| CTRI Number |
CTRI/2025/02/080919 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic management of rhinosinusitis.
|
|
Scientific Title of Study
|
Utility of Repertory of Herings Guiding Symptoms of Our Materia Medica By Calvin B.Knerr In The Treatment OF Rhinosinusitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khadijah arshad |
| Designation |
Postgraduate junior resident |
| Affiliation |
State national homoeopathic medical college and hospital |
| Address |
Department of Homoeopathic Repertory and Case-taking State National Homoeopathic Medical College and Hospital,1- Viraj Khand, Gomtinagar Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7355740039 |
| Fax |
|
| Email |
khadijaharshad193@Gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sutapa Nandi |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital, 1- Viraj Khand, Gomti Nagar Lucknow |
| Address |
Department of Homoeopathic Repertory and Case-taking State National Homoeopathic Medical College and Hospital, 1- Viraj Khand, Gomti Nagar Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
6351407744 |
| Fax |
|
| Email |
drnandisutapa@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Khadijah Arshad |
| Designation |
Postgraduate junior resident |
| Affiliation |
State National Homoeopathic Medical College and Hospital,1-Viraj Khand ,Gomti Nagar ,Lucknow |
| Address |
Department of Homoeopathic Repertory and Case-taking State National Homoeopathic Medical College and Hospital, 1- Viraj Khand, Gomti Nagar Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7355740039 |
| Fax |
|
| Email |
khadijaharshad193@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital, 1-Viraj Khand Gomti Nagar, Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Khadijah Arshad |
| Address |
Department of Homoeopathic Repertory and Case-taking, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand Gomti Nagar, Lucknow ,Uttar Pradesh -226010
|
| 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 Khadijah Arshad |
State National Homoeopathic Medical College And Hospital |
OPD No-7,Department of Homoeopathic Repertory And Case Taking, State National Homoeopathic Medical College And Hospital,1-Viraj Khand, Gomtinagar Lucknow-226010 UP,India.
Lucknow
UTTAR PRADESH Lucknow UTTAR PRADESH |
7355740039
khadijaharshad193@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee State National 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 |
Individualize homoeopathic Medicine. |
Intervention- The individualized homoeopathic medicine
will be selected according to the totality of symptoms.
Dosage- Medicine will be given in varying potencies of
decimal/ centesimal scales as identified from
detailed case taking.Each dose shall consist of cane
sugar medicated with single medicine. Route-Medicine
will be administered via oral route. Dosage and
repetition will depend upon the individual requirement of
the cases as per the guidelines from organon of
medicine. The patient will be called for follow up after
every 15 days and final assessment will be done after 6
months. At every follow up after reexamining the case it
will be decided whether the patient will receive a dose of
individualized homoeopathic medicine or placebo. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient of all age group.
2)Both the sexes will be considered
3)Diagnostic criteria are mainly on clinical presentation and X-ray PNS will be done when required.
4)Those who agree to give consent to participate in the study.
5)Those who are willing to have regular follow up visits
|
|
| ExclusionCriteria |
| Details |
1)Patients with complications of other autoimmune diseases.
2)Patients with Immunocompromised disease
3)Mentally retarded patients
4)Patients with congenital defect.
5)Rhinosinusitis presenting with complications like orbital abscess, mucopyocele, oedema of eyelids, meningitis.
6)Patients with chronic respiratory condition like severe asthma.
7)Paranasal sinus and nose surgery.
8)Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Rhinosinusitis SNOT-22 at baseline and after 6 months of treatment to know the utility of individualized homoeopathic medicine. |
12weeks, 24 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the X-ray results at baseline and after 3
months of treatment to know the utility of individualized
homoeopathic medicine. |
4 weeks, 12
weeks |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2025 |
| 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="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
|
This is an open label, single arm, prospective, interventional study which aims to assess the utility of homoeopathic medicine in the treatment of Rhinosinusitis with the help of Hering’s guiding symptoms of our materia medica by Calvin B. Knerr repertory. Individualized homoeopathic medicine will be prescribed in decimal/ centesimal scale after detailed case taking and repertorization. Rhinosinusitis is a group of disorders characterized by inflammation of the mucosa of the nose and paranasal sinuses. Prevalence rate of chronic rhinosinusitis range from 1% to 12% worldwide. . 1 in 8 Indians is hit by chronic sinusitis. Among respiratory infections, rhinosinusitis is one of the most common illnesses that affects a high proportion of the population. Conventional medicines treats rhinosinusitis with the help of antibiotics, steroids, antihistamines for its relief. The overuse of nasal decongestants can also lead to a condition called rebound congestion in which the person has prolonged stuffiness and nose blockage. Homoeopathic remedies can offer gentle and safe treatment for patients suffering from Rhinosinusitis. Homoeopathy treats the person as a whole. This includes a detailed medical history of the patient, family and causative factors. Any underlying predisposing factor and susceptibility is also considered.Therefore, the present study is undertaken to explore how individualized homoeopathic medicine selected on the basis of Repertory Of HERING GUIDING’S SYMPTOMS OF OUR MATERIA MEDICA BY CALVIN B. KNERR useful in the treatment of Rhinosinusitis .Individualized homoeopathic medicine has shown very good results .However ,research studies to further elaborate as well as consolidate our knowledge is still lacking. There has been a limited research on Repertory Of HERING’S GUIDING SYMPTOMS OF OUR MATERIA MEDICA BY CALVIN B.KNERR in the treatment of rhinosinusitis. Therefore, intend to undertake this study to research in this particular domain. |