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CTRI Number  CTRI/2018/03/012613 [Registered on: 16/03/2018] Trial Registered Prospectively
Last Modified On: 16/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Homoeopathic treatment of cough and cold in children 
Scientific Title of Study   Effectiveness of individualized homoeopathic medicines vs. Sabadilla in the treatment of upper respiratory tract infections in children: An open-label randomized pragmatic clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1210-9151  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nisha Sehrawat 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  Department of Paediatrics, OPD room no. 8, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  8826440797  
Fax    
Email  drnisha0797@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gautam Ash 
Designation  Professor and Head 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  Dept of Paediatrics, OPD room no. 8, Block GE, Sector III, Salt Lake, Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone    
Fax    
Email  dr.gautam.ash01@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gautam Ash 
Designation  Professor and Head 
Affiliation  National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India 
Address  Dept of Paediatrics, OPD room no. 8, Block GE, Sector III, Salt Lake, Kolkata


WEST BENGAL
700106
India 
Phone    
Fax    
Email  dr.gautam.ash01@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  National Institute of Homoeopathy Ministry of AYUSH Govt of India 
Address  Block GE, Sector III, Salt Lake, Kolkata, West Bengal 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nisha Sehrawat  National Institute of Homoeopathy, Govt. of India  Dept of Paediatrics, OPD room no. 8, Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL 
8826440797

drnisha0797@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Children with upper respiratory tract infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Individualized homoeopathic medicines in centesimal or 50 millesimal potencies  In centesimal scale, each dose consist of a single drop of the indicated medicine (preserved in 90% v/v ethanol) in 5 ml of distilled water, to be taken orally; dosage and repetition depending upon the individual requirement of the cases. In 50 millesimal scale, a single medicated cane sugar globule of poppy seed size (no. 10) will be dissolved in 90 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Medicines to be taken orally on clean tongue in empty stomach. Duration of therapy: 15-17 days 
Intervention  Sabadilla in centesimal or 50 millesimal potencies  In centesimal scale, each dose consist of a single drop of Sabadilla (preserved in 90% v/v ethanol) in 5 ml of distilled water, to be taken orally; dosage and repetition depending upon the individual requirement of the cases. In 50 millesimal scale, a single medicated cane sugar globule of poppy seed size (no. 10) will be dissolved in 90 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Medicines to be taken orally on clean tongue in empty stomach. Duration of therapy: 15-17 days 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  1. Preadolescent children (1-11 years of age)
2. Clinical signs and symptoms of an URTI with a duration of up to 24 hours accompanied with or without fever 37.5áµ’C (axillary body temperature) or higher
3. At least 1 of 3 types of URTI symptoms – Nasal (plugged nose, runny nose, sneezing), Pharyngeal (scratchy throat, sore throat, pharyngeal hyperaemia), Cough (ordinary cough without suspicion of acute lower respiratory tract disease).
4. At least 1 of 5 general symptoms – feeling tired, weakness, body ache, irritable or whiney, or less active 
 
ExclusionCriteria 
Details  1. Severe or complicated course of URTI.
2. Signs of acute lower respiratory tract disease.
3. Current symptoms mainly induced by other acute ENT diseases.
4. Daily use of antibiotics, steroids and cytotoxic agents.
5. Children on active treatment from any other system of medicine.
6. Children with any uncontrolled systemic disease, infection, and any organ failure.
7. Severe co morbidity including previous malignant disease during the past 5 years prior enrolment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Wisconsin Upper Respiratory Symptom Survey (WURSS-21); translated Bengali version  Baseline, 4 (±1) days, 8(±1) days, and 15(±2) days after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Canadian Acute Respiratory Illness and Flu Scale (CARIFS-18); translated Bengali version  Baseline, 4 (±1) days, 8(±1) days, and 15(±2) days after treatment 
Symptom Score for RTI (SSRTI); translated Bengali version  Baseline, 4 (±1) days, 8(±1) days, and 15(±2) days after treatment 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   19/03/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet; to be published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Upper respiratory tract infection include various infections affecting the different parts of upper respiratory tract which mainly includes acute pharyngitis, acute rhinitis, acute sinusitis, acute tonsillitis, and acute otitis media also come under umbrella of URTI. Colds are responsible for significant morbidity: on average there are 0.4 episodes and 1.2 days for restricted activity per person per year for the common cold. In developing countries, overcrowded dwellings, poor nutrition low birth weight and intense indoor smoke pollution underline the high rates. A recent National Family Health Survey (NFHS-3) data suggests a 5.8% prevalence rate of ARI. Approximately 75% of antibiotics are prescribed for ARI, and many of these prescriptions are unnecessary. This unwarranted use of antibiotics is not only very expensive but has also contributed to rapid increase in antimicrobial resistance to bacteria causing respiratory infections. In few randomized trials, homoeopathy produced significantly different effect beyond placebo. Under such circumstances URTI in pediatric age group become a promising research area in homoeopathy.  In this open, randomized, pragmatic clinical trial at National Institute of Homoeopathy, 100 children suffering from URTI will be randomized to either treatment by empirically selected Sabadilla (verum; n=50) or individualized homoeopathic treatment (control; n=50) to examine whether there are any differences in outcomes between these two groups over 15-17 days of intervention. Translated Bengali version of the WURSS-21 questionnaire, CARIFS-18, and symptom score for RTI will be used as outcome measures. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.

 
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