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CTRI Number  CTRI/2025/03/082804 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 13/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the efficacy of pippalyadi churna in the management of Allergic bronchitis 
Scientific Title of Study   A comparativw clinical study to evaluate the therapeutic effect of pippalyadi churna and sitophaladi churna in the management of kaphaja kasa VIS-A-VIS Allergic bronchitis 
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 Bhuvaneshwari 
Designation  PG scholar 
Affiliation  Muniyal institute of ayurveda medical sciences, Manipal 
Address  Outpatient department of kayachikitsa, room no.4, ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi

Udupi
KARNATAKA
576104
India 
Phone  8618641978  
Fax    
Email  shilparathod772@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pramod Shet B 
Designation  Professor 
Affiliation  Muniyal institute of ayurveda medical sciences, Manipal 
Address  Outpatient department of kayachikitsa, room no.4, ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi

Udupi
KARNATAKA
576104
India 
Phone  7204557179  
Fax    
Email  pramodshetb@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhuvaneshwari 
Designation  PG SCHOLAR 
Affiliation  Muniyal Institute Of Ayurveda Medical Science 
Address  Outpatient department of Kayachikitsa, Room no.4, Ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi

Udupi
KARNATAKA
576104
India 
Phone  8618641978  
Fax    
Email  shilparathod772@gmail.com  
 
Source of Monetary or Material Support  
Muniyal institute of ayurveda medical sciences, manipal, udupi, karnataka, India - 576104 
 
Primary Sponsor  
Name  Muniyal institute of ayurveda medical sciences 
Address  Outpatient department of kayachikitsa, room no.4, ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi, karnataka, India - 576104 
Type of Sponsor  Research institution and hospital 
 
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 Bhuvaneshwari  Muniyal institute of ayurveda medical sciences, Manipal  Outpatient department of kayachikitsa, room no.4, ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi
KARNATAKA 
8618641978

shilparathod772@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
muniyal institute of ayurveda institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J411||Mucopurulent chronic bronchitis. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Sitopaladi Churna, Reference: Charaka samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Pippalyadi churna, Reference: Gada nigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with classical symptoms of kaphaja kasa bahula, madhura, shwet snigdha, nishtiva, ghana kapha, gourava, aruchi, shirashoola, swarabheda, peenasa, utklesha, mandagni

Patients aged between 20-60 years of either gender.

Allergic bronchitis ranges from mild to moderate 
 
ExclusionCriteria 
Details  Diagnosed patients with DM/HTN

Diagnosed patients with Emphysema,CHD, Pnuemothorax, Septicemia, Haemoptysis, pneumonia, TB, Interstitial lung diseases

Pregnant women and lactating mother

Diagnosed patients with covid-19 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce the respiratory complaints  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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 3 
Date of First Enrollment (India)   15/04/2025 
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="1"
Months="3"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
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 most common diseases affecting the pranavaha srotas. If not treated, it may lead to dreadful diseases like Shwasa and Kshaya. According to the Acharyas, kasa is of 5 types, Kaphaja kasa being one among them. Kasa (cough) is the disease or symptom of respiratory tract occurring due to obstruction of Vata Dosha and its reverse movement and also a symptom of many other diseases. Kaphaja Kasa is dominated by Vata and Kapha and its nidana, samprapti, lakshanas, upadravas, and chikitsa are explainedin the classicS
The lakshanas of kaphaja kasa are similar to Allergic bronchitis or Chronic bronchitis & it has become more prevalent these days because of cigarette smoking. environmental pollution, occupational hazrds. In kaphaja kasa lakshanas are bahula, madhura, snigdha, swetha, nishtiva, ghana kapha, aruchi, gaurava, shirashoola, swarabheda, peenasa, kantha kandu, utklesha etc. Early intervention is necessary in case of kasa as it is a potential nidanarthkara vyadhi (disease itself become causative factor for other disease) to produce kshaya i.e depletion of bodily tissues/ dhatus. According to Ayurveda Chikitsa Siddhant, the prime treatment for Kaphaja Kasa is Nidana Parivarjana and the formulations which are Vata-kapha hara, Vatanulomana Agnideepana, Aama pachana and Srotoshodhaka. Keeping these points in mind an attempt is made to achieve these goals through Ayurvedic medicine. Pippalyadi churna is taken for the clinical study by considering the qualities of ingredients and cost effectiveness.
 
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