| CTRI Number |
CTRI/2025/08/093356 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing The Role Of Individualized Homoeopathic Medicines And Allium Cepa In Treatment Of Allergic Rhinitis |
|
Scientific Title of Study
|
Evaluating The Effectiveness Of Individualized Homoeopathic Medicines Vs Allium Cepa In Treatment Of Allergic Rhinitis: 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 Nancy Singhal |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Homoeopathic Materia Medica, Third Floor,
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh, New Delhi
South West
DELHI
110021
India |
| Phone |
9582732424 |
| Fax |
|
| Email |
singhalnancy98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U Rajeev Nair |
| Designation |
Professor & HOD, Department Of Homoeopathic Materia Medica |
| Affiliation |
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Homoeopathic Materia Medica, Third Floor,
Dr B R 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 Nancy Singhal |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Homoeopathic Materia Medica, Third Floor,
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh, New Delhi
South West
DELHI
110021
India |
| Phone |
9582732424 |
| Fax |
|
| Email |
singhalnancy98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Sur Homoeopathic Medical College Hospital And Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Nancy Singhal |
| 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 Nancy Singhal |
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre |
OPD and IPD, Dr B R Sur Homoeopathic Medical College Hospital And Research Centre Nanakpura Motibagh New Delhi 110021
South West
DELHI |
9582732424
singhalnancy98@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: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Allium Cepa |
Allium Cepa will be
administered in centesimal
potencies, selected according to homoeopathic principles. The dose and repetition will be done as per the requirement of each case. The route of
administration will be Oral, in globules form. Duration: 6
months |
| Intervention |
Individualized Homoeopathic
Medicines |
Individualized Homoeopathic
Medicines will be administered
in centesimal potencies,
selected according to
homoeopathic principles. The
dose and repetition will be done as per the requirement of each case. The route of
administration will be Oral, in globules form. Duration: 6
months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Both sexes of age group from 12 to 60 years.
2.Mild to moderate cases will be taken. |
|
| ExclusionCriteria |
| Details |
1. Allergic rhinitis patients suffering from any life-threatening illness who are terminally
ill, under immunosuppressive treatment or self-reported immune-compromised state.
2. Nasal abnormalities causing obstruction.
3. Patients with complication of the allergic rhinitis or having other atopic conditions like
asthma and Chronic Obstructive Pulmonary Disorder (COPD)
4. Patients of malignancy or too sick for consultation.
5. Diagnosed case of mental illness / psychiatric/ other uncontrolled life threatening illness
affecting quality of life /any organ failure.
6. Pregnant ladies are excluded.
7. Substance abuse and or dependence. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Individualized homoeopathic medicines are expected to yield better therapeutic results as compared to Allium cepa in the treatment of Allergic Rhinitis patients. |
1 year (12 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) This study will aid in identifying the most effective homoeopathic medicines for the
management of Allergic Rhinitis.
(2) This study expects an improvement in patient’s quality of life, assessed subjectively through
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in patients of Allergic Rhintis.
(3) At the end of study it is expected that the serum IgE levels and absolute eosinophil count will show improvement following the treatment. |
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 homeopathic medicines and Allium Cepa in treating patients with Allergic Rhinitis, aged 12-60 years. Patients will be randomly assigned to receive either individualized homeopathic medicines or Allium Cepa. The study will measure the outcomes using Serum IgE, Absolute Eosinophil Count and RQLQ ( Rhinoconjunctivitis Quality of Life Questionnaire) scores. The primary goal is to compare the efficacy of these two approaches in managing Allergic rhinitis, improving quality of life, and reducing disease severity. The results will provide valuable insights into the effectiveness of homeopathic approaches in treating Allergic rhinitis. |