CTRI/2014/06/004673

Trial name or title	Double blind, randomised placebo control study to evaluate efficacy and safety of EMTACT, a homeopathic drug in the management of recurrent upper and lower respiratory tract infections
Methods	NB: unpublished trial ‐ all information from clinical trial registry record Randomised, parallel‐group, placebo‐controlled trial of homeopathy for recurrent upper and lower respiratory tract infections Computer‐generated randomisation Method of allocation concealment: central Participant, investigator, and outcome assessor blinded.
Participants	Setting: India. 2 sites of study listed: Bhiwandi Homeopathic Integrated Medical Practitioners (BHIMPA) and Life Force research projects No. of participants: target sample size 150, unclear if this number achieved Recruitment method: not stated Withdrawals and exclusions: not stated Age range: 3 to 70 years Gender: both male and female Eligibility criteria: Inclusion criteria Having episodes of recurrent URTI or LRTI or both, at least 4 times in previous 6 months, for at least 1 day at a time At least 1 symptom from at least 2 of the location group symptoms, such as nasal symptoms (sneezing, running nose, nose block), throat symptoms (sore throat), bronchial symptoms (cough, wheezing), head and sinus symptoms (headache, face‐ache), general symptoms (fever, fatigue, low appetite) Willing to refrain from taking nasal decongestants, antihistamines, or cough/cold preparations, antibiotics, and homeopathic medicines during the trial period, unless symptoms are severe Exclusion criteria Ongoing treatment for tuberculosis or untreated tuberculosis (to rule out by full blood count, ESR, chest X‐ray) Any clinically significant medical condition or abnormality Homeopathic treatment for any chronic disease within 1 month Immunocompromised patient Children who are scheduled to receive any other investigational drug during the course of the study
Interventions	Intervention: homeopathic drug EMTACT, 30c potency, orally 6 pills 3 times a day for 6 months Comparator agent: placebo, size 30 pills, orally 6 pills 3 times a day for 6 months
Outcomes	All evaluated at 6‐month time point. Frequency of attacks: to evaluate the efficacy of potentised preparation EMTACT 30c potency by measuring the reduction in frequency of attacks of recurrent upper and lower respiratory tract infections Improvement in appetite Increase in weight Efficacy in terms of symptoms severity, including nasal symptoms (sneezing, running nose, nose block), throat symptoms (sore throat), bronchial symptoms (cough, wheezing), head and sinus symptoms (headache, face‐ache), general symptoms (fever, fatigue, low appetite), using questionnaire/clinical symptomatic relief from baseline Efficacy in terms of duration of symptoms Evaluation of health economics parameters such as children missing school and adults missing office work due to recurrent upper and lower respiratory tract infections Safety measures (lab parameters complete blood count, ESR, chest X‐ray, urine, renal function, liver function)
Starting date	20 February 2014
Contact information	Dr Rajesh Shah rajesh@askdrshah.com
Notes	Source of monetary or material support: Homeopathy India Private Limited for Life Force research projects