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CTRI Number  CTRI/2018/03/012557 [Registered on: 15/03/2018] Trial Registered Prospectively
Last Modified On: 09/09/2019
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 sinusitis 
Scientific Title of Study   Efficacy of constitutional homoeopathic medicines in patients with non-surgical chronic rhinosinusitis: a prospective, randomized, double-blind, placebo-controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1210-7201  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pankhuri Misra 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  Department of Homoeopathic Materia Medica, OPD room no. 13, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  8375089437  
Fax    
Email  drpankhuri7hc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chintamani Nayak 
Designation  Lecturer, Dept. of Homoeopathic Materia Medica 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  Department of Homoeopathic Materia Medica, OPD room no. 13, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  9433161854  
Fax    
Email  drcnayak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Chintamani Nayak 
Designation  Lecturer, Dept. of Homoeopathic Materia Medica 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  Department of Homoeopathic Materia Medica, OPD room no. 13, Block GE, Sector III, Salt Lake


WEST BENGAL
700106
India 
Phone  9433161854  
Fax    
Email  drcnayak@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  National Institute of Homoeopathy Ministry of AYUSH Govt of India 
Address  Block GE, Sector III, Salt Lake, Kolkata, West Bengal 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pankhuri Misra  National Institute of Homoeopathy, Govt. of India  Dept of Homoeopathic Materia Medica, OPD room no. 13, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL 
8375089437

drpankhuri7hc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, Non-surgical chronic rhino-sinusitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Indistinguishable placebo plus saline inhalation  Placebo each dose consists of 4 cane sugar globules no. 10 moistened with 90% v/v ethanol; indistinguishable from verum. To be taken thrice a day orally on clean tongue in empty stomach. Duration of therapy: 4 months 
Intervention  Individualized homoeopathic medicines in centesimal potencies plus saline inhalation  In centesimal potencies, each dose shall consist of 4 cane sugar globules no. 10 medicated with the indicated medicine, preserved in 90% v/v ethanol. Repetition 24, 12 or 8 hourly or even oftener, depending upon the individual requirement of the case. Each dose to be taken orally on clean tongue in empty stomach. Duration of therapy: 4 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of both sexes
2. Patients of age between 18 and 60 years
3. Patients having chronic rhino-sinusitis (CRS) since 12 weeks or more, fulfilling the diagnostic criteria of AAO-HNS.
4. Patients who have not taken any treatment since last 2 weeks for CRS.
5. Patients who are literate, can read Bengali, capable of filling the questionnaire and providing informed consent.
6. Patients willing to take only homoeopathic medicines 
 
ExclusionCriteria 
Details  1. Patients suffering from other uncontrolled systemic diseases (like DM, Cancer and Thyroid diseases etc.), uncontrolled infections or any vital organ failure.
2. Patients suffering from the complications of CRS.
3. Patients who are insisting for or in need of surgical interventions.
4. Patients who are undergoing treatment with antibiotics, glucocorticosteroids or antihistamines during 2 weeks prior to enrolment in the study.
5. Psychiatrically unstable patients
6. Self-reported immune-compromised patients
7. Substance abuse and/or dependence
8. Pregnant women and lactating mothers
9. Already undergoing homoeopathic treatment for any chronic disease since last 6 months 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Sino-nasal Outcome Test 20 (SNOT-20) questionnaire (translated Bengali version)  Baseline, 2 months, 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
EQ-5D-5L questionnaire (Bengali version)  Baseline, 2 months, 4 months 
Five numeric rating scales (0-10) measuring severity of sneezing, rhinorrhoea, post-nasal drip (PND), facial pain or pressure, and loss of sense of smell  Baseline, 2 months, 4 months 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   19/03/2018 
Date of Study Completion (India) 07/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet; to be published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Chronic sinusitis is one of the most prevalent chronic illnesses all over the world. An estimated 134 million Indians suffer from chronic rhinosinusitis (CRS), 1 in 8 Indians suffer from CRS. According to the, National Ambulatory Medical Care Survey, sinusitis is the fifth most common diagnosis treated with antibiotics. Thus CRS has significant economic implications. The small benefit gained for short duration may be masked by the negative effects of antibiotics and the high recurrence rate of CRS. Homeopathy may hold promise in successful treatment of CRS, but has remained under-researched. In this double-blind, randomized, placebo-controlled, clinical trial at National Institute of Homoeopathy, 62 patients will be randomized to either individualized homoeopathic treatment + saline inhalation (n=31) or indistinguishable placebo + saline inhalation (n=31) to examine whether individualized homoeopathy have any different effect from placebo in treatment of CRS. Sino-nasal Outcome Test 20 (SNOT-20) questionnaire (SNOT-20) scores, EQ-5D-5L scores, and 5 numeric rating scales measuring severity of sneezing, rhinorrhoea, post-nasal drip (PND), facial pain or pressure, and loss of sense of smell will be assessed at baseline, after 2 months, and after 4 months. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.

 
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