| CTRI Number |
CTRI/2018/06/014419 [Registered on: 05/06/2018] Trial Registered Prospectively |
| Last Modified On: |
04/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ROLE OF SYRUP "DURALABHADI YOG" IN THE MANAGEMENT OF COUGH IN CHILDREN |
|
Scientific Title of Study
|
"A Clinical Study to Evaluate the role of Duralabhadi yog in the Management of Kasa 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 PRIYANKA KANAUJIA |
| Designation |
PG SCHOLAR |
| Affiliation |
STATE AYURVEDIC COLLEGE AND HOSPITAL LUCKNOW,U.P. |
| Address |
P.G. DEPARTMENT OF KAUMARABHRITYA STATE AYURVEDIC HOSPITAL TUDIYAGANJ LUCKNOW,U.P.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8115184738 |
| Fax |
|
| Email |
pasmile888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAMESH KUMAR GAUTAM |
| Designation |
LECTURER |
| Affiliation |
STATE AYURVEDIC COLLEGE AND HOSPITAL LUCKNOW,U.P. |
| Address |
P.G. DEPARTMENT OF KAUMARABHRITYA STATE AYURVEDIC HOSPITAL TUDIYAGANJ LUCKNOW,U.P.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9450361310 |
| Fax |
|
| Email |
gautamramesh09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAMESH KUMAR GAUTAM |
| Designation |
LECTURER |
| Affiliation |
STATE AYURVEDIC COLLEGE AND HOSPITAL LUCKNOW,U.P. |
| Address |
P.G. DEPARTMENT OF KAUMARABHRITYA STATE AYURVEDIC COLLEGE TUDIYAGANJ LUCKNOW,U.P.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9450361310 |
| Fax |
|
| Email |
gautamramesh09@gmail.com |
|
|
Source of Monetary or Material Support
|
| STATE AYURVEDIC COLLEGE AND HOSPITAL LUCKNOW AND LUCKNOW UNIVERSITY UTTAR PRADESH |
|
|
Primary Sponsor
|
| Name |
STATE AYURVEDIC COLLEGE AND HOSPITAL LUCKNOWUP |
| Address |
STATE AYURVEDIC COLLEGE AND HOSPITAL TUDIYAGANJ LUCKNOW,U.P. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SELF |
DR.PRIYANKA KANAUJIA PG.SCOLAR DEPTT OF KAUMARABHRITYA STATE AYURVEDIC COLLEGE AND HOSPITAL TUDIYAGANJ LUCKNOW,U.P. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka kanaujia |
State Ayurvedic College and Hospital Lucknow Uttar Pradesh |
OPD no.2 Deptt of Kaumarabhritya
Lucknow
UTTAR PRADESH |
8115184738
pasmile888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State Ayurvedic College and Hospital,Lucknow |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient suffering from Kasa with in 15 days , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable because single arm trail |
not applicable |
| Intervention |
Syrup Duralabhadi Yoga |
Administered orally in dose of 1ml/kg body wt/day in three divided dosage for 12 day |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patient with sign and symptoms of kasa vadhi which are mentioned in Ayurvedic text book. |
|
| ExclusionCriteria |
| Details |
1.children above the age 10 year and below 5 year.
2. Kasa associated with complication.
3. Kshayaja Kasa and Kshataja kasa.
4. Children suffering from systemic disorder and congenital anomalies & genetic disorder.
5.Children suffering from Pneumonia, COPD, Emphysema, Diphtheria, Pertussis & secondary infection of Respiratory system & cardiac disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in cough |
3 to 5 day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in loss of appetite,nausea
Hoarseness of voice
|
3-5 day
2-3 day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
11/06/2018 |
| 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) |
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
|
It is a single arm trial to evaluate the efficacy the role of Duralabhadi Yog in the Management of Kasa in Children on scientific parameter : the study is aimed to conduct on 30 patients from OPD and IPD of State Ayurvedic and Hospital Lucknow (U.P.).Study include children aged between 5 to 10 years. The trial drug will be administered as syrup from in the dose of 1ml/kg body wt/day in 3 divided dosage for 12 days. The follow up will be done on 3rd day, on 5th day, on 12th day. The documented observations and findings of study will be assessed by using statistical analysis to set up the efficacy of trial drug. |