| CTRI Number |
CTRI/2025/08/093509 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of Homoeopathic remedy Arsenicum iodatum for Allergy related sneezing and running nose in children |
|
Scientific Title of Study
|
A controlled clinical study on the effectiveness of Arsenicum iodatum in LM potency in managing Allergic Rhinitis among Paediatric age group |
| 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 Geo Paul |
| Designation |
Post Graduate Student |
| Affiliation |
Sarada Krishna Homoepathic Medical College |
| Address |
Room number 409,third floor, college building, Department of Paediatrics, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9562761190 |
| Fax |
|
| Email |
geokonnanal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P R Sisir |
| Designation |
Professor and Head |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room number 409,third floor, college building, Department of Paediatrics, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443474941 |
| Fax |
|
| Email |
hodpd@skhmc.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr P R Sisir |
| Designation |
Professor and Head |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Room number 409,third floor, college building, Department of Paediatrics, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443474941 |
| Fax |
|
| Email |
hodpd@skhmc.org |
|
|
Source of Monetary or Material Support
|
| INSTITUTION- Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic Medical College |
| Address |
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari ,Tamil Nadu, India , 629161 |
| 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 Geo Paul |
Sarada Krishna Homoeopathic Medical College Hospital |
Room no. 108, Outpatient Department of Paediatrics, Sarada Krishna Homoeopathic Medical College and Hospital, Kulasekharam, Kanniyakumari , Tamil Nadu, 629161
Kanniyakumari
TAMIL NADU |
9562761190
geokonnanal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution of Ethics Committee,Sarada Krishna Homoeopathic Medical College |
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 |
Arsenicum iodatum in 50 millesimal scale potency |
Potency- 50 Millesimal potency for 2 months
Dose - Homoeopathic medicines will be administered orally according
to the susceptiblity of the patient.
Repetition of medicine will be decided based on the improvement of the patient. |
| Comparator Agent |
Natrum sulphuricum 6X |
Potency- 6X
Dose - 2 Tablet twice a day (2 x BID) for 2 months
Repetition of medicine will be decided based on the improvement of the patient. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children and adolescents aged between 2 and 18 years
Both male and female participants
Diagnosis primarily determined by clinical symptoms
Individuals experiencing repeated episodes of allergic rhinitis
Evaluation of improvement based on the reduction of symptoms
|
|
| ExclusionCriteria |
| Details |
Patients with additional respiratory disorders or associated complications.
Patients suffering from other severe systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in the symptom severity assessed using the Total Nasal Symptom Severity (TNSS) Score in the intervention group compared to the baseline. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disappearance of symptoms will be noted. |
2 months |
| General Improvement of the patient will be noted |
2 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
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2025 |
| 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 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
|
Randomised controlled trial in which 60 cases of patients within the age group 2 years to 18 years presenting with symptoms of Allergic rhinitis from the OPD, IPD, rural centers, School health awareness programmes of Sarada Krishna Homoeopathic Medical College will be evaluated. Study will be based on analysing the effectiveness of Arsenicum iodatum in fifty millesimal potencies in treatment of allergic rhinitis among paediatric age group. The case details will be recorded in standardized and pre-structured case format of Sarada Krishna Homoeopathic Medical College and will be analyzed using total nasal symptom severity score scale at the baseline and then the totality will be erected and then the medicine will be administered orally. The patients will be divided randomly into two groups, intervention group of 30 cases prescribed with Arsenicum iodatum in fifty millesimal potencies and a control group of 30 cases prescribed with Natrum sulphuricum 6X respectively and will be analysed sing total nasal symptom severity score scale at the baseline and will be analysed for every two weeks for a period of 2 months. Thus to understand the significant reduction in the symptom severity in the intervention group in order to study the effectiveness of Arsenicum iodatum in treating allergic rhinitis among paediatric age group. |