| CTRI Number |
CTRI/2020/08/027386 [Registered on: 26/08/2020] Trial Registered Prospectively |
| Last Modified On: |
24/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study on the immune Enhancing Effect of Nidigdhikadi Leha on Upper Respiratory Tract Infections (URTI) |
|
Scientific Title of Study
|
Clinical Study on the Immunomodulatory Effect of Nidigdhikadi Leha on Pranavaha Srotodushti w.s.r Upper Respiratory Tract Infections in Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amandeep |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Balroga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
P.G. Department of Balroga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058583172 |
| Fax |
|
| Email |
drammmy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha kumari Ojha |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Balroga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
P.G. Department of Balroga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9468650449 |
| Fax |
|
| Email |
drnishaojha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha kumari Ojha |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Balroga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
P.G. Department of Balroga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9468650449 |
| Fax |
|
| Email |
drnishaojha@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIA, Pharmacy, National Institute of Ayurveda, Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Balroga, National Institute of Ayurveda, Jaipur, Rajasthan 302002 |
| 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 |
| Dr Amandeep |
National Institute of Ayurveda Hospital Jaipur |
OPD no-5, Department of Balroga, National Institute of Ayurveda, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
8058583172
drammmy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J399||Disease of upper respiratory tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1) Group A Trail Drug (Nidigdhikadi Leha) |
The proposed Trail Drug in Avleha Form Nidigdhikladi Leha 180-200 mg/Kg/Day Into Two Divided Doses for 8 Weeks.
Route of Administration: Oral,
Time of administration: After breakfast and in evening |
| Comparator Agent |
2)Group B,Honey Drops |
Control Group ( Honey Drops) Prescribe in 1 drops/kg/day into Two Divided Dose for 8 Weeks.
Route of Administration: Oral,
Time of Administration: After breakfast and in evening |
| Comparator Agent |
3) Group C, Sitopaladi Churna |
Conventional treatment (Sitopaladi Churna) Prescribe in 100 mg/Kg/Day into Two Divided Dose for 8 Weeks.
Dosage form: Churna mixed with honey
Route of administration: Oral
Time of administration: After breakfast and in evening |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Children aged between 6 to 12 years of either sex.
2) Children with recurrent upper respiratory infections.
3) Children whose parents are willing to give consent for clinical trail. |
|
| ExclusionCriteria |
| Details |
1) Children suffering from major systemic
illness necessitating hospitalization.
2) Children with evidence of malignancy,
genetic or congenital anomaly.
3) Children with concurrent serious hepatic
dysfunction (defined as AST and/or
ALT>3 times of the upper normal limit)
or renal dysfunction (defined as S.
creatinine>1.2mg/dl) uncontrolled
pulmonary dysfunction (asthmatic and
COPD patients)
4) Chronic illness like TB, UTI and bleeding
disorders etc.
5) H/o hypersensitivity to any of the trial
drug or their ingredients.
6) Children who have completed
participation in any other clinical trial
during the past six months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Morbidity Score |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in episodes of Upper Respiratory Tract Infections |
8 Weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
01/09/2020 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Children have a speedy physical &
psychological changes undergo from birth
through adolescence. The process of child
development can include everything from
sensory awareness & fine motor skills.
Children have a greater variety of acute
chronic problem. Preventable diseases such as
pneumonia, diarrhoea & other infections are
major cause of child’s morbidity so all
children have varying physical and emotional
needs, depending on their age, personality and
developmental stage. The immune system has
involved dealing with infections pathogens.
This refers to the ability of body to defend.
Itself against specific invading agents such as
bacteria, toxins, viruses and foreign body
tissues. The immune system can be broadly
divided into 2 categories, innate and adaptive
immunity. Innate immune cells are found in
relative abundance throughout the body and
include neutrophils, basophils, mast cells,
eosinophils, monocytes, macrophages and
dandritic cells. The adaptive immune system
includes T and B lymphocytes. Typically,
patients who have immune deficiencies in
adaptive immunity in the setting of recurrent
respiratory tract infection have deficiency in
adaptive immunity or dysfunction in either B
or T cells leads to poor antibody production or
quality and subsequent susceptibility to
sinopulmonary infections. Epidemiologist
estimates that 15% of children suffers from
RRTIs, Among the predisposing factors
immune system deficiencies can be considered
as well as anatomic and functional alteration in
the respiratory tract, air pollution exposure or
poor social conditions. RRTI are a common
problem mainly in preschool age, usually due
to unfavourable environmental conditions.
RRTIs initially occur as a viral respiratory tract
infection, but bacterial growth is demonstrated
in 60% of patients with symptoms of an upper
respiratory tract infection of at least 10 days
duration. Therefore with these perspectives the
present trial entitled “Clinical Study on the
Immunomodulatory Effect of Nidigdhikadi
Leha on Pranavaha Srotodushti w.s.r. Upper
Respiratory Tract Infections in Children. |