| CTRI Number |
CTRI/2024/08/071907 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to know the effect of siddha medicine Irumal chooranam in the treatment of swasakaasam(Bronchial Asthma) |
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Scientific Title of Study
|
An open clinical trial to evaluate the effectiveness of siddha formulation Irumal chooranam 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 K MADHESHWARAN |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8, Department of Maruthuvam National institute of siddha Tambaram Sanatorium kancheepuram Tamilnadu India
Kancheepuram TAMIL NADU 600047 India |
| Phone |
9566713066 |
| Fax |
|
| Email |
madheshwaran100@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr H NALINI SOFIA |
| Designation |
Associate Professor |
| Affiliation |
National Institute of siddha |
| Address |
Room no 7/8, Department of Maruthuvam National institute of siddha Tambaram Sanatorium kancheepuram Tamilnadu India
Kancheepuram TAMIL NADU 600047 India |
| Phone |
8939899363 |
| Fax |
|
| Email |
dr.h.nalinisofia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr H NALINI SOFIA |
| Designation |
Associate Professor |
| Affiliation |
National Institute of siddha |
| Address |
Room no 7/8, Department of Maruthuvam National institute of siddha Tambaram Sanatorium kancheepuram Tamilnadu India
Kancheepuram TAMIL NADU 600047 India |
| Phone |
8939899363 |
| Fax |
|
| Email |
dr.h.nalinisofia@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha Tambaram Sanatorium Kancheepuram 600047 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheeepuram 600047 |
| 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 K Madheshwaran |
Ayothidoss pandithar hospital |
Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheeepuram 600047 Kancheepuram TAMIL NADU |
9566713066
madheshwaran100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Irumal Chooranam |
A Compound herbal drug powder indicated to treat bronchial asthma advised to intake 1.5 grams twice a day for 48 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who are willing to undergo Pulmonary function test FEV1 between 50%- 80% will be taken.
2.Patients with clinical symptoms of Wheezing, Cough with or without expectoration,Dyspnea, Tightness of chest ,H/O Wheezing minimum 2 episodes per week.Any 2 or more symptoms will be included |
|
| ExclusionCriteria |
| Details |
1.Having covid 19 or recent period of covid 19 infection
2.Restrictive Lung disease
3.Tuberculosis
4.Emphysema
5.Pleural effusion
6.Pneumothorax
7.Cardiac diseases
8.Renal diseases
9.Pregnancy and Lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome is assessed mainly by the values of pulmonary function
test and improvement in the clinical signs and symptoms by asthma control
questionnaire (ACQ) pre and post treatment. |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in laboratory parameters of IgE, Absolute Eosinophil Count(AEC), ESR pre and post 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)
|
15/08/2024 |
| 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 Applicable |
| 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
According to Siddha system of medicine, disease are classified into 4448 types. One among them is Swasakaasam also known as Eraippu noi. Swasakaasam is attributed to the derangement of KaphamThe amplified kapham humour alone or otherwise associated with other deranged humours, either vatham or pitham affect the throat, nose, respiratory air ways and lungs. Due to the increase in kapham humour, mucus secretion is increased causing fever and other symptomps. According to the text Yugi Vaithiya Chinthamani, Kaasam classified into 12 types. “Swasakaasam†is one among them. This can be correlated to “Bronchial asthma†in modern terms. As per the above text, etiology of this disease includes intake of foods which causes rise in kapham humor, allergic foods like ragi, cereals etc, exposure to cold weather and rain, inhalation of smoke, mental stress, anger and unpleasant odour. Asthmatic patients are having a hyper reacting bronchial tree. Bronchoconstriction may be due to various factors, known and unknown. Known substances are Histamine, SRS-A (Slow reacting substance of anaphylaxis), Platelet activating factor(PAF), Eosinophil Chemo tactic factor of Anaphylaxis (ECF-A) and other unidentified substance liberated from the mast cells. The factors responsible for releasing these mediators are allergy, infection, exercise, psychological factors, change of temperature and humidity, smoking etc . In Asthma, Chronic inflammation is associated with airway hyper-responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing particularly at night and in the early morning. These episodes are usually associated with widespread but variable airflow obstruction within the lung that is often reversible, either spontaneously or with treatment. Symptoms may be precipitate by exercise, cold weather, allergens exposure (eg: Pets, Pollen, Dust mites, Occupational, Viral tract Infection), Drugs (B Blockers, Aspirin, NSAIDS), Tobacco smoke, over weight and Emotional Stress . Approximately 300 million people worldwide currently have asthma and its prevalence increases by 50% every decade . It is estimated that there may be an additional 100 million persons with asthma by 2025. Asthma is more common in female adults than male adults. Among them Female adults are 9.8% compared to male adults 6.1%. 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. The total burden of asthma in India an overall prevalence of 3% is estimated at over 30million patients. In India, there is a prevalence of about 2.4% in adults over 15 years of age.
OBJECTIVE
PRIMARY OBJECTIVE â— To evaluate the clinical effectiveness of siddha formulation IRUMAL CHOORANAM in the Management of SWASAKASAM (BRONCHIAL ASTHMA) by using Pulmonary function test.
â— To observe the changes in clinical symptoms by asthma control Questionnaire. SECONDARY OBJECTIVE â— To observe the changes in clinical laboratory parameters such as IGE ,AEC, before and after Treatment.
STUDY DESIGN :An open clinical trial STUDY PLACE :OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai-47.
TREATMENT: Internal medicine: IRUMAL CHOORANAM Dosage : verugadialavu (1.5gm ) twice a day Duration of treatment : 48 days Reference : Brahmamuni karukkadai suthiram 380 Edition : first edition, February 1998 Author : S.B.Ramachandran Published by : Thamarai noolagam, 7,NGO Colony, 3rd street,vadapalani, Chennai.
Sex: Male Female & Transgender.
Patient who are willing to undergo Pulmonary function test (FEV1 between 50% - 80% ) will be taken.
Patients with clinical symptoms of
· Cough with or without expectoration
· H/O Wheezing minimum 2 episodes per week (Any 2 or more symptoms will be included)
Patients who are willing to undergo radiological investigations and provide blood sample for lab investigations.
Having covid 19 (or) recent period of covid 19 infection
WITHDRAWAL CRITERIA: Intolerance to the drug and development of any serious adverse effect during drug trial. Poor patient compliance & defaulters. Patient unwilling to continue the course of clinical Study. Occurrence of any other systemic illness.
PRIMARY OUTCOME Primary Outcome is assessed mainly by the values of pulmonary function test and improvement in the clinical signs and symptoms by asthma control questionnaire(ACQ) pre and post treatment. SECONDARY OUTCOME Changes in laboratory parameters of IgE, Absolute Eosinophil Count(AEC), ESR pre and post treatment. RESULTS AND DISCUSSION The Results will be Statistically analysed and reported. KEYWORDS: Swasakaasam, Irumal chooranam, Respiratory diseases, ACQ.
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