| CTRI Number |
CTRI/2025/09/094709 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study on the efficacy of sanguinaria nitricum and formica rufa in the management of nasal polyp |
|
Scientific Title of Study
|
A randomized comparative clinical study on the efficacy of sanguinaria nitricum and formica rufa 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 |
Dr PINKY SAINI |
| Designation |
PG SCHOLAR |
| Affiliation |
Homoeopathy University |
| Address |
Department of Practice of Medicine Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9587003779 |
| Fax |
|
| Email |
pihusaini8769@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Virendra Chauhan |
| Designation |
Professor and HOD |
| Affiliation |
Homoeopathy University |
| Address |
Department of Practice of Medicine Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9983548853 |
| Fax |
|
| Email |
pmpg2724dept@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Virendra Chauhan |
| Designation |
Professor and HOD |
| Affiliation |
Homoeopathy University |
| Address |
Department of Practice of Medicine Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9983548853 |
| Fax |
|
| Email |
pmpg2724dept@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. M.P.K Homeopathic Medical College, Hospital and Research
Center, Plot 10,11,12, Saipura, Sanganer, Jaipur, RJ, 302029 |
|
|
Primary Sponsor
|
| Name |
Dr. M.P.K Homeopathic Medical College, Hospital and Research Center |
| Address |
Plot 10,11,12, Saipura, Sanganer,Jaipur,Rajasthan |
| 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 Pinky Saini |
Dr Girendra pal Homoeopathic Hospital and Research Centre |
Department of Practice of Medicine OPD Room No 1 Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN |
9587003779
pihusaini8769@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Homoeopathy University Jaipur |
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 |
Formica Rufa |
All the Patient having symptoms of nasal polyp will be prescribed Formica rufa the prescription will be based upon randomization.Given thrice a day,through oral route, given in globule form |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SANGUINARIA NITRICUM |
All the Patient having symptoms of nasal polyp will be prescribed sanguinaria nitricum the prescription will be based upon randomization, given thrice a day,through oral route, given in globule form |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of all ages and both sexes.
Giving valid written Consent and Assent Patient/from parent/guardian
Patient presenting with pre-diagnosed case of nasal polyp
Patient without any emergency/life threatening condition |
|
| ExclusionCriteria |
| Details |
Patient with cognitive or psychiatric disorders that affect ability to follow protocol.
Drug allergy.
Uncontrolled systemic illnesses.
Pregnant Female
Lactating Mother |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to the scores obtained pre and post from SNOT 22 |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the efficacy of sanguninaria nitricum and formica rufa |
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
26/09/2025 |
| 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
|
Aim To compare the effectiveness of Sanguinaria Nitricum and Formica Rufa in the management of Nasal Polyp Objectives 1 To evaluate and compare the clinical efficacy of Sanguinaria Nitricum and Formica Rufa in the management of nasal polyp 2 To compare the improvement in patients of both groups using SNOT 22 scale |