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CTRI Number  CTRI/2024/07/071159 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of JAYADI VATI in the management of Viral Fever. 
Scientific Title of Study   Prospective Single Arm Open clinical Trial To Study The Efficacy Of Jayadi Vati In The Management Of Vat Khaphaj Jwara With Special Reference To Acute Viral Fever. 
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 Ketali Suresh Chougule 
Designation  PG Scholar 
Affiliation  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara 
Address  PG Department of Kayachikitsa, M N Agashe , Aryangla Hospital, Shukrawar peth, Satara 415002
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Gendamal, ITI road, Shahupuri, Satara, 415002
Satara
MAHARASHTRA
415002
India 
Phone  8459450503  
Fax    
Email  ketalichougule@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P D Londhe 
Designation  Professor and HOD  
Affiliation  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara 
Address  Cabin no. 1 , PG Department of Kayachikitsa , Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Gendamal, ITI road, Shahupuri, Satara, 415002
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Gendamal, ITI road, Shahupuri, Satara, 415002
Satara
MAHARASHTRA
415002
India 
Phone  9422435765  
Fax    
Email  drpdlondhe4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ketali Suresh Chougule 
Designation  PG Scholar 
Affiliation  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara 
Address  PG Department of Kayachikitsa, M N Agashe Aryangla Hospital, shukrawar peth, Satara 415002
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Gendamal, ITI road, Shahupuri, Satara, 415002
Satara
MAHARASHTRA
415002
India 
Phone  8459450503  
Fax    
Email  ketalichougule@gmail.com  
 
Source of Monetary or Material Support  
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,Gendamal,ITI road Satara,Maharashtra, India 415002 
 
Primary Sponsor  
Name  Dr. Ketali Suresh Chougule  
Address  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Gendamal, ITI road, Shahupuri, Satara, 415002 
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 P D Londhe  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara,  Room no.4,OPD Block, M N Aagashe Aryangla Hospital, Shukrawar Peth, Satara, 415002
Satara
MAHARASHTRA 		 9422435765

drpdlondhe4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SCM Aryangla Vaidyak Mahavidyalay Satara  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J111||Influenza due to unidentified influenza virus with other respiratory manifestations. Ayurveda Condition: JVARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: JAYADI VATI, Reference: Rasendrasar sangrah jwara chikitsa /16, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: koshna jal), Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient presenting with pratyatma lakshan of Vat Khaphaj Jwara (Acute Viral Fever). 
 
ExclusionCriteria 
Details  1 patients having temperature more than 101f
2 Pregnant and Lactating women.
3 patients with systemic disorders like Malignancy, TB, Pneumonia, Asthma COPD, Tumors of Lung, Plural Effusion
4 patients suffering from Cardiovascular diseases like Hypertension ,CAD, Cardiomyopathy 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the efficacy of Jayadi Vati in reduction of body temperature in Jwara.
 		 7 days
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate the efficacy of Jayadi Vati in reduction of body temperature in Jwara.
 		 3rd & 7th day 
2.To study the adverse effects of Jayadi vati, if any.  3rd & 7th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   07/08/2024 
Date of Study Completion (India) 30/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [ketalichougule@gmail.com].

  6. For how long will this data be available start date provided 07-07-2024 and end date provided 07-12-2028?
    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
Modification(s)  		 Current clinical trial is titled as " Prospective Single Arm Open Clinical Trial To Study The Efficacy Of Jayadi Vati In The Management Of Vat Kaphaj Jwara With Special Reference To Acute Viral Fever."
The trial drug used in this clinical study is Jayadi Vati which will be given in the dose 250mg thrice a day for 7 days.
The sample size of this study will be 30.
It is single arm prospective open clinical trial.
The patient will be selected from OPD and IPD of our concerned institute.
The purpose of this trial is to assess the efficacy of Jayadi Vati.
The Null hypothesis for this trial is - Jayadi vati of 250mg orally thrice a day is not effective in the management of vat kaphaj jwara with special reference to acute viral fever.
The Alternative hypothesis for this trial is - jayadi vati of 250mg orally thrice a day is effective in the management of vat kaphaj jwara with special reference to acute viral fever. 
Observation and Results - 
Above clinical research study in 30 patients of Vat Kaphaj Jwara w.s.r to Acute Viral Fever with Jayadi Vati shows following results 
In subjective criteria it is evident that total no of patients shows 71.62 %relief in Santap, 68.63 % relief in Parvaruka, 67.57% relief in Kas, and 68.09% relief in Pratishyay. 
In Objective criteria for Hb and TLC there was statistically no significant difference seen for values between the time interval, so there is no significant change observed in Hb and TLC. Where for ESR, CRP and Urine Pus cells, there was statistically high significant difference seen for values between the time interval. 
The total efficacy of Jayadi vati in management of vat kaphaj jwara w.s.r to Acute Viral Fever is marked ie 75-99 % in 26 patients, Moderate i.e 50-75 % in 3 patients and Mild i.e 25-50 % in 1 patient. 
Conclusion - 
Based on P value, it can be concluded that the Null Hypothesis is rejected and the Alternative Hypothesis can be retained, indicating that JAYADI VATI is effective in the management of Vat Kaphaj Jwara w.s.r to Acute Viral Fever. 
There is no noticeable adverse effects of the drug observed during the treatment period. Jayadi Vati is clinically safe and effective preparation that does not have any side effects in managing Vat Kaphaj Jwara when combined with proper Pathya and Aahar-Vihar. 



 
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