| CTRI Number |
CTRI/2015/01/005466 [Registered on: 27/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
26/01/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL RESEARCH ON “SWASAKASAM†(BRONCHIAL ASTHMA) WITH SIDDHA DRUG “THALAGA KULIGAI†|
|
Scientific Title of Study
|
A PRECLINICAL AND CLINICAL STUDY ON“THALAGA KULIGAI†FOR THE TREATMENT OF SWASAKASAM(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 R CHITHRADEVI |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF POTHU MARUTHUVAM
GOVERNMENT SIDDHA MEDICAL COLLEGE
ARUMBAKKAM
CHENNAI 106
DEPARTMENT OF POTHU MARUTHUVAM
GOVERNMENT SIDDHA MEDICAL COLLEGE
ARUMBAKKAM
CHENNAI 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9629212347 |
| Fax |
|
| Email |
chithu.devir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR P PARTHIBHAN |
| Designation |
HOD POTHU MARUTHUVAM PG |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF POTHU MARUTHUVAM
GOVERNMENT SIDDHA MEDICAL COLLEGE
ARUMBAKKAM
CHENNAI 106
DEPARTMENT OF POTHU MARUTHUVAM
GOVERNMENT SIDDHA MEDICAL COLLEGE
ARUMBAKKAM
CHENNAI 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444284684 |
| Fax |
|
| Email |
parniru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR K KANAKAVALLI |
| Designation |
HOD POTHU MARUTHUVAM UG |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF POTHU MARUTHUVAM
GOVERNMENT SIDDHA MEDICAL COLLEGE
ARUMBAKKAM
CHENNAI 106
DEPARTMENT OF POTHU MARUTHUVAM
GOVERNMENT SIDDHA MEDICAL COLLEGE
ARUMBAKKAM
CHENNAI 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444122865 |
| Fax |
|
| Email |
drkkanakavalli@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT SIDDHA MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SIDDHA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF POTHU MARUTHUVAM
GOVERNMENT SIDDHA MEDICAL COLLEGE
ARUMBAKKAM
CHENNAI 106 |
| 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 R CHITHRA DEVI |
GOVERNMENT ARIGNAR ANNA HOSPITAL |
PG POTHU MARUTHUVAM
ROOM NUMBER 4C
GOVT SIDDHA MEDICAL COLLEGE
ATTACHED WITH
GOVT ARIGNAR ANNA HOSPITAL ARUMBAKKAM CHENNAI
Chennai
TAMIL NADU |
9629212347
chithu.devir@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 |
MALE AND FEMALE WITH COUGH WITH OR WITHOUT EXPECTORATION DYSPNOEA AND WHEEZE, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
THALAGA KULIGAI |
DOSAGE 1 TABLET 100MG TDS
ADJUVANT HONEY
DURATION 48 DAYS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical signs and symptoms of bronchial asthma
Dyspnoea Wheeze
Cough with or without expectoration
Willing to give specimen of blood for investigation.
Willing to attend the OPD once in 7 days
|
|
| ExclusionCriteria |
| Details |
Congestive cardiac failure.
Bronchiectasis.
Bronchogenic carcinoma
Pulmonary TB
Chronic bronchitis
Pregnancy
Chronic bronchitis.
Pregnancy
|
|
|
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 reduction in clinical symptoms and by comparing the peak expiratory flow rate before and after treatment |
48 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the safety parameters before and after treatment |
48 DAYS |
|
|
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)
|
22/03/2014 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS IS AN OPEN CLINICAL STUDY ON SWASAKASAM(BRONCHIAL ASTHMA) WITH THE EVALUATION OF TRIAL DRUG THALAGA KULIGAI.40 PATIENTS INCLUDED IN THE TRIAL AND TRIAL DRUG IS GIVEN AND MONITORED.THE COMPOSITION OF TRIAL DRUG IS AS FOLLOWS ARSENIC TRISULPHIDEMERCURY sODIUM BICARBONATE DRIED ZINGER Piper longum Eclipta prostrata leaf juice |