| CTRI Number |
CTRI/2019/06/019754 [Registered on: 19/06/2019] Trial Registered Prospectively |
| Last Modified On: |
20/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [SIDDHAR YOGAM THERAPY] |
| Study Design |
Other |
|
Public Title of Study
|
Clinical trial on trial on eraippu erumal with yoga therapy |
|
Scientific Title of Study
|
An open labelled non randomised phase II comparitive clinical trial to evaluate the therapeutic efficacy of SIDDHAR YOGAM THERAPY and KHARUN THULASI KARPAM (SIDDHA KALPA MEDICINE INTERNAL) for 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 |
S MUTHU VIGNESH |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College Hospital |
| Address |
21C ANNAI INDIRA NAGAR
NEAR ANNA STADIUM
PALAYAMKOTTAI
PG scholar
Dept of siddhar yoga maruthuvam
Govt siddha medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9566757400 |
| Fax |
|
| Email |
am030294@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A S POONGODIKANTHMATHI |
| Designation |
PROFESSOR |
| Affiliation |
Govt Siddha Medical College Hospital |
| Address |
DEPT OF SIRAPPU MARUTHUVAM
GOVT SIDDHA MEDICAL COLLEGE
PALAYAMKOTTAI
TIRUNELVELI
Dept of siddhar yoga maruthuvam Sirappu maruthuvam
Govt siddha medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S MUTHU VIGNESH |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College Hospital |
| Address |
21C ANNAI INDIRA NAGAR
NEAR ANNA STADIUM
PALAYAMKOTTAI
PG scholar
Dept of siddhar yoga maruthuvam
Govt siddha medical college and hospital
Palayamkottai
TAMIL NADU
627002
India |
| Phone |
9566757400 |
| Fax |
|
| Email |
am030294@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
S MUTHU VIGNESH |
| Address |
21C ANNAI INDIRA NAGAR
NEAR ANNA STADIUM
PALAYAMKOTTAI |
| Type of Sponsor |
Other [Govt Siddha 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 |
| S MUTHU VIGNESH |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI TIRUNELVELI |
Room no 4
Department of siddhar yoga maruthuvam
Govt siddha medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU |
9566757400
am030294@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Govt Siddha Medical College Palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J709||Respiratory conditions due to unspecified external agent, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
SIDDHAR YOGAM THERAPY WITH SIDDHA KALPA MEDICINE KHARUN THULASI KARPAM |
SIDDAR YOGAM THERAPY for 48 days
With
KHARUN THULASI KARPAM
DOSE 1-2Gms od
DURATION-48 Days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with the symptoms of
Nasal congestion
Rhinorrhea
Tightness of chest
Recurrent attacks of dyspnoea
Cough with expectoration
Wheezing added sound (Rhonchi)
H/O allergy, sneezing.
Patients who are willing to take radiological investigation and provide blood for lab investigation.
|
|
| ExclusionCriteria |
| Details |
Patient with
Age group less than 15 and above 65 years
Systemic Hypertension
Cardiac disease
Renal disease
Tuberculosis
Chronic Bronchitis
Status Asthmaticus
Auto immune disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Before and after treatment measurements of HR/PR/RR/BP will give the efficacy data
Hopefully helps to know about the comparative therapeutic efficacy data |
Group I - Intermittent siddhar yogam therapy within 48 days
Ist sitting 50 percentage of symptoms will reduce
IInd sittind 80 percentage of symptoms will reduce
Group II after giving internal medicine for 48 days 40 percentage of symptoms will reduce
After giving both internal and external yoga therapy for 48 days 80 percentage of symptoms will reduce |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Before and after treatment measurements of HR/PR/RR/BP will give the efficacy data
Hopefully helps to know about the comparative therapeutic efficacy data |
Group I - Intermittent siddhar yogam therapy within 48 days
Ist sitting 50 percentage of symptoms will reduce
IInd sittind 80 percentage of symptoms will reduce
Group II after giving internal medicine for 48 days 40 percentage of symptoms will reduce
After giving both internal and external yoga therapy for 48 days 80 percentage of symptoms will reduce |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/06/2019 |
| Date of Study Completion (India) |
24/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Bronchial asthma is a very
common disease in the society due to increasing exposure to air pollution and
western life style.It is common in both sex but more prevalent among males,
while during adolescence and adulthood,it affects girls and women more.
Bronchial Asthma (from the Greek-Panting) is a chronic
inflammatory disease which produces bronchial hypersensitivity characterised by
reversible airway obstruction, mucosal oedema, constriction of the bronchial
musculature and excessive secretion of viscid mucus,causing mucous plugs.
|