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CTRI Number  CTRI/2014/06/004673 [Registered on: 13/06/2014] Trial Registered Retrospectively
Last Modified On: 21/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effects of Homeopathic drug EMTACT in patients with Recurrent Upper and Lower Respiratory Tract affections. 
Scientific Title of Study   Double blind, randomized placebo control study to evaluate efficacy and safety of EMTACT, a Homeopathic drug in the management of Recurrent Upper and Lower Respiratory Tract affections 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajesh Shah 
Designation  Principal Investigator 
Affiliation  Life Force Research Projects 
Address  Life Force Research Projects 411 Krushal Commercial Complex Chembur Mumbai 400089 India

Mumbai
MAHARASHTRA
400089
India 
Phone  912266888888  
Fax  912267031855  
Email  rajesh@askdrshah.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Shah 
Designation  Principal Investigator 
Affiliation  Life Force Research Projects 
Address  Life Force Research Projects 411 Krushal Commercial Complex Chembur Mumbai 400089 India

Mumbai
MAHARASHTRA
400089
India 
Phone  912266888888  
Fax  912267031855  
Email  rajesh@askdrshah.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Shah 
Designation  Principal Investigator 
Affiliation  Life Force Research Projects 
Address  Life Force Research Projects 411 Krushal Commercial Complex Chembur Mumbai 400089 India

Mumbai
MAHARASHTRA
400089
India 
Phone  912266888888  
Fax  912267031855  
Email  rajesh@askdrshah.com  
 
Source of Monetary or Material Support  
Homeopathy India Private Limited for Life Force Research projects 
 
Primary Sponsor  
Name  Homeopathy India Private Limited 
Address  412 Krushal Commercial Complex Chembur Mumbai 400089 India Phone: 912266888888 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arjun Singh Shah  Bhiwandi Homeopathic Integrated Medical Practitioners (BHIMPA)  Bhiwandi Homeopathic Integrated Medical Practitioners BHIMPA Shop No 3 Above Snehanjali Showroom Opp Danderkar Company Kalyan Road Bhiwandi Dist Thane 421302
Thane
MAHARASHTRA 
09321657474

dr.arjunsingh@rediffmail.com 
Dr Rajesh Shah  Life ForceResearch Projects  411 Krushal Commercial Complex Chembur Mumbai 400089 India
Mumbai
MAHARASHTRA 
912266888888
912267031855
rajesh@askdrshah.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Homeopathy India Pvt Ltd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Recurrent Upper and Lower Respiratory Tract affections, (1) ICD-10 Condition: J989||Respiratory disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
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  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="148" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/02/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Published in peer review journal. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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.

A double-blind, randomized placebo-controlled trial was performed in 148 patients (age: ≥ 3 to ≤ 70 years old) at two sites. There was a significant gain in weight, improvement in sleep, mood and school performance in the patients administered with Emtact 30C. Continuous nose block, cough/expectoration and watery nasal discharge was also reduced in the Emtact arm. 


 
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