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CTRI Number  CTRI/2021/10/037092 [Registered on: 05/10/2021] Trial Registered Prospectively
Last Modified On: 23/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Vasa Bhavit Haridra Churnam (Haldi churn) vataja kasa (sukha khasi)w.s.r.to allergic bronchitis 
Scientific Title of Study   A Clinical Study of "Vasa Bhavit Haridra Churnam"in the management of vataja kasa w.s.r.to allergic bronchitis 
Trial Acronym  VBHC 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surendra Kumar 
Designation  MD (Ay) Scholar 
Affiliation  Government Ayurvedic College, Patna 
Address  Department of Kayachikitsa, Government Ayurvedic College, Kadamkuan, Budh murthi, Patna, Bihar 800003
Department of Kayachikitsa, Government Ayurvedic College, Kadamkua, Bhudhmurti Patna,800003
Patna
BIHAR
800003
India 
Phone  9471945936  
Fax    
Email  mryes54@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shyam Sundar Sharma 
Designation  Associate Professor, Kayachikitsa Department 
Affiliation  Government Ayurvedic College, Patna 
Address  Department of Kayachikitsa, Government Ayurvedic College, Kadamkuan, Budh murthi, Patna, Bihar 800003
Department of Kayachikitsa, Government Ayurvedic College, Kadamkua, Bhudhmurti Patna,800003
Patna
BIHAR
800003
India 
Phone  7903469075  
Fax    
Email  shyamsunder9934200515@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Surendra Kumar 
Designation  MD (Ay) Scholar 
Affiliation  Government Ayurvedic College, Patna 
Address  Department of Kayachikitsa, Government Ayurvedic College, Kadamkuan, Budh murthi, Patna, Bihar 800003
Department of Kayachikitsa, Government Ayurvedic College, Kadamkua, Bhudhmurti Patna,800003
Patna
BIHAR
800003
India 
Phone  9471945936  
Fax    
Email  mryes54@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College, Patna 
 
Primary Sponsor  
Name  Government Ayurvedic College Patna 
Address  Dr Surendra Kumar MD (Ay) Scholar Department of Kayachikitsa, Government Ayurvedic College Hospital, Kadamkua Bhudhmurti Patna 800003 
Type of Sponsor  Government medical college 
 
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 Surendra Kumar  Government Ayurvedic College Hospital  PG Department of Kayachikitsa OPD No:9, Government Ayurvedic College Hospital Patna Kadamkuan Bihar, India 800003
Patna
BIHAR 		 9471945936

mryes54@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vasa Bhavit Haridra Churnam, Reference: Sidha Bhaisajya Manimala-4guchh/15, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Cream (milk)), Additional Information: Nil
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient presenting with three or more more of the sign and symptom of of Vataja kasa.Like -
1.Shushka Kasa(Dry cough). 2.Hritparshwshool(chest pain)
3.Shirshool(Headache)
4.Swarbheda(Hoarseness)
5.Kanth ura waktra shushkta(dryness of throat,chest,mouth)
6.Daurbalya(weakness)
7.ShobhMohkruta(irritability) 
 
ExclusionCriteria 
Details  (a) Age group below 16years and above 60 year.
(b) Patients having past history of of Hematemesis,Haemoptysis,AIDS.
(c) patients with multisystem disease or who are seriously ill.
(d) Immune Compromised patients and patients on AKT
(e) Pregnancy and Lactating Mother. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Improvement in Vataja Kasa  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Vataja Kasa  7 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   11/10/2021 
Date of Study Completion (India) 28/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Kasa is one one of the the commonest complaints in day to day life and it is also a symptom of of various degrees of respiratory system. Vataja Kasa may originate due to nidan (aetiology),like dry,cold and astringent food items (vata prokopaka ahar),vegdharan(Suppression of natural Urges) and excessive physical strain(atishrama) or other course like dust smokes or pollen grains etc. In modern science cough is the most frequent symptom of respiratory disease caused by stimulation of  sensory nerve in the mucus of the pharynx,larynx,trachea and bronchi. In Siddh Bhaisajya Manimala, Acharya Mahakavi Sri krishnaram Bhatta by described that Haridra khand churna Bhavit(Ground) with Vasa swaras along with milk cream is effective in shushkta kasa (Dry cough). 
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