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

Phase 3

Completed

Brief Summary: This study is a randomized, double blind, placebo controlled, multi-centre trial evaluating the efficacy and safety of EMTACT 30c daily and Placebo daily for 6 months in 150 patients with Recurrent Upper and Lower Respiratory Tract Infections that will be conducted in two centers in India.

The primary outcome measures will be 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 Infections.

The secondary outcomes will be effect on general health in terms of weight gain, improvement in appetite, to evaluate efficacy in terms of symptoms severity and duration.

Adouble-blind, randomized placebo-controlled trial was performed in 148 patients(age: â‰¥ 3 to â‰¤ 70 years old) at twosites. There was asignificant gain in weight, improvement in sleep, mood and school performancein the patients administered with Emtact 30C. Continuousnose block, cough/expectoration and watery nasal discharge was also reduced inthe Emtact arm.

Recruitment & Eligibility

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.

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 Infections	6 months

Secondary Outcome Measures

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

Locations (2): Bhiwandi Homeopathic Integrated Medical Practitioners (BHIMPA)
🇮🇳
Thane, MAHARASHTRA, India
Life ForceResearch Projects
🇮🇳
Mumbai, MAHARASHTRA, India
Bhiwandi Homeopathic Integrated Medical Practitioners (BHIMPA)
🇮🇳Thane, MAHARASHTRA, India
Dr Arjun Singh Shah
Principal investigator
09321657474
dr.arjunsingh@rediffmail.com