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
|
|
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
|
|
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
|
|
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. |