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CTRI Number  CTRI/2025/03/082931 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 03/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To see the effect of Ayurvedic Formulation in Hypertension in Obese Patients  
Scientific Title of Study   A single arm single clinical study to evaluate the efficiency of Ayurvedic Formulation in the management of Hypertension in Obese Patients  
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 Sanket Thengle  
Designation  MD Scholar Kayachikitsa  
Affiliation  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune  
Address  Department of Kayachikitsa,OPD No-5 Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune Maharashtra

Pune
MAHARASHTRA
411018
India 
Phone  9579421729  
Fax    
Email  thenglesanketh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhijit Shekhar  
Designation  Assistant Professor MD Kayachikitsa  
Affiliation  Dr D Y Patil College of Ayurved and Research Centre  
Address  Department of kayachikitsa, OPD no 5, Dr D Y Patil College of Ayurved Research Centre Pimpri Pune Maharashtra

Pune
MAHARASHTRA
411018
India 
Phone  9764546495  
Fax    
Email  abhijitshekhar00@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhijit Shekhar  
Designation  Assistant Professor MD Kayachikitsa  
Affiliation  Dr D Y Patil College of Ayurved and Research Centre  
Address  Department of kayachikitsa, OPD no 5, Dr D Y Patil College of Ayurved Research Centre Pimpri Pune Maharashtra

Pune
MAHARASHTRA
411018
India 
Phone  9764546495  
Fax    
Email  abhijitshekhar00@gmail.com  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil College of Ayurved and Research Centre , Sant Tukaram Nagar, Pimpri, pune, Maharashtra 411018 
 
Primary Sponsor  
Name  Dr Sanket Thengle  
Address  Department of kayachikitsa, OPD no 5, Dr D Y Patil College of Ayurved Research Centre Sant Tukaram Nager Pimpri Pune MAHARASHTRA 411018 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 Sanket Thengle  Dr. D. Y. Patil College of Ayurved and Research Centre , Pimpri, Pune  OPD No.5 and IPD of Kayachikitsa Department Dr. D. Y. Patil Ayurved College and Research Centre, Sant Tukaram Ngae, Pimpri, Pune-411018, Maharashtra
Pune
MAHARASHTRA 		 9579421729

thenglesanketh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.DYPCA & RC Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I119||Hypertensive heart disease withoutheart failure. Ayurveda Condition: HRUDROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Ayurvedic formulation , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water ), Additional Information: Ayurvedic formulation (content)of 1 tablet (500 mg)- Guggul-250 mg, Triphala -50 mg,Trimad-50 mg,Vrikshyaamla phalaras-20 ml,Pushkarmoola-40 mg,Bhrahmi-40 mg,gokshura-20 mg, Ajvayan -10 mg,Ela-20mg,shunthi-20 mg,Dadimphalaras-15 ml
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age 18 to 70 years
Systolic Blood pressure more than or equal to 140 mmHg to less than or equal to 180 mmHg
Diastolic Blood pressure more than or equal to 90 mmHg to less than or equal to 110 mmHg(WHO)
Body mass index (BMI) greater than or equal to 30 kg/m2 (WHO)
 
 
ExclusionCriteria 
Details  Accelerated and malignant hypertension.
Symptomatic patient with clinical feature of early heart failure.
Known history of hemorrhagic stroke.
Pregnant and lactating mother.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in Blood Pressure as well as Body Mass Index.
 		 15th and 30th day
 
 
Secondary Outcome  
Outcome  TimePoints 
The symptoms of Obesity induced Hypertension will be reduce  15th and 30th day 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/04/2026 
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 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  

The aim of the study is to see the efficacy of ayurvedic formulation as an add on drug in the  management of hypertension in obese patient. The study will be conducted on 35 patients having signs and symptoms of hypertension in obese patient. 2 tablets of 500mg will be given twice in a day along with luke warm water  before food for the duration of 30 days and follow up will be done on 15th and 30th day and final conclusion will be drawn on the basis of statistical methods.

 
 
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