| CTRI Number |
CTRI/2025/02/080727 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathic Treatment of Nasal Polyp |
|
Scientific Title of Study
|
A Comparative clinical study on the usefullness of Individualized homoeopathic medicine v/s Teucrium Marum Verum in the management of Nasal Polyp |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Bharti |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital, Viraj khand -1, Gomti Nagar, Lucknow |
| Address |
Department of Homoeopathic Materia Medica
State National Homoeopathic Medical College and Hospital, Viraj khand -1,Gomti Nagar, Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7388974789 |
| Fax |
|
| Email |
poojabharti102@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shashi Arya |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College and Hospital, Viraj khand -1 , Gomti Nagar, Lucknow |
| Address |
Department of Organon of Medicine, State National Homoeopathic Medical College and Hospital, Viraj khand -1, Gomti Nagar, Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
9450417584 |
| Fax |
|
| Email |
drshashiarya2105@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shashi Arya |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College and Hospital, Viraj khand -1 , Gomti Nagar, Lucknow |
| Address |
Department of Organon of Medicine, State National Homoeopathic Medical College and Hospital, Viraj khand -1, Gomti Nagar, Lucknow
Lucknow UTTAR PRADESH 226010 India |
| Phone |
9450417584 |
| Fax |
|
| Email |
drshashiarya2105@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital, Viraj khand- 1, Gomti Nagar , Lucknow |
|
|
Primary Sponsor
|
| Name |
Pooja Bharti |
| Address |
Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, Viraj khand -1, 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 Pooja Bharti |
State National Homoepathic Medical College and Hospital |
OPD NO-7, Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, Viraj khand-1, Gomti Nagar Lucknow-226010 Lucknow UTTAR PRADESH |
7388974789
poojabharti102@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: J339||Nasal polyp, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Intervention is planned as administering individualized homoeopathic medicine to a group of 30 patients suffering from Nasal Polyp after detailed case taking and repertorization. Individualized Homoeopathic medicine will be given in varying potencies of centesimal scale depending upon the susceptibility of the patient. Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine (preserved in 90% v/v ethanol) to be taken orally on empty. Dosage and repetition will depend upon the individual requirement of the case. |
| Comparator Agent |
Teucrium Marum verum |
Another group of 30 patient suffering from Nasal polyp will be administered Teucrium marum verum. The dose and repetition will depend upon the individualized requirement of the case |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Both male and female will be included.
2.Participants diagnosed with nasal polyp
3.Age group of 16 -45years suffering from nasal polyp will be included
4.Participants who will be ready to give consent and assent.
|
|
| ExclusionCriteria |
| Details |
1.Participants on other medication .
2.Participants with other upper respiratory tract infections (laryngitis, pharyngitis, diphtheria, etc.)
3.Pregnant and lactating female.
4.Uncontrolled systemic or psychiatric illness .
5.Participants with other respiratory infections (chronic bronchitis, bronchial Asthma, cystic fibrosis).
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in scoring in before and after treatment using SNOT 20 in patients with nasal polyp at baseline and after 6 months of treatment to compare the effectiveness of Teucrium Marum Verum and Individualized Homoeopathic medicines |
12 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in size of nasal polyp using Xray-PNS at baseline and every 3 month of treatment |
12weeks, 24 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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
|
Nasal polyps are a manifestation of chronic rhinosinusitis with nasal polyps (CRSwNP), which is a chronic inflammatory condition affecting the sinus and nasal cavities. These polyps are often the result of long-term inflammation, frequently linked to conditions like chronic rhinitis, asthma, and allergies. They are common in adults, particularly those aged 40-60, and more prevalent in males. Symptoms include nasal congestion, loss of smell, chronic runny nose, and sometimes facial pain or headaches. The exact cause of nasal polyps remains unknown, but it is linked to chronic inflammation. The condition can significantly affect a person’s quality of life and impose substantial financial costs due to medical expenses and lost productivity. Treatment typically involves a combination of medical management (such as antihistamines and steroids) and surgery for severe cases. Homeopathic treatments, including Teucrium marum verum, have shown some promise in treating nasal polyps, although further research is needed to assess their efficacy fully. The study outlined aims to evaluate the comparative efficacy of individualized homeopathic treatment versus Teucrium marum verum in managing nasal polyps, using tools like the SNOT-20 questionnaire to measure symptom severity and patient well-being. |