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CTRI Number  CTRI/2023/06/054158 [Registered on: 20/06/2023] Trial Registered Prospectively
Last Modified On: 15/06/2023
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of Paarthadi Kwath along with Hridbasti compared with Calcium channel blocker in Essential Hypertension. 
Scientific Title of Study   A Comparative clinical study to evaluate the efficacy of Paarthadi Kwath along with Hridbasti and calcium channel blocker on Essential 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 Abhijit Dinkarrao Shekhar  
Designation  Assistant Professor 
Affiliation  Dr. D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 
Address  Dr. D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9764546495  
Fax    
Email  abhijitshekhar00@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhijit Dinkarrao Shekhar  
Designation  Assistant Professor 
Affiliation  Dr. D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 
Address  Dr. D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9764546495  
Fax    
Email  abhijitshekhar00@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhijit Dinkarrao Shekhar  
Designation  Assistant Professor 
Affiliation  Dr. D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 
Address  Dr. D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9764546495  
Fax    
Email  abhijitshekhar00@gmail.com  
 
Source of Monetary or Material Support  
DPU Seed Money with letter no. DPU-644/34/2021 
 
Primary Sponsor  
Name  DPU Seed Money with letter no DPU  
Address  Dr. D Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune PIN- 411018 
Type of Sponsor  Research institution and hospital 
 
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 Abhijit Dinkarrao Shekhar  Dr. D Y Patil College of Ayurved and Research Centre  OPD No. 5, Kayachikitsa Department, Ground Floor, Dr. D Y Patil College of Ayurveda and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA 		 9764546495

abhijitshekhar00@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Paarthadi kwath, Reference: Anukta Yoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Tab. Stamlo 2.5mgRoute- Oral, Dose- 2.5mg, Frequency- OD (Before Food), Duration- 7 Days
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  1. 18-70 years of either gender.
2. Systolic Blood pressure less than 170mmHg more than or equal to 140mmHg.
3. Distolic Blood Pressure less thann or equal to 110mmHg and more than 90mmHg.
4. Hypertension Stage II according to JNC seventh report 2004. 
 
ExclusionCriteria 
Details  1. Patient that past history of atrial fibrillation, acute coronary syndrome ,myocardial infarction, stroke, right ventricular hypertrophy, left ventricular hypertrophy, severe arrhythmia in last 6 months.
2. Symptomatic patient with clinical feature of early heart failure.
3. Secondary hypertension.
4. Patient with concurrent serious hepatic dysfunction, renal dysfunction, uncontrolled pulmonary dysfunction.
5. Patient suffering with diabetes nephropathy.
6. Women who are pregnant, lactating or on estrogen replacement therapy.
7. Alcohol and Drug abusers.
8. Accelerated and maligant hypertension. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patient showing relief from clinical sign and symptoms of essential hypertension.  0, 4 and 7 day 
 
Secondary Outcome  
Outcome  TimePoints 
To complete seven days treatment  0, 4 and 7 day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="20" 
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)   01/07/2023 
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   none 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A group of 20 patients will get Paarthadi Kwath along with Hridbasti for a period of 7 days. Another group of 20 patients will get Tab. Stamlo 2.5mg for 7 days. Data will be collected and compared. 
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