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CTRI Number  CTRI/2019/04/018376 [Registered on: 02/04/2019] Trial Registered Prospectively
Last Modified On: 27/03/2019
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   Ayurveda management of Bronchial Asthma. 
Scientific Title of Study   A Clinical Randomised Control Study On Efficacy Of “Kiratadi Kwath” In Tamak Shvasa 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  Prasanna Deshpande 
Designation  MD Kaychikitsa(PG Scholar) 
Affiliation  Government Ayurved College,Nagpur.  
Address  Department Of Kaychikitsa Govt. Ayurved College,Sakkardara Chowk , Nagpur.

Nagpur
MAHARASHTRA
440009
India 
Phone  8983740167  
Fax  07122749198  
Email  prasannadeshpande486@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jayant Gulhane 
Designation  Associate professor 
Affiliation  Government Ayurved College,Nagpur.  
Address  Department Of Kaychikitsa Govt. Ayurved College,Sakkardara Chowk , Nagpur.

Nagpur
MAHARASHTRA
440009
India 
Phone  9511828972  
Fax  07122749198  
Email  jayant.gulhane.62.6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jayant Gulhane 
Designation  Associate professor 
Affiliation  Government Ayurved College,Nagpur.  
Address  Department Of Kaychikitsa Govt. Ayurved College,Sakkardara Chowk , Nagpur.

Nagpur
MAHARASHTRA
440009
India 
Phone  9511828972  
Fax  07122749198  
Email  jayant.gulhane.62.6@gmail.com  
 
Source of Monetary or Material Support  
Self(Prasnna Deshpande)Department Of Kaychikitsa Government Ayurved College,Nagpur. 
 
Primary Sponsor  
Name  Government Ayurved CollegeNagpur 
Address  Department Of Kaychikitsa Govt. Ayurved College,Sakkardara Chowk , Nagpur. 
Type of Sponsor  Other [Government Ayurved College,Nagpur.] 
 
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 
Prasanna Vilas Deshpande  Government Ayurved Hospital,Nagpur.  Department Of Kaychikitsa Government Ayurved College,SAkkardara Chowk Nagpur.
Nagpur
MAHARASHTRA 		 8983740167

prasannadeshpande486@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethicaln 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: J459||Other and unspecified asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kiratadi Kwath  All the patients visiting OPD, IPD and fulfilling the criteria of diagnosis and symptoms of Tamak Shvasa with special reference to Bronchial Asthma will be admitted in ward or will be treated at OPD level. The detail history of the patient will be taken as per the case record form and will be recorded. All the symptoms and investigations, will be recorded on the day of admission or at the time of visiting OPD. This day will be considered as day zero. Their status of severity will be noted. All these recorded conditions will be termed as Before Treatment. So their values will be termed as Before Treatment values. Kiratadi Kwath will be given in dose of 80ml per day divided equally in four frequencies. Follow up and assessment done as per fix schedule. Vital data will also be recorded. Particular complaints will be analysed and will be treated accordingly. Treatment will complete on 45th day and all parameters will be assessed and recorded which will be termed as After Treatment values. Investigations will also be recorded before and after treatment and this will be treated as before and after treatment scores respectively. In this series follow up will be taken after 15 days. Follow up assessment will also be done.Total duration of therapy will be 45 days. 
Comparator Agent  Tablet Deriphylline   Tablet Deriphylline will be given in dose of 150mg two times per day.Procedures and assessment will be as intervention group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Patients having sign and symptoms of tamak shvasa according to classics.
2) Patient showing symptoms, sign and medical history of bronchial asthma will be included.
3) Patients having respiratory rate in between 22 to 42 per minute will be included.
4) Patients suffering from this disease since 1 to 4 years will be included in study.
5) Patient with mild to moderate exacerbation of Bronchial asthma
6)patient willing and able to participate for 2 months.
7) Positive test of reversibility:
a] symptomatic patients - An improvement of 60 L/min or >20% in PEFR 10 min after inhalation of bronchodilator.
b] Asymptomatic patient 60 L/min or >20% fall in PEFR by provocation with 5-10 min of physical exercise followed by reversal upon inhalation of bronchodilator when assessed after 10 min.
 
 
ExclusionCriteria 
Details  1) Patients having major diseases like AIDS, renal and cardio vascular diseases will be rejected.
2) If any patient discontinues the treatment will be excluded from this study.
3) Patients with severe asthma exacerbation.
4) Patient who is pregnant or lactating will be excluded.
5) Patients with poorly controlled Hypertension [ >160/100mmhg]
6) Patients with uncontrolled Diabetes Mellitus [ Blood sugar fasting > 130 mg / dl and post meal 250 mg / dl]
7) Patients with active lung disease other than Bronchial asthma.
8) Patients who had major surgery within 2 weeks prior to screening visited.
9) Patients with a known diagnosis of human immunodeficiency virus.
10) Patients with evidence of malignancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)To evaluate the efficacy of Kiratadi Kwath in the management of Tamak Shvasa
specifically on PEFR, SMI.
2) To compare the effect of Kiratadi Kwath in trial group with Tablet Deriphylline 150 mg
in control group.
 		 1)On zero day assessments i.e B.T value.
2)For trial group Kiratadi Kwath and for control group tablet Deriphylline will be given for 45 days.
3)followed up and assessments will be done every 15 days.
4)Final assessment will be done on 45th day.
 
 
Secondary Outcome  
Outcome  TimePoints 
1)To study Tamak Shvasa in detail from Ayurvedic perspective.
2)To study Tamak Shvasa which is correlated with Bronchial asthma with modern point of view.  		 one and half year. 
 
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 
Date of First Enrollment (India)   09/04/2019 
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   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Bronchial asthma is a disease of airways that is characterized by increased hyper responsiveness of the trachea-bronchial tree to many of external stimuli. Bronchial asthma is a recurrent episodic disease of the airways that causes wheezing, shortness of breath; cough [particularly at night or early in morning]. In Ayurveda, Bronchial asthma is co-related with Tamaka Shvasa.

This project entitled “A Clinical Randomised Control Study on Efficacy of “Kiratadi Kwath” in Tamak Shvasa With Special Reference to Bronchial Asthma.”

All parameters and assessments will be based on signs and symptoms of Tamak Shvasa, PEFR and SMI.

Patients fulfilling inclusive criteria will be selected and randomisation done by computational random number generator. All these patients will be divided in two groups called as trial and control groupby lottery method followed by filling of consent form. All parameters will be assessed before and after treatment.

 
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