| CTRI Number |
CTRI/2025/04/084371 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Trial to evaluate the effectiveness of siddha formulation Thirikadugu Dravagam in the management of Swasakaasam |
|
Scientific Title of Study
|
An Open Clinical trial to Clinical Trial to evaluate the effectiveness of siddha formulation Thirikadugu Dravagam in the management of Swasakaasam (Bronchial Asthma) among patients reporting at Ayothidoss Pandithar Hospital,National Institute of Siddha.
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavyasri V |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai 600047
Tamilnadu
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
08072535167 |
| Fax |
|
| Email |
kavyasiddhadoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T LAKSHMIKANTHAM |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai 600047
Tamilnadu
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9025575185 |
| Fax |
|
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T LAKSHMIKANTHAM |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai 600047
Tamilnadu
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9025575185 |
| Fax |
|
| Email |
drlakshmiramaswamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,
Tambaram Sanatorium,
Chennai 600047 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room no 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai 600047
Tamilnadu
India |
| 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 KAVYASRI V |
National institute of Siddha |
Department of Maruthuvam,
Ayothidoss Pandithar Hospital,
National Institute of Siddha,Tambaram Sanatorium,
Chennai 600047
Kancheepuram
TAMIL NADU |
8072535167
kavyasiddhadoc@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 |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Thirikadugu Dravagam |
5 ml bds with luke warm water ,oral route for 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are willing to undergo a Pulmonary function test (FEV1 between 50% - 80%) will be included.
2.Patients with any 2 or more of the following clinical symptoms will be included:
H/O Wheezing minimum 2 episodes per week
Cough with or without expectoration
Dyspnea
Tightness of chest
3.Patients who are willing to undergo radiological investigations and provide blood samples for lab investigations.
|
|
| ExclusionCriteria |
| Details |
K/H/O Restrictive Lung diseases
K/H/O Tuberculosis
K/H/O Emphysema
K/H/O Pleural effusion
K/H/O Pneumothorax
K/H/O Cardiac diseases
K/H/O Renal diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome is assessed by comparing the improvement in the clinical signs and symptoms by Asthma Control Test (ACT) before and after treatment. |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in laboratory parameters of CBC, IgE, and Absolute Eosinophil Count (AEC) before and after treatment and improved lung volumes and capacities using Pulmonary Function Tests before and after treatment. |
48 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/04/2025 |
| 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 - NO
|
|
Brief Summary
|
BACKGROUND:
Siddha
system of medicine is one of the traditional systems of medicine, originated from
the South. According to the Siddha system, five elements exist in nature:earth,
water, fire, air, and ether, all of which form the basis of all corporeal
things. According to the theories of humoral pathology, all diseases are caused
by the discordant mixture of vatham, pitham, and kabham. In the Siddha system
of medicine, Swasakaasam is correlated with bronchial asthma. Bronchial asthma
is a common respiratory disorder. 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.
PRIMARY
OBJECTIVE:
To
evaluate the clinical effectiveness of Siddha formulation THIRIKADUGU
DRAVAGAM in the Management of SWASAKAASAM (BRONCHIAL ASTHMA) through
the changes in clinical symptoms by using the Asthma Control Act (ACT) before
and after treatment.
SECONDARY
OBJECTIVE:
1.To
observe the changes in clinical laboratory blood parameters such as IGE, AEC
and ESR before and after treatment.
2.To study
the changes in FEV1 values using the Pulmonary Function Test before and after treatment.
TREATMENT:
Internal
medicine : THIRIKADUGU
DRAVAGAM
Dosage : (5 ML) twice a day
Adjuvant
: Luke warm water
Duration
of treatment : 48
days
PRIMARY
OUTCOME:
Primary
Outcome is assessed by comparing the improvement in the clinical signs and
symptoms by Asthma Control Test (ACT) before and after treatment.
SECONDARY
OUTCOME:
Changes in
laboratory parameters of CBC, IgE, and Absolute Eosinophil Count (AEC) before
and after treatment and improved lung volumes and capacities using Pulmonary Function
Tests before and after treatment.
|