| CTRI Number |
CTRI/2024/05/067248 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the Efficacy of Mudgadi yusha in Bronchial Asthma |
|
Scientific Title of Study
|
Efficacy of Mudgadi yusha as add on therapy in mild to moderate persistent Bronchial Asthma-A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AnjuNiveditha MK |
| Designation |
PG Scholar |
| Affiliation |
vaidyaratnam p. s varier Ayurveda College Kottakkal |
| Address |
Swasthavritta Department
Room no 201
Vaidyaratnam p.s varier Ayurveda college
kottakkal
Edarikode P O
Malappuram
Kerala
Malappuram
KERALA
676501
India |
| Phone |
8281488680 |
| Fax |
|
| Email |
anjuniveditha@gmail.come |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M C Shobhana |
| Designation |
Professor and HOD |
| Affiliation |
Vaidyaratnam p. s varier Ayurveda College Kottakkal |
| Address |
Department of swasthavritta
Vaidyaratnam p. s varier Ayurveda college kottakkal
Malappuram
Kerala
Malappuram
KERALA
676501
India |
| Phone |
9446321535 |
| Fax |
|
| Email |
drshobhamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M C Shobhana |
| Designation |
Professor and HOD |
| Affiliation |
Vaidyaratnam p. s varier Ayurveda College Kottakkal |
| Address |
Department of swasthavritta
Vaidyaratnam p. s varier Ayurveda college kottakkal
Malappuram
Kerala
Malappuram
KERALA
676501
India |
| Phone |
9446321535 |
| Fax |
|
| Email |
drshobhamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam p. s varier Ayurveda college Kottakkal
|
|
|
Primary Sponsor
|
| Name |
Vaidyaratnam p s varier Ayurveda College Kottakkal |
| Address |
Vaidyaratnam p.s varier Ayurveda College Kottakkal
Edarikode P O
Kottakkal
Malappuram
Kerala
676501 |
| Type of Sponsor |
Other [Aided College] |
|
|
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 |
| AnjuNiveditha MK |
Vaidyaratnam p. s varier Ayurveda College Hospital kottakkal |
Swasthavritta department
Room number 201
Edarikode post
676501
Malappuram
KERALA |
8281488680
anjuniveditha@gmail.come |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee(IEC) Vaidyaratnam p. s varier Ayurveda College Kottakkal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mudgadi yusham, Reference: Charaka samhitha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 120(ml), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Balajirakadi kashayam, Reference: sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 60(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Agasthya rasayana, Reference: Aashtanga Hrudayam, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Those satisfying diagnostic criteria for mild to moderate persistent Bronchial Asthma
Chronicity up to 5 years
Age 20-60 years of all gender
Those willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
Diagnosed cases of other respiratory pathologies (COPD) Bronchitis, Bronchiectasis,Tuberculosis,Malignancies
Those on other medications for Asthma
Known cases of systemic illness
Pregnant and lactating women
Those unfit for administration of kshara |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of subjective parameters using Asthma control questionnaire(ACQ)
Asthma quality of life questionnaire (AQLQ)
Grading for Cough, Wheezing Dyspnea |
0th day 16th day 31st day and as a follow-up up on 46th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective assessment using Spirometry-FEV1, FVC
CBC
ESR
Absolute Eosinophilic count |
0th day 31st day |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="6"
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
|
For this study 42 participants will be selected according to inclusion criteria. They will be randomly allocated to two groups namely trial group and control group with 21 participants each. The trial group participants will receive Mudgadi yusha 120 ml at 7am and 7 pm ,Balajirakadi kashaya (15ml kashaya +45 ml water at 6 am 6 pm and Agasthya rasayana 10 gm at 9 pm) daily for 30 days. The control group will receive Balajirakadi kashaya (15ml kashaya +45 ml water at 6 am 6 pm and Agasthya rasayana 10 gm at 9 pm) daily for 30 days.Assessment would be done on 0th day, 16th day, 31st day and follow up on 46th day using Asthma Control Questionnaire, Grading method of Dyspnoea, Wheezing and cough,Asthma Quality of life Questionnaire. |