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CTRI Number  CTRI/2024/10/075854 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 07/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "A Study Comparing the Effectiveness of Dugdhika (a natural plant remedy) vs. Salbutamol (an asthma medication) in Treating Bronchial Asthma (tamaka shwasa): A Randomized Trial" 
Scientific Title of Study   Evaluation of comparative efficacy of inhalation of Dugdhika (Euphorbia prostrata w. Ait) versus Salbutamol in the management of Tamaka Shwasa(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  Dr Bhavesh Manohar Dangore  
Designation  PG Scholar 
Affiliation  Mahatma Gandhi Ayurved College Hospital And Research Centre  
Address  Room no 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod hirapur Wardha Maharashtra
Salod hirapur wardha
Wardha
MAHARASHTRA
442001
India 
Phone  9922412421  
Fax    
Email  bhaveshdangore@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sadhana Misar Wajpeyi 
Designation  Professor  
Affiliation  Mahatma Gandhi Ayurved College Hospital And Research Centre  
Address  Room no 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod hirapur Wardha Maharashtra
Salod hirapur wardha
Wardha
MAHARASHTRA
442001
India 
Phone  9763732083  
Fax    
Email  sadhanamisar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhavesh Manohar Dangore  
Designation  PG Scholar  
Affiliation  Mahatma Gandhi Ayurved College Hospital And Research Centre  
Address  Room no 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod hirapur Wardha Maharashtra
Salod hirapur wardha
Wardha
MAHARASHTRA
442001
India 
Phone  9922412421  
Fax    
Email  bhaveshdangore@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurved College Hospital And Research Centre room no 30 department of kayachikitsa dist wardha 442001 state maharashtra country india  
 
Primary Sponsor  
Name  Dr Bhavesh Manohar Dangore  
Address  Room No 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod hirapur wardha  
Type of Sponsor  Other [self ] 
 
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 Bhavesh Manohar Dangore  Mahatma Gandhi Ayurved College Hospital And Research Centre salod hirapur wardha  room no 30 department of kayachikitsa mahatma gandhi ayurved college hospital and research centre salod hirapur wardha 442001
Wardha
MAHARASHTRA 		 9922412421

bhaveshdangore@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MGACH&RC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: TAMAKASVASAH, (2) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dugdhika (Euphorbia prostrata w. Ait), Reference: priyavat nighantu, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2.5(ml), Frequency: sos, Bhaishajya Kal: Samudga, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Salbutamol Salbutamol, also known as albuterol, it works as Bronchodilator and Short-acting β2-adrenergic receptor agonist (SABA) to relieve symptoms of bronchial asthma, chronic obstructive pulmonary disease (COPD), and other conditions that cause reversible airway obstruction. This drug is given by nasal route with dose of 2.5 ml SOS
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  A patient who is willing to take part and provides signed, informed permission
Patients having cardinal signs and symptoms of Tamaka Shwasa which are mild and
moderate severity. 
 
ExclusionCriteria 
Details  patients suffering from systemic diseases like diabetes, heart disease, renal disease, COPD,
cancer, tuberculosis, status asthmaticus and other major health problems, lactating and
pregnant women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1 To assess the efficacy of Dugdhika inhalation on spirometry and PEFR in Tamaka
Shwasa bronchial asthma
2 To assess the efficacy of Salbutamol inhalation on spirometry and PEFR in Tamaka
Shwasa bronchial asthma
3 To compare the efficacy of Dugdhika and Salbutamol inhalation on spirometry and
PEFR in Tamaka Shwasa bronchial asthma 		 1 day  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in spirometry & PEFR values  1 day 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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   N/A 
Date of First Enrollment (India)   27/12/2024 
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="1"
Days="2" 
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   The volunteers will be informed about the study protocol. willing participants will be randomly selected as per computerized method . clinical research format will be prepared and validated. prior to the study approval will be taken from IEC, MGACHRC Salod hirapur wardha and CTRI registeration wil  be done. After selection, participants will be tested individually and selected according to selection criteria. they have divided into two groups the trial is a parallel group, randomized single blind standard controlled trial. It will be given for one time. 
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