| CTRI Number |
CTRI/2025/09/094261 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the effectiveness of homeopathic medicine Hstaminum hydrochloricum in cases of allergic rhinitis. |
|
Scientific Title of Study
|
The effectiveness of Histaminum hydrochloricum in allergic rhinitis: a clinical verification study |
| 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 SONAL PANCHMATIYA |
| Designation |
Professor Department Of Homeopathic Materia Medica |
| Affiliation |
Dr V H Dave Homoeopathic Medical College, Anand |
| Address |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT
388001
India |
| Phone |
9426432585 |
| Fax |
|
| Email |
dr.sonal2705@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Panchmatiya |
| Designation |
Professor Department Of Homeopathic Materia Medica |
| Affiliation |
Dr V H Dave Homoeopathic Medical College |
| Address |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT
388001
India |
| Phone |
9426432585 |
| Fax |
|
| Email |
dr.sonal2705@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Riddhi Shah |
| Designation |
PG Scholar |
| Affiliation |
Dr V H Dave Homoeopathic Medical College, Anand |
| Address |
6 Relief Colony Road Ayurvedic Cross Road Outside Panigate Waghodia Road
Vadodara
GUJARAT
390019
India |
| Phone |
9265595755 |
| Fax |
|
| Email |
shahridi1309@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat |
|
|
Primary Sponsor
|
| Name |
DR Riddhi Shah |
| Address |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat |
| 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 Riddhi Shah |
Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat 388001 |
Room No 4 Department of Medicine Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road
Anand
GUJARAT |
9265595755
shahridi1309@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECVHDHMC |
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 |
| Intervention |
HISTAMINUM HYDDROCHLORICUM |
6C 30C 200C 1M OD BD TDS THE POTENCY REPETATION OF HISTAMINUM HYDROCHLORICUM WILL BE SELECTED DEPENDING UPONE THE SUSCEPTIBILITY OF PATIENT |
| Comparator Agent |
no comparator |
no comparator |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient 10-80 years will be screened irrespective of gender.
The cases with Allergic Rhinitis where Histaminum hydrochloricum is indicated will be included.
Only those participants who willingly give informed consent will be enrolled in the study. They will be expected to adhere to the prescribed homoeopathic treatment protocol.
|
|
| ExclusionCriteria |
| Details |
Pregnant or Breast-feeding female will not participate due to hormonal fluctuations.
Cases with nasal polyp, Sinusitis, Adenoid Hypertrophy will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acute Rhinitis Symptom Score (ARSS) |
Follow up at every 2 weeks and At the End of
treatment as per the requirements of the case |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
S.IgE
ESR |
At Base line & at 12 weeks of treatment as per the requirements of the case |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Allergic rhinitis (AR) is a chronic IgE-mediated hypersensitivity disorder triggered by environmental allergens such as dust, pollen, and animal dander, affecting nearly 20–30% of the Indian population. Despite being non-fatal, AR significantly impairs quality of life through sleep disturbances, fatigue, and reduced productivity. Conventional treatments, including antihistamines and corticosteroids, offer only temporary relief and may cause adverse effects. Homeopathy provides a holistic approach, and Histaminum hydrochloricum, a preparation derived from histamine, has shown promise in allergic conditions but remains under-researched in AR. The present study aims to clinically verify its effectiveness in allergic rhinitis. An interventional, uncontrolled clinical trial will be conducted at Smt. S. I. Patel Homoeopathic Hospital, Anand, over 9 months. Eighty patients will be screened, and 38 eligible participants (aged 10–80 years) will be enrolled using purposive sampling. Treatment will be individualized according to homeopathic principles, with potency adjusted to patient susceptibility. Outcomes will be assessed using Score for Allergic Rhinitis (SFAR), Acute Rhinitis Symptom Score (ARSS), and laboratory parameters (IgE, CBC, AEC) at baseline and follow-up. Data will be analyzed using paired t-test to compare pre- and post-treatment scores. The study seeks to provide systematic clinical evidence on the role of Histaminum hydrochloricum in managing AR, bridging clinical practice with evidence-based validation. |