| CTRI Number |
CTRI/2024/08/072622 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
chronic sinusitis and homoeoepathic treatment |
|
Scientific Title of Study
|
Effects of individualized homoeopathic medicine on quality of life of patients with chronic sinusitis using SNOT22 – An experimental control 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 Vijayraje alias Satish Santram Karnik |
| Designation |
Associate Professor |
| Affiliation |
SJPES HMC and hospital Kolhapur |
| Address |
Room no 1, OPD and Department of Practice of medicine, SJPESs Homoeopathic Medical College and Hospital, Tararani chowk kolhapur
Maharashtra
416003
India
Kolhapur MAHARASHTRA 416003 India |
| Phone |
9822333668 |
| Fax |
02312668810 |
| Email |
vraje.1987@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sujata Kamire |
| Designation |
Professor |
| Affiliation |
SJPESs HMC Kolhapur |
| Address |
Room no 1, OPD and Department of Practice of medicine, SJPESs Homoeopathic Medical College and Hospital, Tararani chowk kolhapur
Maharashtra
416003
India
Kolhapur MAHARASHTRA 416003 India |
| Phone |
9823195866 |
| Fax |
02312652480 |
| Email |
sujatakamire@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sujata Kamire |
| Designation |
Professor |
| Affiliation |
SJPES HMC and hospital Kolhapur |
| Address |
Room no 1, OPD and Department of Practice of medicine, SJPESs Homoeopathic Medical College and Hospital, Tararani chowk kolhapur
Maharashtra
416003
India
Kolhapur MAHARASHTRA 416003 India |
| Phone |
9823195866 |
| Fax |
02312652480 |
| Email |
sujatakamire@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room no 1, OPD and Department of Practice of medicine, SJPESs Homoeopathic Medical College and Hospital, Tararani chowk kolhapur
Maharashtra
416003
India |
|
|
Primary Sponsor
|
| Name |
Dr Vijayraje alias Satish Santram Karnik |
| Address |
Room no 1, OPD and Department of Practice of medicine, SJPESs Homoeopathic Medical College and Hospital, Tararani chowk kolhapur
Maharashtra
416003
India |
| Type of Sponsor |
Other [self sponsored research] |
|
|
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 Vijayraje alias Satish Santram Karnik |
SJPESs homoeopathic medical college, tararani chowk kolhapur |
Room no 1, OPD and Department of Practice of medicine, SJPESs Homoeopathic Medical College and Hospital, Tararani chowk kolhapur
Maharashtra
416003
India Kolhapur MAHARASHTRA |
9822333668 02312652480 vraje.1987@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of SJPES homoeopathic medical college kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J32||Chronic sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine on quality of life of patients with chronic sinusitis using SNOT22 |
Dose is selected as per the patients susceptibility, Frequency of follow up is for 15-20 days, Route of administration is oral route and duration of treatment is 6 months till the date of improvement. follow up at the intervals of 15-20 days. Total duration of study is 18 months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients above 18 years of age
2.Patients from various socio-economic status & all the sexes will be considered for study
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from complications of chronic sinusitis
2. Pregnant and lactating females
3. Patients who are suspected Immuno compromised
4. Patient suffering from Malignancy
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To study the change in clinical features of Chronic Sinusitis before and after treatment using SNOT-22.
2) To study the therapeutics of Chronic Sinusitis. |
Duration of study – 18 months
Duration of each case – Each case will be studied for up to 7 days or till remission occurs whichever is earlier.
Duration of followup each case – each case will be followed up every month or whenever required
whole results of outcome will be explained at the end of 18 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.As per the work done on psychometric & clinometric validity of 22-Item (SINO NASAL OUTCOME TEST) or SNOT-22; SNOT-22 will be taken as a reliable scoring chart.
The SNOT-20 does have an importance rating. Patients will be asked to indicate the 5 items that are most important to them & that they expect to improve with treatment.
2.The possible range of SNOT-22 scores is 0 to 5, with a higher score indicating a greater rhino sinusitis-related health burden.
3.The impact of treatment is measured by calculating the difference between SNOT-22 scores before & after treatment.
4.Separate pre-treatment, post treatment, & change scores can be calculated for the items selected at the initial visit as being most important.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
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)
|
30/08/2024 |
| 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) |
Not Applicable |
Publication Details
Modification(s)
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic rhinosinusitis (CRS) is a common disorder, with up to an estimated 134 million Indian sufferers, and having significant impact on quality of life (QOL) and health costs. Chronic sinusitis is characterized by symptoms of sinus inflammation lasting >12 weeks. This illness is most commonly associated with either bacteria or fungi infections [1].Typically causes nasal congestion, blockage or discharge, and may be accompanied by facial pain or loss of smell. Examination reveals erythematous swollen nasal mucosa with pus [2]. The Task Force of the Rhinology and Paranasal Sinus Committee in 1997 suggested the term rhinosinusitis (RS), instead of sinusitis. [3] In one year, there were up to 73 million restricted activity days in patients with sinusitis. In addition, up to 14.7% of people in one National Health Interview Survey had sinusitis the preceding year. There are higher rates of sinusitis in the South, Midwest, and among women. Children younger than 15 years of age and adults aged 25 to 64 years are affected the most. Genetic factors influence the susceptibility to sinusitis. [4] Quality of life is patient’s ability to enjoy normal life activities. It is an important consideration in medical care. Some medical treatments can seriously impair quality of life without providing appreciable benefit, whereas others greatly enhance quality of life. The drastic negative effect of sinusitis on patients’ quality of life has been generally underappreciated and unrecognized. Recent studies show that patients score the effects of chronic sinus disease in areas such as bodily pain and social functioning as more debilitating than diseases such as angina, congestive heart failure, emphysema, chronic bronchitis, and lower back pain, to name a few. In the past, many patients were told they would just have to "live with" their sinus problem The most widely used patient-reported outcome measures (PROM) for CRS patients is the Sino-Nasal Outcome Test (SNOT) instrument. The SNOT instrument is a collection of several validated instruments (SNOT-16, SNOT-20, SNOT-22) defined by the number of included items. All of the SNOT instruments are derived from the Rhino-Sinusitis Outcome Measure (RSOM-31) There are many researches available who have tested validity and reliability of the SNOT 22 and have concluded it to be showing good reliability and validity for CRS.[5] In the study “Assessment of health -related quality of life in patients with chronic Rhinosinusitis – validation of the German Sino -Nasal Outcome Test 22â€concluded that it is reliable, valid and responsive questionnaire to assess symptoms, HRQOL and treatment response in CRS patients. Good psychometric properties were observed.6] A wide range of medical/surgical therapies has been used to treat chronic sinusitis. Modern Medical therapy includes antibiotics, corticosteroids, decongestants, antihistamines, mast�’cell stabilizers, anti�’leukotriene, nasal douching, immunotherapy and reduction of environmental factors [7]. Nasal Saline Irrigation is found to be beneficial while surgery is reserved for mostly complicated cases. Overuse and unnecessary selection of antibiotic drugs leads to increased drug resistance for respiratory pathogens which paves way to chronic disease and increased treatment costs [8]. Homoeopathic medicines are reported to cause improvement in a range of chronic recurring pathologies and especially respiratory disorders [9], [10]. Homoeopathy differs with regular medicine in its interpretation and application of several fundamental principles of science. It is these differences of interpretation and the practice growing out of them which give homoeopathy its individuality and continue its existence as a distinct school of medicine [11]. Considering chronic sinusitis not only physical suffering but a condition affecting whole quality of life of patient, “Effects of individualized homoeopathic medicine on quality of life of patients with chronic sinusitis using snot22 –†will be studied. |