| CTRI Number |
CTRI/2025/08/093341 [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, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines for patients with plugged nose, runny nose, sneezing, coryza, cough, scratchy throat, sore throat, pharyngeal redness |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in the treatment of upper respiratory tract infection in adolescents and adults: A double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1326-8881 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aradhana Gupta |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Repertory, Room no 2 (Peadiatrics) and PG 3 OPD, 12, Gobinda Khatick Road, Kolkata, WEST BENGAL 700046, India
Kolkata
WEST BENGAL
700046
India |
| Phone |
7449886701 |
| Fax |
|
| Email |
dr.aradhanagupta95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aradhana Gupta |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Repertory, Room no 2 (Peadiatrics) and PG 3 OPD, 12, Gobinda Khatick Road, Kolkata, WEST BENGAL 700046, India
Kolkata
WEST BENGAL
700046
India |
| Phone |
7449886701 |
| Fax |
|
| Email |
dr.aradhanagupta95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjib Sarkar |
| Designation |
Reader and Head, Department of Anatomy |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
OPD no. 1 (Medicine), OPD no. 2 (Paediatrics) and PG 3, 12, Gobinda Khatick Road, Kolkata, WEST BENGAL 700046, India
Kolkata
WEST BENGAL
700046
India |
| Phone |
9903701819 |
| Fax |
|
| Email |
sanjibsarkar1102@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata 700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Kolkata 700046, West Bengal |
| Type of Sponsor |
Government 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 Aradhana Gupta |
D N De Homoeopathic Medical College and Hospital |
Room no. 2 (Pediatrics OPD) and PG 3 OPD, 12, Gobinda Khatick Road, Kolkata 700046, West Bengal
Kolkata
WEST BENGAL |
7449886701
dr.aradhanagupta95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J06||Acute upper respiratory infectionsof multiple and unspecified sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-Looking Placebo Concomitant care |
This arm will receive placebo, indistinguishable in appearance from
verum. Each dose of placebo shall consist of 4 globules (no. 40) of cane sugar, moistened
with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and
repetition depending upon the individual requirement of the cases Management guidelines
will be given as in the experimental arm. Concomitant care: Subject will be advised to use face or nasal mask, environmental decontamination, and hand washing. • Diet: Subject will be advised to take green vegetables , whole dairy products and food rich in vitamin C vapor treatment [For 20 minutes, patients received heated vapor treatments.
Duration of therapy: 15 days. |
| Intervention |
Individualized Homoeopathic Medicines with Concomitant care |
Intervention is planned as administering the indicated homeopathic medicine in the desired dosage in centesimal potency as per the need of the case. Each dose of centesimal scale will consist of four cane sugar globules no. 40, medicated with the indicated medicine (preserved in 90% v/v ethanol), which will be taken orally on a clean tongue and with an empty stomach. Patients will be advised to refrain from eating, drinking, or brushing their teeth within 30 minutes of taking the globules and will be asked
to suck the globules rather than simply swallowing those. The dosage and repetition
regimens will be decided by individual requirement of the cases. The duration of therapy
for each patient will be 15 days. All medicines will be procured from a Good
Manufacturing Practice (GMP)-certified firm, Cases will be repertorized with the help of
appropriate repertories and software. The final selection of the single individualized
medicine and dosage will be made following standard homeopathic guidelines The
prescriptions on follow-up visits will be generated as per relevant homeopathic principles and will be recorded in follow-up sheets. Homeopathic remedies or dosage will be allowed to change during the study as and when required, in adherence with homeopathic principles
Concomitant care: Subject will be advised to use face or nasal mask, environmental
decontamination, and hand washing.
• Diet: Subject will be advised to take green vegetables
, whole dairy products and food
rich in vitamin C
vapor treatment [For 20 minutes, patients received heated vapor treatments
Duration of therapy: 15 days. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Adolescent age group (10 to 19 years) and Adult (19 to 60) age group
2) Either sex group or transgender
3) Clinical signs and symptoms of an URTI with a duration of greater than 24 hours with or without a fever greater than 37.5 degrees Celsius (axillary body temperature).
4) At least 1 of 3 types of URTI symptoms—nasal (plugged nose, runny nose, sneezing), pharyngeal (scratchy throat, sore throat, pharyngeal hyperaemia), and cough (ordinary cough without suspicion of acute lower respiratory tract disease)
5) At least 1 of 5 general symptoms—feeling tired, weakness, body ache, irritable or whining, or less active
|
|
| ExclusionCriteria |
| Details |
1) Not providing written assent or consent of participation.
2) Progress to lower respiratory tract infection and Severe or complicated course of URTI—e.g., bronchitis, pneumonia etc.
3) Severe concomitant diseases (renal failure, heart anomalies, circulatory failure, cardiomyopathy, decompensated kidney and liver, immunosuppressive conditions, and oncological diseases).
4) Known or suspected hypersensitivity to any component of the study medication
5) Use of immunomodulatory medications.
6) Being vaccinated against influenza within the last 6 months before the start of the study.
7) Vulnerable population—unconscious, non-ambulatory, too sick for consultation, differently abled, or terminally or critically ill.
8) Subjects undergoing homeopathic treatment for any chronic disease(s) within
last 15 days
9) Simultaneous participation in any other clinical trial.
10) History of atopy & allergy
11) Fever more than 105 degree F
12) Oxygen saturation level below 90 percent
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time (Day) to complete resolution of symptoms of URTI. |
15 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Canadian Acute Respiratory Illness and Flu Scale (CARIFS) |
Baseline and at days 1, 2, 3, 5, 7, 10, and 15 of intervention. |
| Wisconsin Upper Respiratory Symptom Survey (WURSS-21) |
Baseline and at days 1, 2, 3, 5, 7, 10, and 15 of intervention. |
| Complete blood count (CBC) |
At baseline and after 15 days of intervention. |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
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)
|
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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.aradhanagupta95@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In 2021, there were 12.8 billion URTIs worldwide (not including COVID-19) across all age groups, with an incidence rate of 162,484 per 100,000 people. Acute respiratory infections (ARIs), especially upper respiratory tract infections (URTIs), are a leading cause of illness, particularly in developing countries like India. URTIs account for up to 87.5% of all respiratory infections in children and adults and are mostly viral, self-limiting, and treated symptomatically. Despite antibiotics often being prescribed, they are usually unnecessary. Homeopathy is increasingly used for adolescents and adults in URTIs worldwide, particularly in countries like Germany, the UK, and Canada, with many parents favoring it based on personal or peer experiences. While some studies suggest homeopathy may help treat URTIs, high-quality evidence is lacking. This study aims to evaluate the efficacy of individualized homeopathic medicines (IHMs) compared to placebo in treating adolescents and adults URTI using validated tools (WURSS-21, CARIFS) over a 15-day period. The study will also identify commonly prescribed remedies and monitor for any adverse events. |