| CTRI Number |
CTRI/2022/06/043302 [Registered on: 16/06/2022] Trial Registered Prospectively |
| Last Modified On: |
20/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
An open labelled double arm non randomized Phase-II clinical trial to evaluate the efficacy of siddhar yoga maruthuva muraigal and siddha medicine CHITARATHAI PODI(internal medicine)in the management of ALLERGIC ASTHMA |
|
Scientific Title of Study
|
An open labelled double arm non randomized Phase-II clinical trial to evaluate the efficacy of Siddhar yoga maruthuva muraigal and siddha medicine CHITARATHAI PODI(internal medicine)in the management of MANTHARA KAASAM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A VIGNESHWARI |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college and Hospital palayamkottai |
| Address |
II Year PG Scholar Department of Siddhar Yoga Maruthuvam Government Siddha medical college and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9025026657 |
| Fax |
|
| Email |
drvickysiddha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi MDs |
| Designation |
Associate Professor |
| Affiliation |
Government siddha medical college palayamkottai |
| Address |
Department of siddhar yoga maruthuvam
Government Siddha medical college and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mahalakshmi MDs |
| Designation |
Associate Professor |
| Affiliation |
Government siddha medical college palayamkottai |
| Address |
Department of siddhar yoga maruthuvam
Government Siddha medical college and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Dr A VIGNESHWARI |
| Address |
II Year PG Scholar Department of Siddhar Yoga maruthuvam
Government Siddha medical college and Hospital
Palayamkottai
Tirunelveli 627002 |
| Type of Sponsor |
Other [Self] |
|
|
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 A VIGNESHWARI |
Government siddha medical college and Hospital Palayamkottai |
II Year PG scholar Government Siddha Medical college and Hospital Palayamkottai
Tirunelveli
TAMIL NADU |
9025026657
drvickysiddha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CHITARATHAI PODI(internal medicine) |
2 to 4 gm Twice a day for 48 days |
| Comparator Agent |
Siddhar Yoga Therapy along with CHITARATHAI PODI(internal medicine) |
2 to 4 gm twice a day along with Siddhar Yoga Therapy for 48 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20years to 70years
Gender Both Male & Female
Patient have symptoms of Allergic Rhinitis Fever cough with or without expectoration wheezing History of Bronchial Asthma continous sneezing excessive sweating
Patient who are willing to give radilogical investigation and provide blood for lab investigation
Patient who are willing to participate in this studywith the knowledge of potential risk and who are willing to sign the informed consent form |
|
| ExclusionCriteria |
| Details |
Age below 20yrs and above 70years
Patients who face difficulties or hesitate to participate yoga are excluded
History of Fracture within one year
Tumour
Patient who have cardiac illness
Diabetes
Patient have any surgical history within 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the symptoms of Allergic Ashthma |
Reduce the symptoms of Allergic Ashthma |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/06/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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)?
Response - NO
|
|
Brief Summary
|
It is an open labelled double arm non randomized Phase -II clinical trial to evaluate the efficacy of siddhar yoga maruthuva muraigal and Siddha medicine CHITARATHAI PODI(internal medicine )in the management of MANTHARA KAASAM CHITARATHAI PODI DOSAGE: 2 to 4 gm twice a day Along with Siddhar Yoga maruthuva muraiga |