| CTRI Number |
CTRI/2025/08/093032 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see the effect of LM potency in Homoeopathy on people with long term sinus problems |
|
Scientific Title of Study
|
Effectiveness of LM potency in the Homoeopathic management of chronic sinusitis - A clinical 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 NEESHMA S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room no 403,3rd floor, college building, Department of Organon of Medicine and Homoeopathic Philosophy,Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari DIstrict
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9600646587 |
| Fax |
|
| Email |
neeshmasuku2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M MURUGAN |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room no 403,3rd floor, college building, Department of Organon of Medicine and Homoeopathic Philosophy,Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari DIstrict
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443343707 |
| Fax |
|
| Email |
drmmuruganhomoeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M MURUGAN |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital |
| Address |
Room no 403,3rd floor, college building, Department of Organon of Medicine and Homoeopathic Philosophy,Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari DIstrict
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443343707 |
| Fax |
|
| Email |
drmmuruganhomoeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamilnadu, 629161 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Research Funded by College |
| Address |
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamilnadu, 629161 |
| Type of Sponsor |
Private 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 NEESHMA S |
Sarada Krishna Homoeopathic Medical College |
Department of Organon of Medicine , OPD, IPD, Rural Health Centres, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari, Tamilnadu, 629161
Kanniyakumari
TAMIL NADU |
9600646587
neeshmasuku2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J324||Chronic pansinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator Agent |
This is a Single Arm Interventional Study , so there is no Comparator Agent is utilized |
| Intervention |
HOMOEOPATHIC TREATMENT WITH LM POTENCY |
Twenty pre- diagnosed cases of Chronic Sinusitis fulfilling the inclusion criteria will be purposively selected from the OPD, IPD, Rural Health Centers of Sarada Krishna Homoeopathic Medical College and Hospital.The cases will be recorded in the pre-structured case format of Sarada Krishna Homoeopathic Medical College.Prescription of LM potency based on individualized homoeopathic case taking.Starting potency and frequency will be determined by the nature of symptoms and clinical response.The patient will be followed for every two weeks and medicine will be of daily dose. Additionally, their progress is tracked and recorded using an assessment scale or questionnaire every three months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 18 to 50 years
Both sexes
Diagnostic criteria are mainly based on the clinical presentation
Improvement criteria are based on the symptom relief using chronic sinusitis assessment score
|
|
| ExclusionCriteria |
| Details |
Patient below 18 years and above 50 years
Pregnant and lactating women
Patient having other systemic illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of LM potency in the homoeopathic management of chronic sinusitis.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in symptoms of chronic sinusitis, as measured by the Chronic Sinusitis Assessment Score (CSAS).
Patients were assessed before and after treatment.
A significant reduction in CSAS scores indicated clinical improvement.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
sinusitis is a persistent inflammation of the paranasal sinuses, commonly
presenting with nasal obstruction, facial pain, headache, and postnasal drip.
Epidemiologically, chronic sinusitis affects around 134 million people in
India—more than diabetes or asthma—and is one of the most frequently treated
conditions with antibiotics. Despite LM potency being recognized for its gentle
and adaptable action in chronic diseases, there is limited clinical evidence
supporting its effectiveness when administered in a fixed daily dose. Most
existing studies emphasize individualized or varied dosing regimens, creating a
gap in reproducibility and consistency. This study aims to bridge that gap by
evaluating the impact of a standardized LM potency . The review of literature
highlights chronic sinusitis as a condition influenced by infectious agents,
allergens, structural abnormalities, and immune dysfunctions, often leading to
complications if not managed effectively. This study seeks to provide evidence
supporting the effectiveness of LM potency in the consistent and holistic
management of chronic sinusitis. |