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CTRI Number  CTRI/2022/09/045874 [Registered on: 26/09/2022] Trial Registered Prospectively
Last Modified On: 22/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   TREATMENT OF BRONCHIAL ASTHMA (TAMAKA SHWASA)THROUGH AYURVEDA 
Scientific Title of Study   CLINICAL EVALUATION OF SINGHYADI KWATHA IN THE MANAGEMENT OF TAMAKA SWASA (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  Dr SUMIT PRAJAPAT 
Designation  P G SCHOLAR  
Affiliation  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEACRH JODHPUR 
Address  P G DEPARTMENT OF KAYACHIKITSA UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH, JODHPUR RAJASTHAN

Jodhpur
RAJASTHAN
342037
India 
Phone  7976367461  
Fax    
Email  sumitprajapat1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr PRAMOD KUMAR MISHRA 
Designation  PROFESSOR AND HOD 
Affiliation  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH JODHPUR  
Address  P G DEPARTMENT OF KAYACHIKITSA UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH,Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY, JODHPUR RAJASTHAN

Jodhpur
RAJASTHAN
342037
India 
Phone  9001009793  
Fax    
Email  drpramodmishra4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SUMIT PRAJAPAT 
Designation  P G SCHOLAR  
Affiliation  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH JODHPUR  
Address  P G DEPARTMENT OF KAYACHIKITSA UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH, Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY, JODHPUR RAJASTHAN

Jodhpur
RAJASTHAN
342037
India 
Phone  7976367461  
Fax    
Email  sumitprajapat1994@gmail.com  
 
Source of Monetary or Material Support  
UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH JODHPUR  
 
Primary Sponsor  
Name  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH JODHPUR RAJASTHAN  
Address  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH, Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY,JODHPUR, RAJASTHAN, 342037 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr SUMIT PRAJAPAT  P G DEPARTMENT OF KAYACHIKITSA, UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH, Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY, JODHPUR, RAJASTHAN, 342037 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SUMIT PRAJAPAT  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH JODHPUR RAJASTHAN   P G DEPARTMENT OF KAYACHIKITSA (OPD NO 4), UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH, Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY, JODHPUR, RAJASTHAN, 342037
Jodhpur
RAJASTHAN 		 7976367461

sumitprajapat1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE OF ETHICS COMMITTEE, UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH JODHPUR RAJASTHAN   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. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: SINGHYADI KWATHA , Reference: YOGA RATNAKAR (SWASA PRAKARAN), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.PATIENTS HAVING CHRONICITY BELOW 10 YEARS
2. PATIENTS WHO ARE PRESENTING WITH CLINICAL FEATURES OF TAMAKA SWASA (BRONCHIAL ASTHMA OR ALLERGIC BRONCHIAL ASTHMA) LIKE, BREATHLESSNESS, WHEEZE, PAROXYSM OF ATTACK, COUGH ETC. IRRESPECTIVE OF SEX AND RELIGION 
 
ExclusionCriteria 
Details  a) Age below 10 and above 70 years.
b) Patients having asthma due to secondary causes
such as drug induced like aspirin.
c) Pregnant women and lactating mothers.
d) Systemic illness like Tuberculosis, Carcinoma,
Endocrine disorders
e) Patient having Clinical Features of CCF.
f) Patient having the major renal or liver
disorders.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of Singhyadi Kwatha in the management of Tamaka Shwasa of various etiological factors.  45 DAYS for each patients and completion of trial within 6 months from the date of starting of trial (1st October 2022)
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety, sustainability and adverse drug reaction of trial drug.  45 DAYS 
 
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 2/ Phase 3 
Date of First Enrollment (India)   01/10/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The disease Tamaka Swasa is predominantly caused by Pranavaha Sroto Dushti and in its pathogenesis; Pratiloma Gati of Vata plays an important role along with Srotorodha produced by Kapha. Tamaka Swasa is developed by some Vata and Kapha Prakopaka Aahara and Vihara. In one of the pathogenesis of Swasa, Vata is in normal state and Kapha is vitiated with its own etiological factors and this vitiated Kapha in the Uraha Pradesha causes the obstruction in the normal path of Vata (Prana).
Asthma is one of the most common chronic diseases among children worldwide. According to globalasthmareport.org among India’s 1.31 billion people, about 6% of children and 2% of adults have asthma as reported in 2018. Asthma affected an estimated 262 million people in 2019 and caused 461 000 deaths. By the year 2020, asthma along with COPD will become the third leading cause of death. Treatment and effective management of asthma saves lives.
In Ayurveda there is effective treatment of asthma and Ayurveda can do a lot on this global disease “Bronchial Asthma” described as “Tamaka Swasa”. In Ayurvedic literature, numbers of herbal preparations are described for the management of Tamaka Swasa.
Drugs which are being used as contents of the ‘Singhyadi Kwatha’ are rich in properties (Guna) of Kaphaghna, Swasahara, Kaphanissaraka, Kasahara, Shothhara, Hikkanigrahana, Vedanashamaka, Broncho dilatory and antihistaminic effects.
In a view of above study to know the aetiopathogenesis of Tamaka Swasa, To evaluate the efficacy, safety, sustainability & adverse drug reaction of a trial drug.
 
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