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 Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- Time (Day) to complete resolution of symptoms of URTI.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 10.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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).
- •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.
Exclusion Criteria
- •Not providing written assent or consent of participation.
- •Progress to lower respiratory tract infection and Severe or complicated course of URTI—e.g., bronchitis, pneumonia etc.
- •Severe concomitant diseases (renal failure, heart anomalies, circulatory failure, cardiomyopathy, decompensated kidney and liver, immunosuppressive conditions, and oncological diseases).
- •Known or suspected hypersensitivity to any component of the study medication 5) Use of immunomodulatory medications.
- •Being vaccinated against influenza within the last 6 months before the start of the study.
- •Vulnerable population—unconscious, non-ambulatory, too sick for consultation, differently abled, or terminally or critically ill.
- •Subjects undergoing homeopathic treatment for any chronic disease(s) within last 15 days 9) Simultaneous participation in any other clinical trial.
- •History of atopy & allergy 11) Fever more than 105 degree F 12) Oxygen saturation level below 90 percent.
Outcomes
Primary Outcomes
Time (Day) to complete resolution of symptoms of URTI.
Time Frame: 15 days of intervention
Secondary Outcomes
- 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.)
Investigators
Aradhana Gupta
D N De Homoeopathic Medical College and Hospital