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CTRI Number  CTRI/2020/02/023651 [Registered on: 28/02/2020] Trial Registered Prospectively
Last Modified On: 30/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive
Screening 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of dry cough with ayurvedic medicine 
Scientific Title of Study   Study in the efficacy of Duhsparshadi Leha and Kantakari Avaleha in the management of Vataja Kasa 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Prabhakar Thakre 
Designation  PG Scholar 
Affiliation  OPD and IPD of Kayachikitsa Department room number 30 
Address  Datta Meghe Institute of Medical Sciences Wardha
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA
442001
India 
Phone  8308508538  
Fax    
Email  thakrepooja72@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinod Ade 
Designation  Professor 
Affiliation  MD Ayurveda 
Address  Datta Meghe Institute of Medical Sciences Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9421985018  
Fax    
Email  dr.vinodade@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pooja Prabhakar Thakre 
Designation  PG Scholar 
Affiliation  OPD and IPD of Kayachikitsa Department 
Address  Datta Meghe Institute of Medical Sciences Wardha
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA
442001
India 
Phone  8308508538  
Fax    
Email  thakrepooja72@gmail.com  
 
Source of Monetary or Material Support  
The Subjects will be recruited from Kayachikitsa OPD and IPD of Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod Hirapur Wardha and special multidiagnostic Camp 
 
Primary Sponsor  
Name  Pooja Prabhakar Thakre 
Address  Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha 442001 
Type of Sponsor  Other [self] 
 
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 
Pooja Thakre  OPD and IPD of Department Of Kayachikitsa Room No 30   Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA 		 8308508538

thakrepooja72@gmail.com 
 
Details of Ethics Committee  
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: J069||Acute upper respiratory infection,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Duhsparshadi leha   contain Yavasa Pippali Musta Bharangi Karkatshringi Kachura Puran Guda Tila Tail Dose will be 10 gm twice a day with lukewarm water before meal for 15 days 
Comparator Agent  Kantakari avaleha   contain Kantakari Guduchi Chavya Chitrak Musta Karkatshringi Pippali Sunthi Maricha Dhanvayasaka Bharangi Rasna Shati Sharkara Go-ghrita Tila tail Madhu Tugakshiri Dose will be 10 gm twice a day with lukewarm water before meal for 15 days  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient with symptom of Shushka kasa vega with duration 7 days to 1 month associated with or without Uraha-parshwashool, Shirshool and Swarbheda 
 
ExclusionCriteria 
Details  Shushka kasa associated with fever
Known case of Diabetes Mellitus Pulmonary TB Pneumonia Bronchial asthma Pleurisy excluded
Pregnant and lactating women
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief from the symptoms of urah parshwashool kasavega shirshool swarbheda by pain assesment scales and standard gradation   15 days 
 
Secondary Outcome  
Outcome  TimePoints 
absolute eosinophil count get decrease  15 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/ Phase 3 
Date of First Enrollment (India)   29/02/2020 
Date of Study Completion (India) 16/03/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 1. A Case Study on Plaque Psoriasis with Ayurvedic Management 2. Study the Efficacy of Duhsparshadi Leha and Kantakari Avaleha in the management of Vataja Kasa 3. Review on Efô€‘icacy of Herbal Antiviral Drugs against COVID-19 4. A Systematic Review on Kasa and its Management 5. Evaluation of efficacy of Navakarshik Kwath Ghan in Sheetpitta with special reference to Urticaria 6. MANAGEMENT OF AVABAHUKA THROUGH AYURVEDIC PRINCIPLE – A CASE REPORT 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This study is randomized, parallel group trial comparing the safety and efficasy of Duhsparshadi Leha 10 gm twice a day with lukewarm water before meal and Kantakari Avaleha 10 gm twice a day with lukewarm water before meal for 15 days in 30 patients (15 patient in each group) . the primary outcome will measure by gradation and secondary outcome by laboratory investigation before and after completion of treatment duration. 
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