| CTRI Number |
CTRI/2019/06/019686 [Registered on: 14/06/2019] Trial Registered Prospectively |
| Last Modified On: |
01/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of Amalakyadi Rasayan in reducing the frequency of illness in children by improving the immunity and increasing the body strength |
|
Scientific Title of Study
|
Clinical study on the immune enhancing effect of Amalakyadi Rasayan 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 |
Ajay Kushwaha |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur, Rajasthan |
| Address |
PG Dept.of Balroga, National Institute of Ayurveda Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9454453924 |
| Fax |
|
| Email |
drajayr1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Ojha |
| Designation |
M.D. (Ay.) Ph.D(Ayu.), PDCR, Bsc. Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur, Rajasthan |
| Address |
PG Dept.of Balroga, National Institute of Ayurveda Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9468650449 |
| Fax |
|
| Email |
drnishaojha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Ojha |
| Designation |
M.D. (Ay.) Ph.D(Ayu.), PDCR, Bsc. Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur, Rajasthan |
| Address |
PG Dept.of Balroga, National Institute of Ayurveda Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9468650449 |
| Fax |
|
| Email |
drnishaojha@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Pharmacy department Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
PG Dept.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 |
| Ajay Kushwaha |
National Institute of Ayurveda Hospital Jaipur |
Balroga Department, OPD-5
Jaipur
RAJASTHAN |
9454453924
drajayr1993@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: J30-J39||Other diseases of upper respiratory tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Trial drug (Amalakyadi Rasayana) |
The proposed trial drug Amalakyadi Rasayana will be prescribed in doses according to body weight of children (180 to200 mg/kg/day) for 12 weeks-OD (once in a day) |
| Comparator Agent |
Group B: Control (Sugar syrup) |
Placebo: 1ml/kg/day for 12 weeks-OD (once in a day) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged from 1-10 years of either sex.
2.Children with recurrent respiratory infections.
|
|
| ExclusionCriteria |
| Details |
1.Subjects suffering from major systemic illness necessitating long term treatment
2.Subjects with evidence of malignancy
3.Subjects 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.Co-morbidity like TB, UTI and bleeding disorders etc
5.H/o hypersensitivity to any of the trial drug or their ingredients
6.Subjects 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
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To decrease the morbidity status in children with trial drug.
|
84 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the immune enhancing effect of Amalakyadi Rasayan |
84 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/06/2019 |
| Date of Study Completion (India) |
25/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Preventable infections constitute the major
cause of morbidity in children and constitute far reaching consequences on the
overall development of a child. Frequent infections and illnesses in children
may result in severe limitations in their development and therefore they remain
deprived of many of their opportunities during their childhood.
Although substantial progress has been made
in the field of child health care including vaccinations, nutrition etc, many
of the problems remain to be resolved. The most important one are preventive
childhood infectious diseases which are the leading cause of childhood
morbidity. The major diseases affecting pediatric age group are mostly acute
diarrheal diseases, acute respiratory infections, skin diseases, ear discharges
ect. Although vaccines are there to prevent some of the infectious diseases and
are successful in eradication of some like polio and measles, yet there are
diseases for which vaccines are not available and is dreaded life threatening
in children. Pneumonia, diarrhea and malaria account for 41% of annual death
globally Each year, approximately 20,000 children < 5years are hospitalized
because of influenza complications. In India, study indicates that, major
morbidities in children are- diarrhea (26%), acute respiratory infections
(24.5%) and fever (16.7%)Another study reported that Diarrhea (47.9%) followed by ARI (22.21%), Pica (13%) and Worm
Infestation (9.21%) were the commonest morbidities in children.
The statistics show that children are more
vulnerable to infection because their immune system is less or under developed.
Immune system continues to develop as the infant grows. During this period
attempt should be done to prevention of disease and to enhance physical, mental
and social wellbeing of children so that each child may achieve the genetic
potential with which she/he born.There are lots of references regarding the use
of lehana and rasayana drugs for protecting the children from various
infectious diseases, enhancing their bala (immunity) and for their proper
growth and development of the child.Amalakyadi Rasayana described by
Yogratnakar, Rasayanaadhikar/17 is said to have property of increasing Bala
(strength/ immunity).
Therefore, the present study “Clinical Study
on the Immune Enhancing Effect of Amalakyadi Rasayan in Children has been
undertaken with the following objectives:
1.
To
observe the immune enhancing effect of Amalakyadi
Rasayana
2.
To
reduce the morbidity rate in children with trial drug |