| CTRI Number |
CTRI/2025/08/093642 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Other (Specify) [Yoga(jalneti)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of homoeopathic medicines in the treatment of chronic rhinosinusitis. |
|
Scientific Title of Study
|
To Explore the Effectiveness of Individualized Homoeopathic medicines vs Saline Nasal Irrigation (Jalneti) in Treatment of Chronic Rhinosinusitis: A Randomized Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayushi Gupta |
| Designation |
PG scholar |
| Affiliation |
Dr BR Sur Homoeopathic Medical College, Hospital and Research Centre |
| Address |
Department Of Materia Medica, Third Floor, Dr BR sur Homoeopathic Medical College, Hospital and Research Centre Nanakpura Moti Bagh New Delhi
South West
DELHI
110021
India |
| Phone |
9873803049 |
| Fax |
|
| Email |
Ayushigupta7502@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U Rajeev Nair |
| Designation |
Professor & HOD, Deparment of Homoeopathic Materia Medica |
| Affiliation |
Dr BR Sur Homoeopathic Medical College, Hospital and Research Centre |
| Address |
Department Of Homoeopathic Materia Medica, Third Floor, Dr BR sur Homoeopathic Medical College, Hospital and Research centre Nanakpura MotiBagh New Delhi
South West
DELHI
110021
India |
| Phone |
7994273285 |
| Fax |
|
| Email |
drrajivh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayushi Gupta |
| Designation |
PG scholar |
| Affiliation |
Dr BR Sur Homoeopathic Medical College, Hospital and Research Centre |
| Address |
Department Of Materia Medica, Third Floor, Dr BR sur Homoeopathic Medical College, Hospital and Research Centre Nanakpura Moti Bagh New Delhi
South West
DELHI
110021
India |
| Phone |
9873803049 |
| Fax |
|
| Email |
Ayushigupta7502@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh New Delhi 110021 |
|
|
Primary Sponsor
|
| Name |
Dr Ayushi Gupta |
| Address |
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh, New Delhi, 110021, INDIA |
| 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 |
| Dr Ayushi Gupta |
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre. |
Department Of Homoeopathic Materia Medica, Third Floor,
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh, New Delhi, 110021
South West
DELHI |
9873803049
Ayushigupta7502@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
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J32||Chronic sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HOMOEOPATHIC MEDICINES |
HOMOEOPATHIC MEDICINE WILL BE ADMINISTERED IN CENTESIMAL POTENCIES, SELECTED ACCORDING TO HOMOEOPATHIC PRINCIPLES. THE DOSE AND REPETITION WILL BE DECIDED AS PER THE REQUIREMENT OF EACH CASE. THE ROUTE OF ADMINISTRATION WILL BE ORAL, IN THE FORM OF GLOBULES. DURATION:6 MONTHS |
| Comparator Agent |
PLACEBO WITH SALINE NASAL IRRIGATION (JALNETI) |
IDENTICAL LOOKING PLACEBO IN GLOBULES FORM WILL BE GIVEN ALONG WITH SALINE NASAL IRRIGATION (JALNETI). EACH PATIENT WILL BE FIRST ASSESSED BY A YOGA EXPERT.
DURATION : 6 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Persons having symptoms of sinusitis for more than 12 weeks
2. Both sexes of age group above 18 years and below 60 years.
3. Persons having symptoms of chronic rhinosinusitis clinically as well as with x ray studies
suggestive of sinusitis will be included
4. Persons having sinusitis irrespective of the association with other diseases like asthma,
allergic rhinitis, nasal polyps will be included. |
|
| ExclusionCriteria |
| Details |
1. Persons suffering from systemic illness with life threatening complications.
2. Persons suffering with complications of sinusitis with severe obstruction of nose due to DNS in need of surgical interventions.
3. Persons already undergoing homoeopathic treatment for any chronic disease without
washout period for atleast 2 weeks.
4. pregnant or lactating women , patients with psychiatric disease , and those with
immunocompromised state are to be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The trial is expected to indicate that individualized homeopathic medicine will yield better results
than saline nasal irrigation (Jalneti) in the treatment of chronic rhinosinusitis. |
1 year (12 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The study is expected to demonstrate improved patient quality of life, evaluated subjectively using the SNOT-22 questionnaire in patients of chronic rhinosinusitis.
2. At the end of study it is expected that the radiographic findings of paranasal sinuses will show improvement following the treatment.
3. This research aims to identify most commonly indicated homoeopathic medicines in treatment of
chronic rhinosinusitis.
4. It is expected that there may be subjective (symptomatic) and objective (X-Ray paranasal sinuses) improvement along with improvement in general well-being, without any substantial medicinal adverse effects. |
1 year(12 months) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="0"
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
|
This study compares the effectiveness of individualized homoeopathic medicines and saline nasal irrigation (jalneti) along with placebo in treating patients with chronic rhinosinusitis , aged 18-60 years. Patients will be randomly assigned to receive either individualized homoeopathic medicines or saline nasal irrigation (jalneti) along with placebo. The study will measure the outcome using x-ray (paranasal sinuses) and SNOT 22 (SINO NASAL OUTCOME TEST) scores. The primary goal is to compare the efficacy of these two approaches in managing chronic rhinosinusitis , improving quality of life, and reducing disease severity . The results will provide valuable insights into the effectiveness of individualized homoeopathic medicine and saline nasal irrigation (jalneti) in treating chronic rhinosinusitis. |