| CTRI Number |
CTRI/2025/09/094888 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homeopathic Treatment for Allergic Rhinitis: Comparing Arundo Mauritanica with Individualized Medicines |
|
Scientific Title of Study
|
A Randomized Comparative Study to Evaluate Effectiveness of Arundo Mauritanica versus Individualized Homoeopathic Medicine for Allergic Rhinitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Prakash Yadav |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No S 23
Department of Organon of Medicine
Second Floor
36 B
Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
7007581534 |
| Fax |
|
| Email |
drapy555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvepriya |
| Designation |
Associate Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No S 23
Department of Organon of Medicine
Second Floor
36 B
Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8802756050 |
| Fax |
|
| Email |
doc.priyamalik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashid Akhtar |
| Designation |
Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No S 23
Department of Organon of Medicine
Second Floor
36 B
Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9871894545 |
| Fax |
|
| Email |
rakhtar8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homeoepathic Medical College and Hospital
36 B
Knowledge Park
Phase 1
Greater Noida
201306
Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Bakson Homeoepathic Medical College and Hospital |
| Address |
Room no G 22
Principal Office
Ground floor
36 B
Knowledge Park
Phase 1
Greater Noida |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amit Prakash Yadav |
Bakson Homeopathic Medical College and Hospital |
Outpatient Department
Room no 1
Ground Floor
36 B
Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7007581534
drapy555@gmail.com |
| Amit Prakash Yadav |
Dr. D.P. Rastogi Central Research Institute |
A 1
Opposite HCL
Sector 24
Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7007581534
drapy555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homeoepathic Medical College and Hospital |
Approved |
| Kendriya Homoeopathy Anusandhan Parishad |
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 |
Arundo Mauritanica |
Oral route of administration
30 pill size
Centisimal scale
First dose after case taking
Repetition of doses according to follow up
Duration of intervention is 6 months
|
| Intervention |
Homeopathic Medicines
Pill form of administration |
Oral route of administration
30 pill size
Centisimal scale
First dose after case taking
Repetition of doses according to follow up
Duration of 6 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of allergic rhinitis according to ARIA guidelines
Participants with mild to moderate symptoms of allergic rhinitis.
Willing to provide written informed consent.
Participants who have not taken anti-allergic medications for at least 2 weeks prior to enrollment. |
|
| ExclusionCriteria |
| Details |
Participants with nasal polyps, deviated nasal septum, chronic sinusitis, asthma, or other systemic illnesses.
Participants already under long-term antihistamines, corticosteroids, or immunotherapy.
Pregnant or lactating women.
Participants with any life-threatening illnesses (e.g., malignancies, uncontrolled systemic diseases) or classified as part of a vulnerable population.
Participants with psychiatric disorders or cognitive impairment affecting their ability to give consent or adhere to protocol.
Participants already participating in another clinical trials. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in allergic rhinitis symptoms using the Total Nasal Symptom Score (TNSS) in both groups. |
6 months for patient recruitment and intervention
6 months for follow ups
2 months for data analysis and interpretation
2 months of report writing. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the improvement in quality of life using the Mini Rhinoconjunctivitis Quality of Life Questionnaire.
Evaluate changes in serum IgE levels pre- and post treatment.
|
6 months for patient recruitment and intervention
6 months for follow ups
2 months for data analysis and interpretation
2 months of report writing. |
|
|
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)
|
27/09/2025 |
| 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="4"
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 aims to assess and compare the therapeutic outcomes of a specific remedy, Arundo mauritanica, with individualized constitutional homeopathic treatment in allergic rhinitis patients. It will be conducted as a double-blind randomized trial on 60 participants, using validated tools such as the Total Nasal Symptom Score (TNSS), Mini Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and serum IgE levels. Study duration is of 16 months. The study intends to generate clinical evidence to bridge the gap in research on Arundo’s role and provide clarity on its effectiveness relative to individualized homeopathy in improving symptoms and quality of life
|