| CTRI Number |
CTRI/2025/04/086062 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SADAMANJIL CHOORANAM AND SADAMANJIL CHOORANAM WITH SIDDHAR YOGA MARUTHUVA MURAIGAL IN THE MANAGEMENT OF ERAIPPU
(BRONCHIAL ASTHMA)
|
|
Scientific Title of Study
|
AN OPEN LABELLED DOUBLE ARM NON RANDOMIZED PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SADAMANJIL CHOORANAM AND SADAMANJIL CHOORANAM WITH SIDDHAR YOGA MARUTHUVA MURAIGAL IN THE MANAGEMENT OF ERAIPPU
(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 |
DR S SATHISH KUMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
SECOND YEAR, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8778769094 |
| Fax |
|
| Email |
sathishkumar17121998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR V MAHALAKSHMI MD SIDDHA |
| Designation |
PROFESSOR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
HEAD OF THE DEPARTMENT, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR V MAHALAKSHMI MD SIDDHA |
| Designation |
PROFESSOR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
HEAD OF THE DEPARTMENT, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD FACILITIES AND CENTRAL LIBRARY OF GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAIYAMKOTTAI, TIRUNELVELI, TAMIL NADU, INDIA PIN 627002. |
|
|
Primary Sponsor
|
| Name |
DR S SATHISH KUMAR |
| Address |
SECOND YEAR, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI, TIRUNELVELI, TAMIL NADU, INDIA PIN 627002. |
| 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 |
| DR S SATHISH KUMAR |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
SECOND YEAR, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU |
8778769094
sathishkumar17121998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTERNAL MEDICATION |
SADAMANJIL CHOORANAM 1-3 GRAMS TWICE DAILY WITH ADJUVANT LUKE WARM WATER AS INTERNAL MEDICINE FOR A PERIOD OF 48 DAYS |
| Comparator Agent |
INTERNAL MEDICATION AND SIDDHAR YOGA MURAIGAL |
SADAMANJIL CHOORANAM 1-3 GRAMS TWICE DAILY WITH ADJUVANT LUKE WARM WATER AS INTERNAL MEDICINE AND PRANAYAMAM, TIRIKONASANAM, BHUJANGASANAM, ARDHA MACHASANAM, SAVASANAM AS SIDDHAR YOGA MURAIGAL FOR A PERIOD OF 48 DAYS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Breathlessness, Wheezing with unproductive cough, Chillness of limbs, Obstructive Sleep Apnea, Allergic Rhinitis, Sputum expelled with cough with dyspnea |
|
| ExclusionCriteria |
| Details |
Chronic Bronchitis, Pulmonary Tuberculosis, Sinusitis, Interstitial Lung disease, Bronchiectasis, Any other serious systemic illness, Pregnancy and Lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study aims at bringing light on the Efficacy of the long standing traditional practice of Siddha Yogam Muraigal and Sadamanjil chooranam towards the management of Eraippu (Bronchial Asthma ). |
48 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The positive impact of Yoga in the management aspect may be highlighted through this study. |
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)
|
14/05/2025 |
| 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="2"
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
|
It is an open labelled double arm non randomized phase II Clinical trial to evaluate the efficacy of,
A. INTERNAL MEDICATION 1. SADAMANJIL CHOORANAM
Dosage: 1to 3 grams twice a day with Luke warm water after food administered to Group A containing 20 participants for a period of 48 Days
B. INTERNAL MEDICATION AND SIDDHAR YOGIC INTERVENTIONS
Synergistic effect of the INTERNAL MEDICATION Sadamanjil Chooranam along with SIDDHAR YOGIC INTERVENTIONS including Pranayamam, Tirikonasanam, Bhujangasanam, Ardha Machasanam and Savasanam to Group B containing 20 participants for a period of 48 days
The efficacy of treatment is monitored and assessed through peak flow meter. |