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CTRI Number  CTRI/2025/03/081762 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 04/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the Effect of Shrungyadi Churna and Sitopaladi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia  
Scientific Title of Study   A Randomized Comparative Clinical Study to Evaluate the Effect of Shrungyadi Churna and Sitopaladi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bindu M N  
Designation  PG Scholar Kayachikitsa 
Affiliation  BVVS Ayurved Medical College and Hospital, 
Address  Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101

Bagalkot
KARNATAKA
587101
India 
Phone  9686363503  
Fax    
Email  bindumnbindu4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr sunil kumar M Chabanur 
Designation  Professor and HOD 
Affiliation  BVVS Ayurved Medical College and Hospital, 
Address  Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101

Bagalkot
KARNATAKA
587101
India 
Phone  9740878703  
Fax    
Email  drsunilkumar09@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sunil kumar M Chabanur 
Designation  Professor and HOD 
Affiliation  BVVS Ayurved Medical College and Hospital, 
Address  Department of PG Studies in Kayachikitsa BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101

Bagalkot
KARNATAKA
587101
India 
Phone  9740878703  
Fax    
Email  drsunilkumar09@gmail.com  
 
Source of Monetary or Material Support  
BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101 
 
Primary Sponsor  
Name  BVVS Ayurved Medical College and Hospital 
Address  BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101 
Type of Sponsor  Private 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 Bindu M N  BVVS Ayurved Medical College and Hospital  Departmet of PG studied in Kayachikitsa BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka 587101 India
Bagalkot
KARNATAKA 
9686363503

bindumnbindu4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECBVVSAyurvedMedicalCollegeandHospital BagalkotKarnataka  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. Ayurveda Condition: VATAJAKASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shrungyadi Churna , Reference: Gadanigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Sitopaladi Churna , Reference: Charaka samhita chikitsa sthana Rajayakshma chikitsa adhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria :
1.Patients having classical signs and symptoms of Vataja Kasa with duration of 3 to 7 days.
2.Patients between age group 18 - 60 years of either sex.
3.Patients presenting with Absolute Eosinophilia Count more than 440 cells/cumm in the peripheral blood smear.  
 
ExclusionCriteria 
Details  Exclusion criteria :
1.Patients with other disorders of Respiratory System.
2. Patients with DM and uncontrolled Hypertension.
3.Pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know the efficacy of Shrungyadi Churna and Sitopaladi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Aims and Objectives of the study :
1. To compare the efficacy of Shrungyadi Churna and Sitopaladi Churna in Vataja Kasa with special reference to Simpe Pulmonary Eosinophilia
2. To study the efficacy of Shrungyadi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia
3. To study the efficacy of Sitopaladi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia. 
7 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/04/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Kasa is one of the disease mentioned in Pranavaha Srotovikara. Vataja Kasa is one among the 5 types of Kasa where Shushka Kasa is a prominent symptom. Prana and Udana Vayu are responsible for normal functioning of Pranavahasrotas which can be altered due to causative factors like Raja and Dhuma. When Adhogati of Vata is obstructed by Dushta Doshas it attains the Urdwa Gati and takes Sthanasamshraya in Urapradesha and produces Kasa
         Incidence of Kasa has been increased due to continuous exposure of the respiratory system to the external environment affected by pollutants, allergens, smoke, dust, air pollution, occupational risks, industrialization and population explosion with an influence of modern life style. The prevalence of cough was found to be between 2.4 to 5.6 percent in the rural areas and 1.7 to 5.4 percent in urban areas in different centers of India.

       Vataja Kasa presents with symptoms like Shushka Kasa, Hruth-Parshva-Shirashula,Ura-Kanta-Vaktra-Shushkata, Swarabheda, and Dourbalya .Based on similar signs and symptoms Vataja Kasa can be compared with ‘’Simple Pulmonary Eosinophilia.’’It is the most common form of Eosinophilic lung disease. Simple Pulmonary Eosinophilia affects males and females in equal number. It is characterized by chest pain, dry cough which may be associated with little amount of sputum, paroxysmal cough, headache, feeble voice and general weakness.

       Management of non productive respiratory condition include antitussive alone or in combination of anti histamines, decongestants which have their own limitation and side effects. In classics Nidana Parivarjana, Shodana, Shamana, Rasayana with special importance for the use of Vata Anulomana Aushadi Prayoga in the management of Vataja Kasa has been explained.

      Shrungyadi Churna  is mentioned in Gadanigraha and Sitopaladi Churna is mentioned in Charaka Samhita, Chikitsa Sthana, Rajayakshma Chikitsa. Shrungyadi Churna contains Karkataka Shrungi, Vacha, Katphala, Katruna, Musta, Abhaya , Dhanyaka, Bringaraja, Devadaru, and Hingu. All are having Katu, Tikta, Kashaya Rasa, Laghu Ruksha Guna and Ushna Veerya acts as Vata Kaphahara, Deepana, Pachana, Vata Anulomana and Kasahara. Sitopaladi Churna contains Sitopala, Vamshalochana, Pippali, Ela, Twak. Among them Sitopala and Vamshalochana are having Madhura Rasa, Laghu Snigdha Guna and Sheeta Veerya which helps in Vata-Pitta Shamana. Pippali, Ela, Twak are having Katu Rasa, Laghu Ruksha Guna, Ushna Veerya acts as Vata Kaphahara and Vata Anulomana.
            Considering above points present study will be aimed to evaluate and compare the efficacy of Shrungyadi Churna and Sitopaladi Churna in Vataja Kasa with special reference to Simple Pulmonary Eosinophilia.
 
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