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CTRI Number  CTRI/2024/09/074251 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 14/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   efficacy of punarnavadi vati in the management of sthaulya with special reference to dyslipidemia in hypertension. 
Scientific Title of Study   Prospective single arm open clinical trial to evaluate the efficacy of Punarnavadi Vati in the management of Sthaulya with special reference to Dyslipidemia in Hypertension. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shweta Santosh Shirsath 
Designation  PG Scholar 
Affiliation  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara 
Address  PG department of kayachikitsa, Dr M N Aagashe Aryangala hospital, Shukravar Peth, Satara Seth Chandanmal Mutha aryangla Vaidyak Mahavidyalaya, Satara Gendamal, ITI road, Shahupuri, Satara.

Satara
MAHARASHTRA
415002
India 
Phone  8830620932  
Fax    
Email  shirsathshweta8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sameer Prahlad Shinde 
Designation  Associate Professor of Kaychikitsa 
Affiliation  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara 
Address  PG department of kayachikitsa, cabin no.2, Dr M N Agashe Aryangala hospital, Shukravar Peth Seth Chandanmal Mutha aryangla Vaidyak Mahavidyalaya, Satara Gendamal, ITI road, Shahupuri, Satara.

Satara
MAHARASHTRA
415002
India 
Phone  7507043414  
Fax    
Email  sameershubha85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shweta Santosh Shirsath 
Designation  PG Scholar 
Affiliation  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara 
Address  PG department of kayachikitsa, Dr M N Agashe Aryangala hospital, Shukravar Peth, Satara Seth Chandanmal Mutha aryangla Vaidyak Mahavidyalaya, Satara Gendamal, ITI road, Shahupuri, Satara.

Satara
MAHARASHTRA
415002
India 
Phone  8830620932  
Fax    
Email  shirsathshweta8@gmail.com  
 
Source of Monetary or Material Support  
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalay Satara, Gendala, ITI road, shahupuri satara pin 415002 
 
Primary Sponsor  
Name  Dr Shweta Santosh Shirsath 
Address  PG department of kayachikitsa Seth chandanmal mutha aryangal vaidyak mahavidyalaya satara, gendamal ITI road, shahupuri, satara, pin 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 Shweta Santosh Shirsath  Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara,  room no4 OPD block department of kayachikitsa Dr m n aagashe aryangla hospital satara, maharashtra satara
Satara
MAHARASHTRA 		 8830620932

shirsathshweta8@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:E669||Obesity, unspecified. Ayurveda Condition: STHUL,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: punarnavadi vati, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 efficacy of punarnavadi vati in the management of sthaulya with special reference to dyslipidemia in hypertension.
2 Patients from age group of 18 to 60years irrespective of gender, religion, socio-economic status, marital status.
2 Patients of Sthaulya with hypertension as per signs and symptoms BMI between 25 to 34. Including overweight Obese class 1 as per signs and symptoms mentioned in Ayurvedic Samhitas.
3 Waist To hip Ratio more than 1.
4 Patient with known case of HTN
Systolic BP should be less than 160
Diastolic BP should be less than 100 
 
ExclusionCriteria 
Details  1 Pregnant and lactating women.
2
Acute life threatening conditions like CVA, CA, Acute MI, DM I and Insulin Dependent.
3
Known Cases of Hypothyroidism and hyperthyroidism.
4
Patient with Systolic BP more than 160 diastolic BP more than 99 
 
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 Punarnavadi Vati In Sthaulya with special reference to Dyslipidemia in Hypertension.  15th and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
1 To evaluate the efficacy of Punarnavadi Vati in Sthaulya with special reference to dyslipidemia in HTN.
2 To study the etiopathology of Sthaulya and Dyslipidemia
3 To study the of ingredients of Punarnvadi vati
4 To evaluate any adverse effect of Punarnvadi Vati if any.
5 To study the efficacy of Punarnavadi vati in blood pressure. 		 30 days 
 
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)   25/09/2024 
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)  		 Open to Recruitment 
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

  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 [shirsathshweta8@gmail.com].

  6. For how long will this data be available start date provided 09-07-2024 and end date provided 12-07-2029?
    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 - nill
Brief Summary   single arm open clinical trial
this study is conducting for To evaluate the efficacy of Punarnavadi Vati In Sthaulya with special reference to Dyslipidemia in Hypertension.

Total 30 patients of Sthaulya with hypertension who fulfils inclusion criteria and showing signs and symptoms will Be taken from OPD and IPD of concerned institute. Written information consent will be taken in native language.
Various epidemiological studies have shown the prevalence of the co-existence of dyslipidemia with hypertension in the range of 15 to 31% and Prevalence in Maharashtra is 34%. As per modern science sthaulya sings and symotoms resembles with dyslipidemia, It is characterised by abnormal level of lipids.

Null Hypothesis 
Punarnavadi vati 500mg orally four tablets twice a day for 30 days is not effective in sthaulya with special reference to Dyslipidemia in HTN

Alternative Hypothesis
Punarnavadi vati 500mg orally four tablets twice a day for 30 days is not effective in sthaulya with special reference to Dyslipidemia in HTN

Drug- Punarnavadi Vati
Dose- 500mg 4 tablets twice a day
Anupana- koshna jala
Sevankala : Bhojanpashchat
Duration : 30 Days
Ahara(Diet) : As per pathyakara Ahara mentioned in Ayurvedic texts.
Vihara : As per pathyakara Vihara mentioned in Ayurvedic texts






 
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