Homeopathic treatment of sore throat in children

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Individualized homoeopathic medicines in centesimal potencies plus concomitant care: Intervention is planned as administering the indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; doses and repetition depending upon the individual requirement of the cases. Patients will be advised to restrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the patients will receive advice on gargling with luke‐warm saline water. Appropriate homoeopathic remedy or paracetamol will be used as rescue remedy as appropriate. Duration of therapy: 15 days. Control Intervention1: Identical‐looking placebos plus concomitant care: This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; doses and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the patients will receive advice on gargling with luke‐warm saline water. Appropriate homoeopathic remedy or paracetamol will be used as rescue remedy as appropriate. Duration of the therapy: 15 days. CONDITION: Health Condition 1: J038‐ Acute tonsillitis due to other specified organisms PRIMARY OUTCOME: Tonsillo‐pharyngitis assessment (TPA) scoreTimepoint: Baseline, every day, up to 7 days, and 10th and 15th days. SECONDARY OUTCOME: Days to complete recoveryTimepoint: Baseline, every day, up to 7 days, and 10th and 15th days. Days to remission of sore throatTimepoint: Baseline, every day, up to 7 days, and 10th and 15th days. Sore throat pain model (STPM)Timepoint: Baseline, every day, up to 7 days, and 10th and 15th days. INCLUSION CRITERIA: 1.Children suffering from acute sore throat of resent onset (<= 3 days), representing with clinical features of acute vial tonsillitis, scoring >= 5 on tonsillopharyngitis assessment (TPA) and viral aetiology confirmed by RTPCR, and bacterial origin will be excluded by bacterial culture. 2.Participants of either sex. 3.Age between 5 and 15 years. 4.Literate patientâ??s parents; ability to read and write in Bengali and/or English. Illiterate participants will be interviewed by the investigators maintaining adequate privacy to fill up the scale or questionnaires. 5.The parents providing written informed consent voluntarily and the children providing with informed assent.
Epistemonikos ID: 674378fc5d4e89426c601a75938145f63cf24c3f
First added on: Feb 20, 2024