| CTRI Number |
CTRI/2016/05/006972 [Registered on: 31/05/2016] Trial Registered Retrospectively |
| Last Modified On: |
28/05/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“CLINICAL EVALUATION OF VELAI KUDINEER FOR SUZHI MANTHAM (CHILDHOOD ASTHMA) IN CHILDREN†|
|
Scientific Title of Study
|
Clinical evaluation of Velai Kudineer for Suzhi mantham (childhood asthma) 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 |
SKowsalya |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of kuzhandhai maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Department of kuzhandhai maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9698906214 |
| Fax |
|
| Email |
saikowsi27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfSDrTkalyana sundaram |
| Designation |
Head of the department |
| Affiliation |
National Institute of Siddha |
| Address |
Department of kuzhandhai maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Department of kuzhandhai maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9444946270 |
| Fax |
|
| Email |
kalyas53@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKSuresh |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
Department of kuzhandhai maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Department of kuzhandhai maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
|
| Email |
drsureshherbal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidass pandithar Hospital
National Institute of Siddha
Tambaram sanatorium
Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSKowsalya |
National Institute of Siddha |
Ayothidass pandithar Hospital
National Institute of Siddha
Tambaram sanatorium
Chennai
Chennai
TAMIL NADU |
9698906214
saikowsi27@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 |
Fever
Wheezing, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Velai Kudineer |
oral administration 10ml b.d. for 5 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
wheezing
intermittent fever |
|
| ExclusionCriteria |
| Details |
Pneumonia
primary complex |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieving from the symptoms |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| therapeutic efficacy of the trial drugs |
1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
04/09/2015 |
| 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
|
After the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The trial drug “VELAI KUDINEER†is given for 5 days. it contains Velai ver(Cleome viscosa) , Chukku(Zingiber officinale), Venthayam(Trigonella foenum graecum), Vellai poondu(Allium sativum), Vatathiruppi(Sida acuta), Vasambu(Acorus calamus), Oomam(Carum copticum ). drug is given for 5 days b.d. 10 ml given orally. |