| CTRI Number |
CTRI/2023/02/049661 [Registered on: 13/02/2023] Trial Registered Prospectively |
| Last Modified On: |
10/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on Thippili Nei (Medicated ghee) in the management of Swasakaasam (Bronchial Asthma) |
|
Scientific Title of Study
|
A Clinical Evaluation of Siddha Herbal Formulation Thippili Nei in the management of Swasakaasam (Bronchial Asthma) among patients reporting at Out Patient Department of Ayothidoss Pandithar Hospital, National Institute of Siddha. |
| 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 Dharshini |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheepuram Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
6374290636 |
| Fax |
22381314 |
| Email |
dharshiniselvarasu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Vetha merlin kumari |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
22381314 |
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Dharshini |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
6374290636 |
| Fax |
22381314 |
| Email |
dharshiniselvarasu@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room No 7/8 Department of Maruthuvam National Institute of siddha Tambaram Sanatorium Kancheepuram Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dharshini |
National Institute of Siddha |
Room No 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheepuram Chennai 600047
Kancheepuram
TAMIL NADU |
6374290636
22381314
dharshiniselvarasu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayothidoss Pandithar Hospital |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Thippili Nei |
5ml to be given orally twice daily With Hot Water for 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinical symptoms of Wheezing, Cough with or without expectoration, Dyspnea, tightness of chest H/O Wheezing minimum 2 episodes per week
2.Patients who are willing to undergo Pulmonary Function Test (FEV1- 50-80%) will be taken
3.Patients who are willing to undergo radiological investigation and provide blood sample for lab investigation |
|
| ExclusionCriteria |
| Details |
1.Having Covid 19 (or) recent history of covid 19 infection
2. Restrictive Lung diseases
3.Tuberculosis
4.Cardiac diseases
5. Renal diseases
6. Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Outcome is assessed by comparing the lung volumes and capacities in pre and post treatment using Pulmonary function test reports
2. Changes in the clinical symptoms by Asthma Control Questionnaire (ACQ)
3.Changes in the labaratory parameters IgE, AEC, ESR before and after treatment |
2 Month - SCREENING
2 Months - PATIENT ENROLLEMENT
2 Month - OUTCOME ASSESMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3 |
|
Date of First Enrollment (India)
|
15/02/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION: This is an open clinical trial that
evaluates therapeutic effectiveness of siddha formulation THIPPILI NEI in the
management of SWASAKAASAM (BRONCHIAL ASTHMA) patients through improvement in
lung volumes and capacities in pulmonary function test reports, IgE, ESR,
Absolute Eosinophil Count (AEC) before and after treatment and changes in the Asthma
Control Questionnaire(ACQ). Asthma affects 5-10% of the population or an
estimated 23.4 million persons, including 7 million children. Approximately 300
million people worldwide currently have asthma and its prevalence increases
by 50% every decade. Annually, the World Health Organization (WHO) has
estimated that 15 million disability-adjusted life-years are lost and 250,000
asthma deaths are reported worldwide. In Asia, increased prevalence is likely
dramatic in India and china. OBJECTIVE: · To
assess the therapeutic effectiveness of Siddha formulation “THIPPILI NEIâ€
in the management of “SWASAKAASAM†(BRONCHIAL ASTHMA) by
using Pulmonary function test (PFT), IgE, AEC and ESR · To observe the changes in clinical
symptoms by Asthma control Questionaire MATERIALS AND METHODS: A Total of 10 diagnosed patients of Swasakaasam (Bronchial Asthma) within the age
limit of 18 -60 years willing to participate in the study, by signing the
consent form will be enrolled in the study. Having covid -19 (or) recent
history of covid -19 (within 3 weeks), Restrictive Lung diseases, Tuberculosis,
Cardiac diseases and Renal diseases, Pregnancy will be excluded. Assessment is
done through improvement in Asthma Control Questionnaire(ACQ), lung volumes and
capacities in pulmonary function test reports, IgE, ESR, Absolute Eosinophil
Count (AEC) before and after treatment. RESULTS AND DISCUSSION: The result will be statistically
analyzed KEYWORDS: Swasakaasam, Bronchial
Asthma, Thippili nei.
|