Health Condition 1: null- Recurrent Upper and Lower Respiratory Tract affections Health Condition 2: J989- Respiratory disorder, unspecified
Conditions
Interventions
Intervention1: Homeopathic drug EMTACT: 30c potency, orally 6 pills 3 times a day for 6 months
Control Intervention1: Placebo: size 30 pills, orally 6 pills 3 times a day for 6 months
Sponsors
Homeopathy India Private Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Rajesh Shah
Life Force Research Projects
Outcome results
None listed