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CTRI Number  CTRI/2024/10/074719 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 28/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Study on the effect of the medicinal recipe called Dasamulakatutraya arka in Tamakasvasa (Bronchial asthma).  
Scientific Title of Study   An uncontrolled clinical trial to assess the effect of Dasamulakatutraya arka in Tamakasvasa with special reference to Bronchial athma. 
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 Syrandri C 
Designation  Postgraduate scholar  
Affiliation  VPSV AYURVEDA COLLEGE KOTTAKKAL 
Address  Department of Dravyagunavijnana Vaidyaratnam P S Varier Ayurveda College Kottakkal Malappuram EDARIKODE PO

Malappuram
KERALA
676501
India 
Phone  6282647764  
Fax    
Email  drsyrandrichandran@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhu K P 
Designation  Associate Professor 
Affiliation  Vaidyaratnam P S Varier Ayurveda College 
Address  Department of Dravyagunavijnana Vaidyaratnam P S Varier Ayurveda College, Edarikkode Post, Malappuram district, Kerala. MALAPPURAM EDARIKODE PO

Malappuram
KERALA
676501
India 
Phone  9745994515  
Fax    
Email  madhusukrutham@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhu K P 
Designation  Associate professor 
Affiliation  Vaidyaratnam P S Varier Ayurveda College 
Address  Department of Dravyagunavijnana, Vaidyaratnam P S Varier Ayurveda College, Edarikkode Post, Kottakkal, Malappuram district, Kerala. KOTTAKKAL MALAPPURAM EDARIKODE PO

Malappuram
KERALA
676501
India 
Phone  9745994515  
Fax    
Email  madhusukrutham@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, Edarikkode Post, Malappuram district, Kerala 676501 
Type of Sponsor  Other [Aided college] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhu KP  Vaidyaratnam P S Varier Ayurveda College, Kottakkal  Department of Dravyagunavijnana Vaidyaratnam P S Varier Ayurveda College, Edarikode Post, Malappuram district,
Malappuram
KERALA 		 9745994515

madhusukrutham@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Vaidyaratnam P S Varier Ayurveda College, Kottakkal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: DASAMULAKATUTRAYA ARKA, Reference: NA, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants who are willing to give Informed consent
Participants having classical signs and symptoms of Bronchial Asthma
Participants satisfying the the mild and moderate diagnostic criteria
Aged between 18 and 65 years irrespective of gender
Participants with forced Expiratory volume in one second which is between 50 percentage and 79 percentage
 
 
ExclusionCriteria 
Details  Status Asthmaticus
Dyspnea due to causes other than Bronchial Asthma
Pregnancy and Lactation
Participants using Inhalers
Participants with diagnosed case of Diabetes mellitus and other chronic diseases
Participants with diagnosed case of Gastritis
Participants under regular medication of Asthma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Subjective parameters for grading Dyspnea Cough Wheezing
Sprirometric evaluation
 		 At baseline and on 30th day
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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 4 
Date of First Enrollment (India)   10/10/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [madhusukrutham@gmail.com].

  6. For how long will this data be available start date provided 10-04-2026 and end date provided 10-04-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   An Uncontrolled clinical trial is planned to assess the effect of Dasamulakatutraya arka in Tamakasvasa with special reference to broncial asthma. The study will be conducted on 30 participants of both genders for a duration of 30 days, wherein 10ml of DasamÅ«lakatutraya Arka will be mixed with 10 ml lukewarm water, half an hour after food, both in the morning and evening. Assessments of the grading of Dyspnea, Wheezing and Cough as well as Spirometric parameters like FEV1 (forced expiratory volume in one second), FVC (Forced vital capacity), FEV1/FVC ratio will be done before and after treatment. The data will be collected and statistically analyzed to draw a conclusion.  
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