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CTRI Number  CTRI/2024/11/077329 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Padmakadi Avaleha in Bronchitis 
Scientific Title of Study   Prospective Single Arm Open Clinical Trial To Study The Efficacy Of Padmakadi Avaleha In Management Of Kaphaja Kasa With Special Reference To 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 Supriya Maruti Ghorpade 
Designation  PG Scholar 
Affiliation  Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara 
Address  PG department of kayachikitsa,Dr M N Agashe Aryangla Hospital Shukravarpeth Satara,Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,ITI road Gendamal Satara

Satara
MAHARASHTRA
415002
India 
Phone  9421964008  
Fax    
Email  ghorpadesupriya434@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P D Londhe 
Designation  HOD and Professor of Kayachikitsa 
Affiliation  Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara 
Address  PG department of kaychikitsa Cabin no 1,Dr M N Agashe Aryangla Hospital Shukravarpeth Satara,Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,ITI road Gendamal Satara

Satara
MAHARASHTRA
415002
India 
Phone  8830783292  
Fax    
Email  drpdlondhe4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Supriya Maruti Ghorpade 
Designation  PG Scholar 
Affiliation  Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara 
Address  PG department of Kayachikitsa,Dr M N Agashe Aryangla Hospital Shukravarpeth Satara,Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya ITI road ,Gendamal satara

Satara
MAHARASHTRA
415002
India 
Phone  9421964008  
Fax    
Email  ghorpadesupriya434@gmail.com  
 
Source of Monetary or Material Support  
Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya ,ITI road Gendamal Satara 415002 
 
Primary Sponsor  
Name  Dr Supriya Maruti Ghorpade 
Address  PG department of Kayachikitsa ,Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya ,ITI road Gendamal Satara 415002, Maharashtra, India. 
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 
Dr Supriya Maruti Ghorpade  Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara  Room no 4 OPD block department of kayachikitsa , Dr M N Agashe Aryangla Hospital Satara
Satara
MAHARASHTRA 		 9421964008

ghorpadesupriya434@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SCM Aryangla Vaidyak Mahavidyalaya Satara  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J40||Bronchitis, not specified as acuteor chronic. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Padmakadi Avaleha, Reference: Charak Chikitsasthan, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: Nil-
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Patients presenting with symptoms of Kaphaja kasa (Bronchitis) with kasa Vega (Bouts of cough),Kapha Nishthivan(Sputum Production),Shwaskrichata(Breathlessness),Urashool(Chest pain while coughing),Peenas(Common cold),Aruchi(Tasteless)as described in Ayurvedic Classics
2)Patients age between 18yrs to 70yrs of either sex
3)Patients without any bar of caste,religion, occupation, socioeconomic status  
 
ExclusionCriteria 
Details  1)Patients with known case of TB, Lung Cancer, Interstitial Lung Disease, Pneumonia, Pneumothorax
2)Patients with serious illness like HIV, Malignancy, Severe Cardiac Disease, Uncontrolled DM,Hepatic Disorder, Stroke, Arrhythmia or Evidence of Heart Failure and Auto Immune Disorder
3)Pregnant Women and Lactacting Mother 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Padmakadi Avaleha in Kaphaja Kasa.  7th day and 14th day 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate any adverse effects of Padmakadi Avaleha in Kaphaja Kasa if any.
 		 7th day and 14th day 
 
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 3 
Date of First Enrollment (India)   06/12/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ghorpadesupriya434@gmail.com].

  6. For how long will this data be available start date provided 20-11-2024 and end date provided 20-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Single arm open Clinical Trial

This study is conducting for evaluate efficacy of Padmakadi Avaleha in management of Kaphaja Kasa with special reference to Bronchitis. 
After screening patients at OPD and IPD level 30 patients will be selected for trial , informed written consent will be taken in native language.
Kaphaja Kasa often best compared with bronchitis due to similarities of sign and symptoms. According to estimate from National Interview taken by National Center for Health Statistics 9.5 Million or 4% of population were diagnosed with Bronchitis. According to Pub Med Central Article, latest prevalence rate of bronchitis varies throughout the world from 3.4% - 22% in general population.

Null Hypothesis
Padmakadi Avaleha 10 gm orally twice a day for 14 days is not effective in Kaphaja Kasa with special reference to Bronchitis.

Alternate Hypothesis
Padmakadi Avaleha 10 gm orally twice a day for 14 days is effective in Kaphaja Kasa with special reference to Bronchitis.

Drug - Padmakadi Avaleha 
 
Dose - 10 gm twice a day

Anupana - Koshna Jala

Sevan Kala - Vyanodana (After Food)

Duration - 14 Days

Follow up - 7th day and 14th Day


 
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