| CTRI Number |
CTRI/2023/11/060017 [Registered on: 20/11/2023] Trial Registered Prospectively |
| Last Modified On: |
16/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Evaluation of Siddha Medicine thuthuvelai chooranam for swasakasam (Bronchial asthma)
|
|
Scientific Title of Study
|
Phase II non randomized open clinical evaluation of siddha medicine thuthuvelai chooranam for the
management of swasakasam (Bronchial asthma)
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMAnitha |
| Designation |
PG Scholar |
| Affiliation |
Govt siddha medical college, chennai |
| Address |
Department of PG Pothu Maruthuvam, Govt. Siddha
Medical College, Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
8220674454 |
| Fax |
|
| Email |
Chillani03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnbuN |
| Designation |
HOD and Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department Of Pothu Maruthuvam
Government Siddha Medical College Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMAnitha |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department Of Pothu Maruthuvam
Government Siddha Medical College Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8220674454 |
| Fax |
|
| Email |
chillani03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt siddha medical college, Arumbakkam, chennai-106 |
|
|
Primary Sponsor
|
| Name |
M.Anitha |
| Address |
Department of Post Grauduate Pothu Maruthuvam, Govt. Siddha
Medical College, Arumbakkam, Chennai - 600 106 |
| 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 |
| DrMAnitha |
Government Siddha Medical College, Arumbakkam |
Room No:1, PG Department Of Pothu Maruthuvam,
Chennai
TAMIL NADU |
8220674454
Chillani03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, GSMC, CHENNAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Thuthuvelai chooranam |
650mg, bd after food with honey for 48 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cough with tenacious sputum, Dyspnoea, H/O Wheeze or without wheeze,Chest tightness,Peak expiratory flow rate below 60%
|
|
| ExclusionCriteria |
| Details |
Chronic bronchitis
Bronchiectasis
Bronchogenic carcinoma
Pulmonary TB
Congestive cardiac failure
Bleeding disorders
Pregnancy and lactating mothers
Status asthmaticus
Diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome will be by assessing peak expiratory flow rate above 60% |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in clinical symptoms like wheeze, dyspnoea and chest tightness. |
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)
|
24/11/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Chillani03@gmail.com].
- For how long will this data be available start date provided 01-06-2024 and end date provided 01-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Bronchial asthma is an important public health problem
at the global level. It is a chronic reversible inflammatory destructive
disease of the airways characterized by recurrent
paroxysmal attacks of dyspnea chiefly expiratory in nature accompanied by
wheeze which may subside spontaneously or with treatment. There are
complex and confounding associations and relationships with infections and
infestations, air pollution, tobacco smoking and environmental tobacco smoke
exposure. The overall burden of asthma in India is estimated at more than 15
million patients. Thus, in Siddha system of Medicine, there are unique
combination of medicines, which have solution to the present scenario of Bronchial
asthma. One such combination is THUTHUVELAI CHOORANAM which will be cost
effective and reliable. The method of preparation of the medicine is easy and
the raw drugs are also easily available.
The aim of the study is the management of SWASAKASAM
BRONCHIAL ASTHAMA) with siddha medicine THUTHUVELAI CHOORANAM and the objective
is to determine the therapeutic efficacy and safety profile of the siddha
medicine THUTHUVELAI CHOORANAM in the management of SWASAKASAM BRONCHIAL ASTHAMA).
As the literary evidences support the usage of medicine, in the disease,
hypothesis is created such a way that the efficacy of THUTHUVELAI CHOORANAM will
be a better solution for SWASAKASAM BRONCHIAL ASTHAMA).
|