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CTRI Number  CTRI/2026/02/103013 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 04/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of chaturbhadra leha in Cough 
Scientific Title of Study   Prospective single arm open clinical trial to study the efficacy of chaturbhadra leha in management of kaphaja kasa with special reference to URTI 
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 Bhakti Pramod Meru 
Designation  PG Scholar 
Affiliation  Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,Satara 
Address  PG Department of kayachikitsa Dr M N Agashe Aryangla Hospital Shukrawar Peth Satara SCM AVM Gendamal Satara Satara MAHARASHTRA

Satara
MAHARASHTRA
415002
India 
Phone  8788610898  
Fax    
Email  bhaktimeru@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 Mahavidyalya,Satara 
Address  PG Department of kayachikitsa cabin no 1 Dr M N Agashe Aryangla Hospital Shukrawar Peth Satara SCM AVM Gendamal satara MAHARASHTRA

Satara
MAHARASHTRA
415002
India 
Phone  8830783292  
Fax    
Email  drpdlondhe4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhakti Pramod Meru 
Designation  PG Scholar 
Affiliation  Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,Satara 
Address  PG Department of kayachikitsa Dr M N Agashe Aryangla Hospital Shukrawar Peth Satara SCM AVM gendamal Satara MAHARASHTRA

Satara
MAHARASHTRA
415002
India 
Phone  8788610898  
Fax    
Email  bhaktimeru@gmail.com  
 
Source of Monetary or Material Support  
Seth Chandamal Mutha Aryangla Vaidyak Mahavidyalaya ITI Road Gendamal Satara 415002 
 
Primary Sponsor  
Name  Dr Bhakti Pramod Meru 
Address  PG Department of kayachikitsa SCM AVM ITI road gendamal Satara 
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 Bhakti Pramod Meru  sheth chandanmal mutha aryangla vaidyak mahavidyalaya satara   room no 4 opd block department of kayachikitsa dr m n agashe aryngla hospital satara
Satara
MAHARASHTRA 		 8788610898

bhaktimeru@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:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Chaturbhadra Leha, Reference: Chakradutta Jwara Chikitsa 109/10, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  patients presenting with symptoms of kaphaja kasa with kasa veg kapha nishthivan kanthshool angamrda jwara
patients age between 18 to 70 yrs of either sexes  
 
ExclusionCriteria 
Details  patients with known case of TB lung cancer interstitial lung disease pneumonia pneumothorax copd
patients with severe illness like HIV malignancy uncontrolled DM arrhythmia autoimmune disorder
pregnant women and lactating mothers 
 
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 chaturbhadra leha in kaphaj kasa  7th and 14th day 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate adverse effect of chaturbhadra Leha in kaphaja kasa if any  7th day and 14th day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/03/2026 
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)   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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  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 [bhaktimeru@gmail.com].

  6. For how long will this data be available start date provided 18-03-2028 and end date provided 18-03-2033?
    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   This is single arm open clinical trial
This study is being conducted to evaluate efficacy of chaturbhadra leha in management of kaphaj kasa with special reference to URTI
After screening patients at opd and ipd level 50 patients will be selected  for trial informed written consent will be taken in native language
kaphaja kasa often best compared with urti due to similarities of signs and symptoms  The prevalence rate of urti varies in india but in study 2022 found that among adults aged 14 to 59 the incidence was 21%
Null Hypothesis 
chaturbhadra leha 2 gm orally twice a day for 14 days is not significantly effective in kaphaja kasa with special reference to urti
Alternative Hypothesis
chaturbhadra leha 2 gm orally twice a day for 14 days is significantly effective in kaphaja kasa with special reference to urti
Drug - chaturbhadra leha
Dose—2 gm twice a day
Anupana - Koshna Jala
Sevan kala- Vyanodan 
Duration - 14 days
Follow up - 7th and 14th days
 
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