| CTRI Number |
CTRI/2025/08/092643 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess allergic rhinitis using homoeopathic medicines |
|
Scientific Title of Study
|
Effectiveness of Homoeopathic Medicines in LM Potency for Managing Perennial Allergic Rhinitis: A Prospective Study Using RCAT Score |
| 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 Roy Thomas |
| Designation |
Junior Resident |
| Affiliation |
Sarada Krishna Homoeopathic Medical College & Hospital |
| Address |
Dept. of Organon of Medicine SKHMC
Kulasekharam Kanniyakumari District
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
09746571384 |
| Fax |
|
| Email |
roythomascall@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roy Thomas |
| Designation |
Junior Resident |
| Affiliation |
Sarada Krishna Homoeopathic Medical College & Hospital |
| Address |
Dept. of Organon of Medicine SKHMC
Kulasekharam Kanniyakumari District
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
09746571384 |
| Fax |
|
| Email |
roythomascall@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roy Thomas |
| Designation |
Junior Resident |
| Affiliation |
Sarada Krishna Homoeopathic Medical College & Hospital |
| Address |
Dept. of Organon of Medicine SKHMC
Kulasekharam Kanniyakumari District
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
09746571384 |
| Fax |
|
| Email |
roythomascall@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTION - Sarada krishna homoeopathic medical college, Kulasekharam, Kanniyakumari district, Tamilnadu,India 629161 |
|
|
Primary Sponsor
|
| Name |
Post graduate research funded by college. To |
| Address |
Sarada Krishna Homoeopathic Medical College and Hospital, Kanniyakumari district, Tamilnadu 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 MANOJ NARAYAN V |
Sarada Krishna Homoeopathic Medical College |
Room No 403 III floor Department of
Organon,Opd,Ipd,Rural Health Centres, Sarada Krishna Homoeopathic
Medical College,
Kulasekharam,
Kanniyakumari,
TamilNadu,629161. Kanniyakumari
TAMIL NADU
Kanniyakumari
TAMIL NADU |
9995114518
manojnarayanv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHHICAL COMMITTEE SARADA KRISHNA HOMOEOPATHIC MEDICALCOLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J308||Other allergic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines in LM Potency |
Standardized homoeopathic medicines in LM potency through oral route one dose for once in 2 weeks and is followed for a period of 3 months . The medicine is selected based on common clinical indications for perennial allergic rhinitis. Medicines administered in water doses with standardized dispensing protocol. Outcome assessed using RCAT Score. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Acute upper respiratory tract infections.
2. Presence of bronchial asthma or other chronic respiratory illness.
3. Use of anti-allergic or steroidal medications during the study period.
4. Known hypersensitivity to any of the ingredients in the medicine used.
5. Pregnant or lactating women.
6. Patients with serious systemic illness. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from acute upper respiratory tract infections.
2. Patients having bronchial asthma and other chronic respiratory conditions.
3. Patients under anti-allergic treatment.
4. Pregnant and lactating women.
5. Patients with serious systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in RCAT (Rhinitis Control Assessment Test) score. |
Baseline, at 2-week intervals during treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in use of conventional anti-allergic medications. The medicine will be administered orally, one dose, once in 2 weeks for a period of 3 months
|
The assessment will be done at baseline & at 3 months |
| Reduction in use of conventional anti-allergic medications. |
Throughout the treatment period. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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 is a prospective, single-arm, observational study conducted at Sarada Krishna Homoeopathic Medical College and Hospital (SKHMC), Kulasekharam, to evaluate the effectiveness of individualized homoeopathic medicines in LM potency for managing perennial allergic rhinitis using the Rhinitis Control Assessment Test (RCAT) score. Thirty-four pre-diagnosed cases fulfilling the inclusion criteria will be selected purposively from the OPD, IPD, and rural health training centres. Follow-up will be done weekly or biweekly for one year. Outcomes include change in symptom control and reduction in the need for conventional anti-allergic medications. |