| CTRI Number |
CTRI/2017/05/008540 [Registered on: 12/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
09/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Research of Siddha Medicine in the treatment of Sooli Kanam (Childhood Asthma) |
|
Scientific Title of Study
|
A Clinical Evaluation of Thulasi Ennai a Siddha Drug in the treatment of Soolikanam (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 |
Dr S Yavanarani |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhandai Maruthuvam
National Institute of Siddha Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
944891147 |
| Fax |
04422381314 |
| Email |
dr.yavana25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Meenakshisundaram |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhandai Maruthuvam
National Institute of Siddha Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
04422381314 |
| Email |
mmssiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Meenakshisundaram |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhandai Maruthuvam
National Institute of Siddha Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
04422381314 |
| Email |
mmssiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital
National Institute of Siddha Tambaram sanatorium
Chennai 600047
Kancheepuram District
Tamilnadu |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram sanatorium
Chennai 600047
Kancheepuram District
Tamilnadu |
| 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 |
| Dr S Yavanarani |
National Institute of Siddha |
OPD number 4
Department of Kuzhandai Maruthuvam
National Institute of Siddha Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU |
944891147
04422381314
dr.yavana25@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 |
Soolikanam (Childhood Asthma)
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Thulasi Ennai (Internal) |
5ml of Thulasi Ennai
administered orally OD dose at morning for a period of 40 days. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Age : 7 – 12 years
2. Cough
3. Wheezing
4. Tightness of chest
5. Shortness of breath
6. Abdominal bloating
7. Loss of appetite
|
|
| ExclusionCriteria |
| Details |
1. Children below 7 years and above 12 years
2. Haemoptysis
3. Pneumonia
4. Congenital heart disease
5. Status Asthmaticus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of the trail drug is measured by Peak Expiratory Flow Meter |
Before treatment (0th day) and After treatment (40th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome is assessed by comparing the following parameters before and after the treatment
1.Improve clinical symptoms
2.Reduction in AEC and ESR |
Before treatment and After treatment |
|
|
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 3 |
|
Date of First Enrollment (India)
|
21/01/2017 |
| 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
|
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, non-randomized, open-label trial to determine the efficacy and
safety of THULASI ENNAI (Prepared from herbal constitutents) in patients
with SOOLI KANAM (CHILDHOOD ASTHMA). In this trial 40 patients will
be recruited and the trial drug will be administered orally twice a day
for a period of 40 days. During this trial period all the study related
data will be recorded and documented in a page separate trial master file
for each patients.During the trial period if any AE/SAE/SUSAR will be noticed
and referred to pharmacovigilance dept in NIS and further management will
also be given in NIS OPD/IPD.The entire trial will be monitored by the
research monitoring committee of NIS. During this trial all
the safety and efficacy parameters will be recorded in the CRF. After
completion of the trial all the study related data will be analysed
statistically. The outcome of this trial will be published in
Indian Journal of Medical Research. |