| CTRI Number |
CTRI/2024/12/077925 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Lemna Minor 6c in cases of Nasal Polyp |
|
Scientific Title of Study
|
Understanding the miasmatic background of nasal polyp and effectiveness of lemna minor 6c in its treatment a prospective single arm pre post clinical study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annu Verma |
| Designation |
Pg scholar |
| Affiliation |
Bakson homoeopathic medical college and hospital |
| Address |
Department of organon of medicine and homoeopathic philosophy
second floor
room no S2
Bakson homoeopathic medical college and hospital
36 B
Knowledge park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7440745447 |
| Fax |
|
| Email |
annuv293@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashid Akhtar |
| Designation |
HOD & Guide |
| Affiliation |
Bakson homoeopathic medical college and hospital |
| Address |
Department of organon of medicine and homoeopathic philosophy
second floor
room no S2
Bakson homoeopathic medical college and hospital
36 B
Knowledge park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9871894545 |
| Fax |
|
| Email |
rashid3027@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashid Akhtar |
| Designation |
HOD & Guide |
| Affiliation |
Bakson homoeopathic medical college and hospital |
| Address |
Department of organon of medicine and homoeopathic philosophy
second floor
room no S2
Bakson homoeopathic medical college and hospital
36 B
Knowledge park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9871894545 |
| Fax |
|
| Email |
rashid3027@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeoepathic Medical college and Hospital 36B Knowledge park 1 Greater Noida UP 201310 |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Principal office
Ground floor
Room no G22
Bakson Homoeopathic Medical
College and Hospital
B 36 Knowledge Park 1
Gautam Buddha Nagar
Greater Noida UP 201310 |
| Type of Sponsor |
Private 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 |
| Dr Annu Verma |
Bakson Homoeopathic Medical College and Hospital |
Out Patient Department (OPD)
Ground floor
Room no.1
Bakson Homoeopathic Medical College and Hospital
B36 Knowledge park 1
Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
7440745447
annuv293@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bakson institutional ethics committee |
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 |
Lemna Minor 6c |
pill form ,30 pill size,oral route administration,6c potency ,first dose at the time of case taking subsequent doses according to follow ups |
| Comparator Agent |
NIL |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female will be included.
Participants diagnosed with nasal polyp
Age group of 16 -45years suffering from nasal polyp will be included
Participants who will be ready to give consent and assent.
Rhinoscopy findings of nasal polyp
|
|
| ExclusionCriteria |
| Details |
Participants on other medication
Participants with other upper respiratory tract infections (laryngitis , pharyngitis , diphtheria ,etc)
Pregnant and lactating female.
Uncontrolled systemic or psychiatric illness
Participants with other respiratory infections (chronic bronchitis, bronchial Asthma ,cystic fibrosis
Participants with suffering of sinusitis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes will be observed on SNOT20 Score Scale
Changes can be positive or negative or no change |
SNOT20 SCORE Scale will be used at baseline, every 4 weeks upto 24 weeks.
15 month study.
6 months enrolment
6 months follow up
3 months analysis
first dose at the time of case taking and subsequent doses according to follow ups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
20/12/2024 |
| 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="3"
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 a prospective single arm pre -post study ,to see the miasmatic background of nasal polyp and effectiveness of Lemna Minor 6c in cases of Nasal Polyp by using the SNOT 20 scale . |