| CTRI Number |
CTRI/2020/03/023977 [Registered on: 16/03/2020] Trial Registered Prospectively |
| Last Modified On: |
14/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of kinshukkshar siddha pippali churna and Guduchi churna on rate of illness (morbidity status) of respiratory system in preschool children. |
|
Scientific Title of Study
|
A randomized comparative clinical study to evaluate the efficacy of kinshukkshar siddha pippali churna with Guduchi churna on morbidity status of respiratory system in preschool 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 Sameer Suresh Muratkar |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9403238377 |
| Fax |
|
| Email |
sameermuratkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9975404439 |
| Fax |
|
| Email |
drsudha2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameer Suresh Muratkar |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9403238377 |
| Fax |
|
| Email |
sameermuratkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurved and research center, Kaumarbhritya department, Sector no. 25 Pradhikaran Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
Principal PDEAs College of Ayurved and Research center |
| Address |
PDEAs College of Ayurved and Research center, Nigdi, Pradhikaran,
Sector 25, pune 44 |
| Type of Sponsor |
Private 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 Sameer Suresh Muratkar |
Ayurveda Rungalay And Sterling Multispeciality Hospital Nigdi |
Vitthal Rukmini road,
Sector No 27, Nigdi
Pradhikaran, pune
411044, Name of
OPD-Kaumarbhritya,
OPD No. 118, Ground
floor, Pune
Pune
MAHARASHTRA |
9403235377
sameermuratkar@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 |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Guduchi churna |
Guduchi churna will be prepared will be given orally with Madhu after meal twice a day includes follow up on after 7th, 15th,30th ,60th and 90th days. |
| Intervention |
kinshukkshar siddha pippali churna |
kinshukkshar siddha pippali churna will be prepared as a rasayan and will be given orally with
Madhu after meal twice
a day includes follow up on
after 7th, 15th,30th ,60th and 90th days. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Patient between the age group of 3 to 6 years irrespective of gender.
Having symptoms of respiratory system infection like Running nose ,Cough, Hiccugh, Fever, Sore throat , Horseness of voice etc.
History of sickness of respiratory system at least once in a month.
|
|
| ExclusionCriteria |
| Details |
• Respiratory distress with high fever (≥101ºf)
• Known case of chronic respiratory diseases like tuberculosis.
• Known case of congenital anomaly like trachea oesophageal fistula, cystic fibrosis.
• Patient on some other long term medication
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate efficacy of kinshukkshar siddha pippali churna will be given orally with Madhu after meal twice a day is as
effective as Guduchi churna will be given orally with Madhu after meal twice a day on morbidity status of respiratory system in preschool children for 90 days. |
90 days with follow up on 7th, 15th, 30th, 60th, 90th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the adverse effect if any.
To compare efficacy of kinshukkshar siddha pippali churna.
To compare efficacy of Guduchi churna. |
90 days with follow up on 7th, 15th, 30th, 60th, 90th day. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/03/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Etiology of childhood morbidity and mortality varies with age and may be divided into two major groups-endogenous causes, e.g. low birth weight, predominantly responsible for neonatal morbidity and exogenous causes, e.g. infections and malnutrition, which usually affect beyond the neonatal period. Acute respiratory infections are major cause of morbidity and mortality in children and of particular significance in developing countries like India. Outpatient attendance attributed to acute respiratory infections is as high as 20-40%.
The morbid conditions are more prevalent in the urbanized children who are exposed to various risk factors like overcrowding, poor nutrition due to junk food and ready to cook food etc. The morbidity patterns among under-five’s will be of use in assessing the overall impact of improved nutritional and immunization status as a result of various ongoing nutritional improvement and disease control programs as well as in planning resource allocations at the national level . Hence an attempt has been made in this study to look for the patterns of morbidity status of respiratory system in preschool children. |