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CTRI Number  CTRI/2024/11/076313 [Registered on: 06/11/2024] Trial Registered Prospectively
Last Modified On: 06/11/2024
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   Comparative Evaluation Of Efficacy Of Adjuvant Role Of Dantimooladi Dhoom In The Managment Of Bronchitis (Kaphaja Kasa) 
Scientific Title of Study   Comparative Evaluation of Efficacy of Adjuvant Role of Dantimooladi Dhoom vs Duolin Nebulization with Standard Care in Children with Bronchitis (Kaphaja Kasa): 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  Mohammad Zafar Mohammad Farooque 
Designation  PG scholar 
Affiliation  Datta Megha Institute of Higher Education Research 
Address  Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  7038433361  
Fax    
Email  drzafar313@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonam Kanzode  
Designation  Associate Professor 
Affiliation  Datta Megha Institute of Higher Education Research  
Address  Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  7387553665  
Fax    
Email  sonamkanzode@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mohammad Zafar Mohammad Farooque 
Designation  PG scholar 
Affiliation  Datta Megha Institute of Higher Education Research  
Address  Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  7038433361  
Fax    
Email  drzafar313@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurveda college And Hospital Research center Salod (Hirapur) Wardha 442001 Maharashtra India 
 
Primary Sponsor  
Name  Mahatma Gandhi Ayurveda Colleege And Hospital And Research Center Salod Hirapur Wardha 
Address  Department of Kaumarbhritya Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha 442001 Maharashtra India 
Type of Sponsor  Research institution and hospital 
 
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 
Mohammad Zafar Mohammad Farooque  Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha   Room no 40 Department of Kaumarbhritya Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha Wardha MAHARASHTRA
Wardha
MAHARASHTRA 		 7038433361

drzafar313@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha 442001 Maharashtra India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J209||Acute bronchitis, unspecified. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-dhUmapAnam, धूमपानम् (Procedure Reference: Vaidya Chintamni vol 1, Procedure details: The Dantimool & Nirgundi Patra are clean and free from any impurities.Dantimool and Nirgundi Patra converted into Churna form. mix the powdered Dantimool and Nirgundi Patra in the equal quantity.Then the acquired Churna are converted into Kalka form for Varti preparation. The Varti along with Ghruta is applied on the tip of Dhoom Varti and administered Dhoom.))
(1) Medicine Name: Dantimooladi dhoom,, Reference: Vaidya Chintamni vol 1, Route: Nasal, Dosage Form: Varti/ Suppository, Dose: 100(mg), Frequency: bd, Duration: 10 Days
2Comparator Arm (Non Ayurveda)-Duolin Respulessalbutamol sulphate and ipratropium bromide. Salbutamol sulphate is a beta2-adrenergic agent which acts on airway muscle resulting in relaxatio Route: Nasal, Dosage Form: Varti/ Suppository, Dose: 100(mg), Frequency: bd, Duration: 10 Days
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Subjects irrespective of sex , religion , socioeconomic status and between the age group of 5–15 years were taken
Subjects and having classical signs and symptom of Kaphaja Kasa
Subjects of Kasa with chronicity of less than 15 days duration (acute cases only )
Bronchitis
 
 
ExclusionCriteria 
Details  Subjects with complication of Kasa i.e. fever, chronic obstructive bronchitis , tuberculosis , lung abscesses , pulmonary edema resulting from cardiac and renal disease , pneumonia .
Subjects with other systematic disorders and metabolic disorders .
Subjects with Kshataj and Kshyaj Kasa , Vataja and Pittaja Kasa 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To asscess the efficacy of Adjuvant Role of Dantimooladi Dhoom Standard Care in Children With Bronchitis (Kaphaja kasa)  0th day 3rd day 5th day 10th day 
 
Secondary Outcome  
Outcome  TimePoints 
To asscess the efficacy of Duolin Nebulization with Standard Care in
Children with Kaphaj kasa Bronchitis 		 0th day 3rd day 5th day 10th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3/ Phase 4 
Date of First Enrollment (India)   30/11/2024 
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)   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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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
    Response (Others) - 
  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drzafar313@gmail.com].

  6. For how long will this data be available start date provided 12-08-2024 and end date provided 12-05-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   N/A Brief Summary The volunteer will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a double blind superiority clinical trial. It will include a 15 days treatment period and assessment during treatment on 1st  3rd 5th 15th day and follow up on 15th day post treatment 
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