FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/03/040712 [Registered on: 02/03/2022] Trial Registered Prospectively
Last Modified On: 11/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “ Role of Markatbija churn on Respiratory Rate in Tamak Shvasa with special reference to Bronchial Asthma” 
Scientific Title of Study   “A Randomised Control Trial on Markatbija churn in Tamak Shvas with special reference to Bronchial Asthma” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandhya Sharma 
Designation  PG 2nd year 
Affiliation  Government ayurved college and hospital Nagpur  
Address  Kayachikitsa department OPD no 1,Government ayurved college and hospital ,Sakkardara square,Nagpur

Nagpur
MAHARASHTRA
440009
India 
Phone  8103969434  
Fax    
Email  sandhyasharma281@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jayant D GUlhane 
Designation  Associate professor  
Affiliation  Government ayurved college and hospital ,Nagpur  
Address  Department of Kayachikitsa OPD 1 , Government ayurved college and hospital Sakkardara square , Nagpur

Nagpur
MAHARASHTRA
440029
India 
Phone  9511828972  
Fax    
Email  Jayant.gulhane.62.6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jayant D GUlhane 
Designation  Associate professor  
Affiliation  Government ayurved college and hospital ,Nagpur  
Address  Department of Kayachikitsa OPD 1 , Government ayurved college and hospital Sakkardara square , Nagpur

Dhule
MAHARASHTRA
440029
India 
Phone  9511828972  
Fax    
Email  Jayant.gulhane.62.6@gmail.com  
 
Source of Monetary or Material Support  
Government ayurved college and hospital ,Sakkardara square,Raghuji nagar,Nagpur  
 
Primary Sponsor  
Name  Government ayurved college and hospital  
Address  Government ayurved college and hospital Sakkardara Nagpur  
Type of Sponsor  Other [Government ayurved college 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 
Sandhya Sharma  Government ayurved college and hospital   Department of Kayachikitsa OPD 1 , Government Ayurved college and hospital,Sakkardara square Nagpur
Nagpur
MAHARASHTRA 		 8103969434

sandhyasharma281@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Government ayurved college Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, (2) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Markatbija Churn  Markatbija churn 5gm bd with 10ml ghrit before meal for 30 days 
Comparator Agent  Tablet Deriphylline Retard   Deriphylline Retard 150mg TDS with water orally for 30 days after meal  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient of Tamak Shvasa presenting the clinical features highlighted in classical literature will be randomly irrespective of sex , caste , religion and socio economical status.
2. Patient of Tamak Shvasa ageing in between 16 to 60 years will be considered.
3. Patient from mild to moderate exacerbation of bronchial asthma.
4. Positive test of reversibility-
a) symptomatic patients- An improvement of 60 L / min or > 20 % in PEFR 10 min after inhalation of bronchodilator ( salbutamol ) .
b) Asymptomatic patient 60 L / min or > 20 % fall in PEFR by provocation with physical exercise ( brisk walking for 5-10 min ) followed by reversal upon in Inhalation of bronchodilator ( salbutamol) when assessed after 10 min .
6. Heemoglobin >10 gm%.
7. Patient willing and able to participate for 4 weeks.
8. Patient showing symptoms, signs and medical history of bronchial asthma will be included. 
 
ExclusionCriteria 
Details  Patient with active lung disease, patient with lung disease other than bronchial asthma, patient who had major surgeries within 2 weeks prior to screening visited , patient with evidence of malignancy, patient with severe asthma exacerbation, pregnant or lactating , patient with poorly controlled hypertension ( >160/100 mmhg) , patient with uncontrolled diabetes mellitus ( blood sugar fasting >130 mg /dl and post meal 250 mg /dl ) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the efficacy of markatbija churn in management of Tamak Shvasa specifically on respiratory rate , peak exploratory flow rate, sustained maximum inspiration and MRC dyspnoea scale.
2. To study the effect of Deriphylline retard in the management of Tamak Shvasa specifically on respiratory rate , peak expiratory flow rate, sustained maximal inspiration and MRC dyspnoea scale.
3. To compare the effect of markatbija churn with tablet Deriphylline retard with respect to respiratory rate , peak expiratory flow rate , sustained maximal inspiration and MRC dyspnoea scale. 		 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study Tamak Shvasa in detail from Ayurvedic perspective.
2. To study bronchial asthma with modern point of view.  		 18 months 
 
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 2/ Phase 3 
Date of First Enrollment (India)   20/03/2022 
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   Nil 
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 - Informed Consent Form

  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 (Others) -  Sandhyasharma281@gmail.com

  6. For how long will this data be available start date provided 20-10-2021 and end date provided 20-10-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   After clearance from Institutional Ethics Committee of Government ayurved college and hospital Nagpur 60 subjects of Tamak Shvasa were recruited from OPD and IPD of Government ayurved college and hospital Nagpur.
During the informed consent process the subjects were given enough time to read the patients information sheet and consent form (ICF), subjects were also given freedom to ask the questions and all the questions were answered. If He/She agrees for the participation in the study and if found fit to include during screening then he was recruited in the study. This visit was called as screening visit.
On the screening visit, after written informed consent, screening of subjects on the Basis of clinical assessment for Peak Expiratory Flow Rate, sustained maximal inspiration, Respiratory Rate and investigations like ECG, CBC ,ESR , chest X-ray along with symptoms of Tamak Shvasa and fulfilling the diagnostic criteria, If all the inclusion criteria is YES and all the exclusion criteria is NO then subjects will be included. If Peak Expiratory Flow Rate is <60L/min and Respiratory rate is > 28/ min .
Subjects were then undergo general and systemic examination clinical symptoms of Tamak Shvasa was assessed and recorded in the Case record form. Study design will be Randomised Control Trial.
In which two different groups of drugs were used. Out of which one is control drug and other is trial drug. For that subjects were assessed clinically and are divided into two groups. 

Control group.                                      Trial group 
1. Tablet Deriphylline Retard 150mg.    Markatbija churn 5gm
2. TDS.                                                  BD
3. with water.                                         With ghrit
4. After meal.                                         Before meal 
Duration of treatment-30 days 

Subjects will be called for follow up visit ( i. e , 0,15 ,30 days respectively) on every follow up visit subjects undergo general and systemic examination, assessment of clinical symptoms, assessment scale, and physical characters was done on every follow up visit.
Patients and investigators global evaluation for overall improvement was done at the end of the study. Tolerability of the trial medicine was assessed by the investigators and patients at the end of the study. All the patients were closely monitored for any adverse events/adverse drug reactions. 
Based on the above study procedures observations were made and recorded in the Case record form for each subject at every follow up. Subjects were assessed for improvement in clinical parameters on Tamak Shvasa.
 
Close