| 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
|
|
|
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
|
|
|
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
|
|
|
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. |