| CTRI Number |
CTRI/2019/07/020223 [Registered on: 17/07/2019] Trial Registered Prospectively |
| Last Modified On: |
16/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
TO EVALUATE EFFICACY OF YOGAM AND NILAVAGAI CHOORANAM FOR BRONCHIAL ASTHMA |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL TRIAL OF YOGAM THERAPY AND NILAVAGAI CHOORANAM (INTERNAL MEDICINE) IN THE MANAGEMENT OF ERAIPPU ERUMAL (BRONCHIAL ASTHMA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Sugasini |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9786534547 |
| Fax |
04422381314 |
| Email |
hasinipalanivel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N J Muthukumar |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444206843 |
| Fax |
|
| Email |
njmuthu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N J Muthukumar |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444206843 |
| Fax |
|
| Email |
njmuthu@hotmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF SIDDHA
|
|
|
Primary Sponsor
|
| Name |
AYOTHIDOSS PANDITHAR HOSPITAL |
| Address |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr P SUGASINI |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| P SUGASINI |
Ayothidoss Pandithar Hospital |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
Kancheepuram
TAMIL NADU |
9786534547
hasinipalanivel@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: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NILAVAGAI CHOORANAM AND YOGAM |
GROUP 1 NILVAGAI CHOORANAM( internal) AND YOGAM
GROUP 2 NILAVAGAI CHOORANAM( internal)
1500mg TWICE A DAY WITH HOT WATER FOR 45DAYS |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 19 to 60 years
Sex Female and Male Transgender
Difficulty in breathing Tightness of chest Wheeze Added sound Rhonchi cough with or without expectoration
History of allergy sneezing
Patient who are willing to take radiological investigation and provide blood for lab investigation
Patients who are willing to estimate volume of air forcibly expired after a deep inspiration by using Pulmonary Function Test
|
|
| ExclusionCriteria |
| Details |
Cardiac disease
Renal disease
Tuberculosis
COPD
Status Asthmaticus
Diabetic mellitus
Hypertension
Pregnancy
Lactation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is mainly assessed by pulmonary function test before and after treatment |
Primary outcome is mainly assessed by pulmonary function test before and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome assessed by comparing the following parameters before and after treatment
Clinical symptoms
Absolute Eosinophils count
ESR
|
1 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/07/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
will be publishing reputed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate therapeutic efficacy yogam and Nilavagai chooranam in the management of bronchial asthma. |