| CTRI Number |
CTRI/2022/03/041022 [Registered on: 11/03/2022] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Sinusitis treatment in homeopathy |
|
Scientific Title of Study
|
A clinical study to assess the effectiveness of individualized homoeopathic medicines in the treatment of chronic sinusitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharathinesan M |
| Designation |
Junior resident doctor |
| Affiliation |
Nehru homoeopathic medical college and hospital |
| Address |
Nehru homoeopathic medical college and hospital,
Defence colony, B block
New delhi
South
DELHI
110024
India |
| Phone |
9677484378 |
| Fax |
|
| Email |
bharathinesan1019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thankaraj B |
| Designation |
Reader (NFSG) |
| Affiliation |
Nehru homoeopathic medical college and hospital |
| Address |
Nehru homoeopathic medical college and hospital,
Defence colony, B block
New dehli
South
DELHI
110024
India |
| Phone |
9868396618 |
| Fax |
|
| Email |
drthankaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharathinesan M |
| Designation |
Junior resident doctor |
| Affiliation |
Nehru homoeopathic medical college and hospital |
| Address |
Nehru homoeopathic medical college and hospital,
Defence colony, B block
New delhi
South
DELHI
110024
India |
| Phone |
9677484378 |
| Fax |
|
| Email |
bharathinesan1019@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patients and in patients department of nehru homoeopathic medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Bharathinesan M |
| Address |
Nehru homoeopathic medical college and hospital, defence colony, B block, new delhi 110024 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Bharathinesan M |
Nehru homoeopathic medical college and hospital |
Department of ayush, Defence colony, b block, south delhi, new delhi 110024
South
DELHI |
9677484378
bharathinesan1019@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 |
Administration of individualized homoeopathic medicines |
after obtaining consent and asked all questions in case performa medicine prescribed according to individualization , medicine taken on oral route, dose and repetitin depends upon subsequent follow up along with steam inhalation two times per day and adviced to avoid cold exposures as a general management. all medicines procured from good manufacturing practice(GMP). Duration of therapy 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having chronic sinusitis more then 12 weeks.
Patients who have not taken any treatment since last two weeks for chronic sinusitis.
Patients willing to take homoeopathic treatment |
|
| ExclusionCriteria |
| Details |
Patients suffering from uncontrlled systemic diseases like cancer, vital organ failures, uncontrolled infections.
Immunocompromised patients,
psychiatrically unstable patietnts,
pregenent and lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Chronic sinusitis assessment score |
Every 4 weeks upto 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric rating scale |
Every 4 weeks upto 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2022 |
| Date of Study Completion (India) |
15/03/2023 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is an open label, prospective, uncontrolled clinical trail to assess the effecetiveness of individualized homoeopathic medicines in the treatment of chronic sinusitis. Hypothesis depends upon significant changes in the symptoms of chronic sinusitis after six months of intervention with homoeopathic medicines, no significant changes in the symptoms null hypothesis applied, if significant changes in the symptoms alternative hypothesis is applied. Objectives are to assess the treatment outcome by using chronic sinusitis assessment score as primary treatment outcome and using numeric rating scales as secondary outcome. To shortlist the frequently indiacated medicines in the treatment of chronic sinusitis. Study duration is one year. 30 patients are included in the study, patients are followed every month upto six month, the outcomes are measured every 4 weeks upto 24 weeks.
|