

Aims and Objectives:

Primary Objective:

To assess the effectiveness of individualization in homoeopathic management of chronic sinusitis.

Other Objectives:

To compare pre-treatment and post-treatment scores in cases of chronic sinusitis using the validated SNOT-22 (Sino-Nasal Outcome Test) scale.

To study the clinical presentation of chronic sinusitis.

To analyse and evaluate the characteristic symptoms observed during the process of individualization.

Materials and Methodology:

Type of study design: A Prospective Non-Controlled Experimental Study

Study setting: Patients of chronic sinusitis will be enrolled from the Out-Patient Department of the institution.

Study population: Clinically pre-diagnosed patients of chronic sinusitis.

Duration of study: 18 months.

Methods of selection of study subjects

Inclusion Criteria

 Pre-diagnosed cases of chronic sinusitis (maxillary and/or frontal).
Patients of all genders aged 21 – 40 years.
  Patients willing to give written informed consent.

Exclusion Criteria
Patients with sinusitis with polyps.
Individuals suspected to be immunocompromised.
  Patients on another line of treatment for chronic sinusitis.
  Patients with systemic comorbidities.
  Pregnant and lactating females.

Subject Withdrawal Criteria

Patients with irregular follow-ups.

Patients who withdraw consent from the study.

Patients developing exclusion criteria during the study.

Patients taking any other medication during the treatment period.

Method of Selection of Comparison or Control Group  Not Applicable.
Matching Criteria  Not Applicable.

Specification of Instruments & Measurements

Standardized Homoeopathic Case Record.

Pre-validated SNOT-22 Scale.

The scale will be operated by a researcher; operator and assessor will be different.

Outcome Assessment Criteria

Clinical Outcome
Reduction in intensity and frequency of sinus symptoms such as nasal obstruction, facial pain, and nasal discharge.
Overall improvement of the patient as a whole based on physical generals and mental state.

Statistical Outcome
Comparison of pre-treatment and post-treatment scores on SNOT-22 Scale.

Improved: (Current SNOT-22 – Previous SNOT-22) < – 8.9

Not Improved: (Current SNOT-22 – Previous SNOT-22) > – 8.9

Sample Size 40 patients.
Sampling Technique  Non-Probability Purposive Sampling.

Methods of Data Collection

      Clinically pre-diagnosed patients will be enrolled from OPD based on inclusion and exclusion criteria.

   Detailed case-taking will be done as per standardized Homoeopathic proforma.

  Similimum will be selected on the basis of totality of symptoms and individualization according to     Kent’s philosophy.

Posology (potency and repetition) will be decided as per susceptibility in each case.

Duration

Duration of study  18 months.

Duration of each case  6 months.

Duration of follow-up  Every 15 days or earlier if required.

Statistical assessment At baseline, 3 months and 6 months after initiation of treatment.

Plan for Statistical Analysis

Data will be compiled in MS Excel and analysed using SPSS software.

Descriptive statistics such as frequency (n), percentage , mean and standard deviation will be applied.

Normality will be checked using the Shapiro–Wilk or Kolmogorov–Smirnov test.

Intragroup comparisons for normally distributed data will be done using paired t-test; for non-parametric data, Wilcoxon signed-rank test will be used.

Chi-square test will be applied to categorical data.

Alpha error 5%, Beta error 20%, Power 80%; p < 0.05 will be considered statistically significant.





 
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