| CTRI Number |
CTRI/2024/07/069845 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Homoeopathic medicine for chronic inflammation of nose and sinus |
|
Scientific Title of Study
|
Management of Chronic rhinosinusitis in adults with individualized homoeopathic medicines in different scales- An open label randomized triple arm pragmatic trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1305-8994 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Kumar |
| Designation |
Postgraduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Dept.of Practice of Medicine and special OPD,OPD no.21,265,266, Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9540568894 |
| Fax |
|
| Email |
dtdeepaktyagi0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupali Bhaduri |
| Designation |
Reader |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Dept.of Practice of Medicine and special OPD,OPD no.21,265,266, Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9571806989 |
| Fax |
|
| Email |
drrupalibhaduri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupali Bhaduri |
| Designation |
Reader |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Dept.of Practice of Medicine and special OPD,OPD no.21,265,266, Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9571806989 |
| Fax |
|
| Email |
drrupalibhaduri@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College & Hospital 265, 266, Acharya Prafulla Chandra Road, Kolkata, West Bengal 700009 |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265,266,Acharya Prafulla Chandra Road,Kolkata, West Bengal 700009 |
| 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 |
| Dr Deepak Kumar |
The Calcutta Homoeopathic Medical College and Hospital |
Dept.of Practice of Medicine and Special OPD (OPD no.21),265,266,Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL |
9540568894
dtdeepaktyagi0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of The Calcutta Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicines in centesimal scale plus concomitant care |
Experimental arm (IHMS in centesimal scale); Intervention is planned as administering indicated homoeopathic
medicines in centesimal scale. Each dose will consist of 4 cane sugar globules no.20 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on a clean tongue on empty stomach, dosage and repetition depend upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing their teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized homoeopathic medicine will be given on each occasion taking into consideration the presenting symptom totality, clinical history details,constitutional features, miasmatic expressions, and repertorisation using hompath and radar software when required with due consultation of materia medica and due consensus among three homoeopaths.All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Duration of treatment:3 months Concomitant Care: All the groups will be given general advices on Rest; Rest can help your body fight infection and recover faster.
Drink fluids; Fluids can help thin mucus, making it easier to pass through your sinuses.
Use a warm compress; A warm compress on your nose and forehead can help relieve sinus pressure.Keep your sinuses moist; You can use a neti pot or other nasal irrigators.Take a shower; The warm steam can help relieve sinus pressure. Use yoga; Yoga can help drain mucus.
|
| Comparator Agent |
Individualised homoeopathic medicines in decimal and fifty millesimal scale plus concomitant care |
Control arm I(Individualised homoeopathic medicine in decimal scale); Intervention is planned as administering only indicated homoeopathic medicines in decimal scale(X)
Control arm II (Individualised homoeopathic medicine in fifty millesimal scale); Intervention is planned as administering only indicated homoeopathic medicines in fifty millesimal scale (LM).In control arm I each dose will consist of 4 tablets of indicated medicine to be taken orally on a clean tongue on empty stomach.In contol arm II each dose will consist of 1 globules no.20 of indicated medicine in 100 ml distilled water to be taken orally on a clean tongue on empty stomach. dosage and repetition depend upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing their teeth within 30 minutes of taking the tablets,globules and will be asked to suck the globules rather than simply swallowing those. Single individualized homoeopathic medicine will be given on each occasion taking into consideration the presenting symptom totality, clinical history details,constitutional features, miasmatic expressions, and repertorisation using hompath and radar software when required with due consultation of materia medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Duration of treatment:3 months Concomitant Care; All the groups will be given general advices on Rest. Rest can help your body fight infection and recover faster.
Drink fluids can help thin mucus, making it easier to pass through your sinuses.
Use a warm compress; A warm compress on your nose and forehead can help relieve sinus pressure.
Keep your sinuses moist you can use a neti pot or other nasal irrigators.
Take a shower; The warm steam can help relieve sinus pressure.
Use yoga; Yoga can help drain mucus.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both sexes2.Patients of age between 18 to 65 years 3.Patient having chronic rhinosinusitis (CRS) [ICD-11 CA0A.Y] since 12 weeks or more, fulfilling the diagnostic criteria of AAO-HNS50 4.Case presenting with complaints like running nose, headache etc of chronic rhinosinusitis by using SINONASAL OUTCOME TEST (SNOT22)5.Patients undergoing X Ray paranasal sinus which show finding of chronic rhinosinusitis
6.Patients who have not taken any treatment since last 2 weeks for CRS 7.Patients who are literate, can read bengali, hindi, english, capable of filling the questionnaire 8.Providing written informed consent voluntarily
|
|
| ExclusionCriteria |
| Details |
1.Cases suffering from uncontrolled systemic illness or life-threatening infections2.Cases suffering from complications of CRS 3.Cases insisting for or in need of surgical interventions, major ENT surgery within last 6 months4.Patients with previous history of nose surgery5.Patients having DNS, cleft lip, otitis media6.Patients who are undergoing treatment with antibiotics, glucocorticoids or antihistamines during 2 weeks prior to enrolment in the study 7.Cases already undergoing homeopathic treatment for any chronic disease since last 6 months8.Substance abuse and/or dependence9.Pregnant, puerperial or lactating women10.Patients with psychiatric diseases11.Self-reported immune-compromised states
12.Vulnerable population – Unconscious, non-ambulatory, too ill for consultation, differently abled, terminally ill or critically ill patients, mentally disabled people13.Simultaneous participation in any other clinical trial
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sino Nasal Outcome Test
(SNOT22) |
At baseline, and every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EQ-5D-5L questionnaire |
At baseline, and every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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)
|
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
|
Chronic rhinosinusitis (CRS) is one of the most common chronic and debilitating conditions affecting 10-15% of the world population. An estimated 134 million Indians suffer from CRS. It has been shown to impair quality of life (QoL) and increase the risk of depression, anxiety, mood and sleep disorders and has significant morbidity and healthcare expenditure. Current management techniques mainly target to reduce inflammation with a variable results and endoscopic sinus surgery (ESS). Though homeopathy is one of the popular choice of CRS patients but effects of classical or individualized form of homeopathy (IH) remained unexplored. In this open label randomized triple arm pragmatic trial at The Calcutta Homoeopathic Medical College and Hospital, 111 patients suffering from CRS will be randomized to receive individualized homoeopathic medicines in centesimal scale(n=37), individualized homoeopathic medicines in decimal scale (n=37), individualized homoeopathic medicines in fifty millesimalscale (n=37) . We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homeopathy (IH) in treatment of CRS and to investigate whether there are any differences in outcomes between these three groups over 3 months of intervention. Sino-nasal Outcome Test-22 (SNOT-22) and EQ-5D-5L will be used as the primary and secondary outcome measures respectively. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any. |