| CTRI Number |
CTRI/2024/03/064944 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Evaluate the Efficacy of Siddha Medicines in Bronchial Asthma |
|
Scientific Title of Study
|
A Single-Centric, Single-Arm Pilot Study to Evaluate the Safety and Efficacy of Swasa Kudori Chooranam (SKC) In the Management of Swasa Kaasam (Bronchial Asthma) |
| Trial Acronym |
SKC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Shunmugaram |
| Designation |
Research Officer (Siddha) |
| Affiliation |
Siddha Regional Research Institute |
| Address |
Room No.6,
First Floor,
Siddha Regional Research Institute,
Chellaperumal Street, Kuyavarpalayam,
Puducherry.
Pondicherry
PONDICHERRY
605013
India |
| Phone |
8608533131 |
| Fax |
|
| Email |
dr.s.s.ram28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Shunmugaram |
| Designation |
Research Officer (Siddha) |
| Affiliation |
Siddha Regional Research Institute |
| Address |
Room No.6,
First Floor,
Siddha Regional Research Institute,
Chellaperumal Street, Kuyavarpalayam,
Puducherry.
Pondicherry
PONDICHERRY
605013
India |
| Phone |
8608533131 |
| Fax |
|
| Email |
dr.s.s.ram28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Lavanya |
| Designation |
Research Officer (Siddha) |
| Affiliation |
Siddha Regional Research Institute |
| Address |
Room No.2, First Floor,
Siddha Regional Research Institute,
Chellaperumal Street, Kuyavarpalayam, Puducherry.
Pondicherry
PONDICHERRY
605013
India |
| Phone |
9042606902 |
| Fax |
|
| Email |
drlavi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Siddha, Ministry of Ayush, Govt. of India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Siddha, Ministry of Ayush, Govt. of India |
| Address |
Tambaram sanatorium, GST Road,
Chennai – 600 047, 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 S Shunmugaram |
Siddha Regional Research Institute |
OPD No. 1,
Clinical Department,
Siddha Regional Research Institute,
Chellaperumal Street,
Kuyavarpalayam,
Puducheery.
Pondicherry
PONDICHERRY |
8608533131
dr.s.s.ram28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Siddha Regional Research Institute - Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J452||Mild intermittent asthma, (2) ICD-10 Condition: J453||Mild persistent asthma, (3) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Swasa Kudori Chooranam |
1 gram of chooranam with honey, TDS, after food, orally for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Symptoms of dry cough, recurrent attacks of dyspnoea, hoarseness of voice, tightness of chest, profuse sweating, and wheezing
2. Asthmatic attack due to seasonal changes and allergens
3. Willing to take radiological investigation and provide blood samples for lab investigation.
4. FEV1 with 50-80% |
|
| ExclusionCriteria |
| Details |
1. Asthma associated with COPD
2. Unstable bronchial asthma or status asthmaticus.
3. Asthma exacerbation during the past month.
4. COVID 19 Positive patients (on the time of recruitment).
5. Tuberculosis, Pneumonia, and Bronchogenic carcinoma
6. Cardiac, Liver and Renal Diseases.
7. Participation in another clinical trial within the preceding 90 days of the study starts.
8. Pregnant and lactating women.
9. Subjects with a continuing history of Alcohol, Smoking or Drug Abuse. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Effect of the trial drug will be assessed by Mean Improvement in Pulmonary Function Test, Asthma Control Test and MMRC Dyspnoea Scale from baseline.
2. Effect of the trial drug will be assessed by Mean Improvement in Quality of Life of trial participants assessed by Asthma Quality of Life Questionnaire with Standardized Activities from baseline. |
PFT, Asthma Control Test, MMRC Dyspnoea Scale and Asthma Quality of Life Questionnaire will be done on Day 0,16,31 and 121 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Safety of the study drug will be assessed by using following parameters: LFT, RFT, CRP and Urine routine on 0 day, 31st day and 121st day.
2. Effect of the trial drug will be assessed by Mean improvement in reducing the frequency of using allopathic drugs for acute asthmatic attacks. |
Will be done on Day 0, 31 and 121 |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
06/05/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
In Siddha Medicine, the diseases that occurred in the respiratory system were classified as Kaasam, Irumal, Iraippu and Ilaippu etc. Swasa Kaasam is described as one of the twelve types of Kaasam characterized by paroxysmal dyspnoea, chest discomfort, emaciation and respiration associated with musical sounds can be correlated with the Bronchial Asthma in modern medicine. This study aims to determine the effect of Siddha formulation Swasa Kudori Chooranam (SKC) in Mild and Moderate Asthmatic populations. Swasa Kudori Chooranam (SKC) is a classical Siddha formulation that is prescribed for 96 types of respiratory disorders, including cold, cough and tuberculosis. The ingredients of SKC possess antiviral, anti-inflammatory, bronchodilator, and anti-nociceptive activities. The preclinical study in SKC also revealed that this drug have a significant Bronchodilation activity. The effect will be evaluated by the mean change in FEV1, FVC, Asthma Control Test, Modified Medical Research Council Dyspnea Scale and Asthma Quality of Life Questionnaire. Thus, the results of this trial will validate the safety and efficacy of Swasa Kudori Chooranam (SKC) on Swasa Kaasam (Bronchial Asthma) patients. |