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
|
|
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
|
|
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.
|