| CTRI Number |
CTRI/2018/04/013233 [Registered on: 13/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trail to study the effect of drug LAVANKATHI CHOORANAM on Iya iraippu noi Bronchial Asthma |
|
Scientific Title of Study
|
A prospective open labelled randomized clinical trial on "IYA IRAIPPU NOI" (Bronchial Asthma) with evaluation of trial drug "Lavankathi Chooranam) |
| 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 Sowmiya |
| Designation |
Post Graduate Student |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Scholar Third Year
Department of Pothu Maruthuvan
Government Siddha Medical College and Hospital
Palayamkottai
Government Siddha MEdical College and Hospital
Palayamkottai 627 002
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9894132112 |
| Fax |
|
| Email |
sowmiyascv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR A MANOHARAN MD Siddha |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Government Siddha MEdical College and Hospital
Palayamkottai 627 002
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9443886700 |
| Fax |
04622582010 |
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR A MANOHARAN MD Siddha |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Government Siddha MEdical College and Hospital
Palayamkottai 627 002
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9443886700 |
| Fax |
04622582010 |
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Prof Dr S Neelavathi |
| Address |
Government Siddha Medical College and Hospital
Palayakkottai 627 002
Tirunelveli |
| Type of Sponsor |
Government 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 S SOWMIYA |
Government Siddha Medical College and Hospital |
OPD Room Number - 10, IPD
Department of Pothu Maruthuvam
Government Siddha MEdical College and Hospital
Palayamkottai 627 002
Tirunelveli
TAMIL NADU |
9894132112
sowmiyascv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Siddha Medical College and Hospital Palayamkottai Tirunelveli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
IYA IRAIPPU NOI BRONCHIAL ASTHMA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LAVANKATHI CHOORANAM |
6g two time per day for 20 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Difficulty in Breathing
Tightness of Chest
Wheeze - Add Sound (Rhonchi)
Cough without Expectoration
H/O Allergy, Sneezing
PEFR Male - From 250 l/min to 150 l/min
Female - From 250 l/min to 100 l/min
Spirometer Study |
|
| ExclusionCriteria |
| Details |
Cardiac Diseases
Renal Desease
Tuberculosis
COPD
Status Asthmaticus
Diabetes Mellitus
hypertension
Pragnancy
Lactating Mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Therapeutic efficacy of LAVANKATHI CHOORANAM in the Treatment of IYA IRAIPPU NOI |
20 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Siddha Cofactor Toword the Efficacy of the Traial Drug in the LAVANKATHI CHOORANAM and to Evalute the Pharmacological Action |
40 |
|
|
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)
|
01/07/2017 |
| 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
|
No publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Study is Prospective open labled Randomized Phase - II Clinical Trail to Evaluate the Therapeutic Efficacy of Trail Drug LAVANKATHI CHOORANAM 6g bd for 20 days on the 40 Patients with IYA IRAIPPU NOI that will be conducted in Government Siddha Medical College and Hospital Palayamkottai. The Primary Out come Therapeutic efficacy of LAVANKATHI CHOORANAM The Secondary will be the Evalution of Siddha Diagnostic Parameters. |