| CTRI Number |
CTRI/2021/02/031476 [Registered on: 23/02/2021] Trial Registered Prospectively |
| Last Modified On: |
23/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines in sinus complaints |
|
Scientific Title of Study
|
Individualized homeopathic medicines in chronic rhinosinusitis: Randomized,
double-blind, placebo-controlled, feasibility trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1264-6810 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumana Sengupta |
| Designation |
Lecturer, Dept. of Practice of Medicine |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Research OPD; Room no. 12, 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9748192242 |
| Fax |
|
| Email |
sumanaseng@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Shyamal Kumar Mukherjee |
| Designation |
Principal and Administrator |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Principals Chamber, Administrative Division, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831113383 |
| Fax |
|
| Email |
shyamalmukhergee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samiul Ansary |
| Designation |
4th BHMS undergraduate student |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
8670350709 |
| Fax |
|
| Email |
samiulansary12@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046 |
| 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 |
| Sumana Sengupta |
D. N. De Homoeopathic Medical College and Hospital |
Research OPD, Room no 12, 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046
Kolkata
WEST BENGAL |
9748192242
sumanaseng@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Individualized homeopathic medicines |
It is planned as administering indicated homeopathic remedies in centesimal potencies, as decided appropriate to the case or condition. Each dose shall consist of 4 globules (no. 30) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and
repetition depending upon the
individual requirement of the
cases. All medicines will be procured from a Good Manufacturing Practice(GMP)-certified firm. Route of
administration: Oral. All the patients will be given general advices on saline steam inhalations and acute homeopathic remedies as rescue medication optionally, if and when required. But other medicines like antibiotics, gluco-corticosteroids and antiallergics will not be permitted. Duration of therapy: 2 months. |
| Comparator Agent |
Placebo |
Placebo, identical in appearance with and indistinguishable from
the medicine. Each dose of placebo shall consist of 4 globules (no. 30) of cane sugar, moistened with rectified spirit, to be taken
orally on clean tongue with
empty stomach; dosage and
repetition depending upon the
individual requirement of the
cases. All sundry items will be procured from a Good
Manufacturing Practice
(GMP)-certified firm. Route of
administration: Oral. All the patients will be given general advices on saline steam inhalations and acute homeopathic remedies as rescue medication optionally, if and when required. But other medicines like antibiotics, gluco-corticosteroids and antiallergics will not be permitted. Duration of therapy: 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases suffering from chronic rhinosinusitis for 12 weeks or more (2020 ICD-10-CM diagnosis code J32.9), but had not taken any treatment since last 2 weeks, and fulfilled the diagnostic criteria of AAO-HNS
2. Age 18-65 years
3. Patients of either sex
4. Patients who are literate and capable of filling the questionnaire and providing written informed consent |
|
| ExclusionCriteria |
| Details |
1. Cases suffering from uncontrolled systemic illness or life-threatening infections
2. Cases suffering from complications of CRS
3. Cases insisting for or in need of surgical interventions
4. Cases already undergoing homeopathic treatment for any chronic disease
5. Substance abuse and/or dependence
6. Pregnant, puerperial or lactating women
7. Patients with psychiatric diseases
8. Self-reported immune-compromised states |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sino-nasal Outcome Test-22 (SNOT-22) questionnaire score |
At baseline and after 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EQ-5D-5L questionnaire and VAS scores |
At baseline and after 2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/02/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet, to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included www.dndeofficial.org/).
- For how long will this data be available start date provided 01-12-2021 and end date provided 30-11-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
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 through RCTs. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 40 patients suffering from CRS will be randomized to receive either individualized homoeopathic medicines (verum; n=20) or identical-looking placebo (control; n=20). 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 two groups over 2 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. Results will be published in scientific journals. |