A clinical trial to study the effects of Homeopathic drug EMTACT in patients with Recurrent Upper and Lower Respiratory Tract affections.

Phase 3

Completed

• Conditions: Health Condition 1: null- Recurrent Upper and Lower Respiratory Tract affectionsHealth Condition 2: J989- Respiratory disorder, unspecified

• Registration Number: CTRI/2014/06/004673
• Lead Sponsor: Homeopathy India Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 148

Inclusion Criteria

Having episodes of Recurrent Upper and/or Lower Respiratory Tract affections at least four times in previous six months, for at least for one day at a time.

At least one symptom from at least two 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)

Be willing to refrain from taking nasal decongestants, antihistamines or cough/cold preparations, antibiotics and homeopathic medicines during the trial period, unless symptoms are severe (define).

Written informed consent by patient, by child (assent form) and guardians of patient has been informed about the study and has given her/his written informed consent.

In the opinion of the investigator, able to comply with the requirements of the protocol

Exclusion Criteria

Ongoing treatment for tuberculosis or untreated tuberculosis (to rule out by CBC, ESR, x-ray chest)

Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.

Homeopathic treatment for any chronic disease within l month.

Immuno-compromised patient(Known cases of Tuberculosis, HIV, Cancer)

Females who are pregnant or planning to become pregnant or lactating mother.

Patients who are scheduled to receive any other investigational drug during the course of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of potentized preparation EMTACT 30C potency by measuring the reduction in frequency of attacks of Recurrent Upper and Lower Respiratory Tract InfectionsTimepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
Efficacy in terms of Duration of the symptomsTimepoint: 6 months;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 baselineTimepoint: 6 months;Evaluation of health economics parameters such as children missing their school and adults office work due to Recurrent URTI and LRTI affectionsTimepoint: 6 months;Few immunological parameters may be investigated in a group of patients and the details will be documented appropriatelyTimepoint: 6 months;Improvement in appetiteTimepoint: 6 months;Increase in weightTimepoint: 6 months;Safety measures (lab parameters)(CBC, ESR, X-ray chest, urine, renal functions, liver functions).Timepoint: 6 months