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CTRI Number  CTRI/2025/03/081967 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 26/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of High Blood Pressure with purgation therapy by using Aragwadhadi Avaleha  
Scientific Title of Study   Clinical Evaluation of Virechan Karma of Aragwadhadi Avaleha in the Management of Hypertension 
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 Bidushi Mishra 
Designation  PG Scholar 
Affiliation  Bharati Vidyapeeth College Of Ayurved Pune 
Address  OPD number 21 Ground floor Department of Panchakarma College of Ayurved Bharati Vidyapeeth Pune Satara Road Dhankwadi Campus

Pune
MAHARASHTRA
411043
India 
Phone  9827430093  
Fax    
Email  bidushi.mishra-ayurved@bvp.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Santosh E Chavan 
Designation  Professor and Head of Department Panchakarma 
Affiliation  Bharati Vidyapeeth College Of Ayurved Pune 
Address  OPD number 21 Ground floor Department of Panchakarma College of Ayurved Bharati Vidyapeeth Pune Satara Road Dhankwadi Campus

Pune
MAHARASHTRA
411043
India 
Phone  9822249807  
Fax    
Email  santosh.chavan@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Santosh E Chavan 
Designation  Professor and Head of Department Panchakarma 
Affiliation  Bharati Vidyapeeth College Of Ayurved Pune 
Address  OPD number 21 Ground floor Department of Panchakarma College of Ayurved Bharati Vidyapeeth Pune Satara Road Dhankwadi Campus


MAHARASHTRA
411043
India 
Phone  9822249807  
Fax    
Email  santosh.chavan@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth (Deemed to be University)College of Ayurved and Hospital,Department of Panchakarma Katraj Pune Maharashtra India 411046 
 
Primary Sponsor  
Name  Dr Bidushi Mishra 
Address  Bharati Vidyapeeth(Deemed to be)University,Bharati Ayurved Hospital,Department Of Panchakarma OPD No 21,Dhankwadi,Katraj,Pune 
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 Bidushi Mishra   College of Ayurveda Bharati Vidyapeeth  OPD number 21 Ground floor Department of Panchakarma College of Ayurved Bharati Vidyapeeth Pune Satara Road Dhankwadi Campus
Pune
MAHARASHTRA 
9827430093

bidushi.mishra-ayurved@bvp.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE(BV(DU)COA-EC)  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: AVRUTA-VATAH/AVARANAVATA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charak Siddhi Sthan, Procedure details: -Deepan & Pachan- Deepan and Pachan will be given to patient with Takra or Hingwashtak Churna for 3-5 days twice a day before meals. -Snehan- Abhyantar Snehapan by consumption of Cow`s Ghee for 3/5/7 days till Samyak Snigdha Lakshana are seen.Patient advised to take 3days Vishram for internal consumption of Cow’s Ghee -Bahya Snehan will be done on Sneha Viram Din by application of Tila Tail will be done after Samyaka Snigdha Lakshana are seen. -Swedana- Sarvanga Bashpa Peti Swedana will be done starting from Sneha Vishram Din till Virechan Karma day. -Patient will be advised to take Ushna,Drava,Amla Rasatmak Aahara,Mansarasa,Rice etc during Snehapan and previous day to Virechan procedure. -Purvakarma will be done after kostha parikshan. -PRADHANA KARMA: -Between 8-9.30 am administration of Virechak Yog according to Mridu, Madhyam and Krura Kostha. -Patient will be observed for Virechan Vegas (Episodes of induced purgation) to be observed and recorded. -Patient will be observed for Samyak Vegas and Upavegas. -Kaphant Virechan Vega will be observed. )
(1) Medicine Name: Aragwadhadi Avaleha, Reference: Charak Kalpa Sthan, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 90(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with Hypertension.
2.Newly diagnosed patients having six month duration of stage 1 Essential Hypertension SBP(150-160mmHg)or DBP(90-100mmHg)of either sex between the age group of 18 to 60 years were include in this Research project. 
 
ExclusionCriteria 
Details  1.Patient having Stage 2 Hypertension with SBP(Greater than 180mmHg)or DBP(Greater than 110 mmHg).
2.Patient having Stage 1 Essential Hypertensionwith less than six months of durations.
3.Patients contraindicated for Virechan that are Bleeding hemorrhoids,chronic fissure in ano and irritable bowel syndrome. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in Lipid profile level.  Base Line 30th day,60th day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in signs and symptoms of Hypertension  Base Line 30th day,60th 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 2 
Date of First Enrollment (India)   01/04/2025 
Date of Study Completion (India) 17/04/2026 
Date of First Enrollment (Global)  01/04/2025 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

                      According to World Health Organization (WHO), India is going to have most of the lifestyle disorders in the near future.It is estimated that 600 million people are affected worldwide with Hypertension. Hypertension results from a variety of reasons like stress, obesity, genetic factors, over use of the salts in the diet and ageing.It is a chronic non communicable disease in which the pressure exerted by the blood on the wall of the artery is elevated.It is defined as a persistent elevation of systolic Blood Pressure above 140 mmHg and diastolic pressure above 90mmHg.In Ayurveda Charak clearly describes that vyana vayu,a component of vata dosha is said to be responsible for various kinds of movement in the body.With the help of vyana vayu,heart contracts and propels blood continuously all over body so it suggests the involvement of vyana vayu in regulation of blood pressure.In modern medicine lots of drugs are available for controlling blood pressure but they have some side effect, Hence people are looking towords ayurvedic treatment.

            Previously Hypertention is studied in various ways. From those study we can state that Virechan karma can be found impressively effective in the treatment of Hypertention. Aragwadha is the drug of choice as a Mrudu Virechak that is not only beneficial for adults but is safe even for children.It act as Madhura,Tikta,Katu                  Kashaya Rasa having Tridoshashamaka properties which helps in reducing hypertension by removing Margavarodha and daily elimination of excess morbid toxic materials from the body through Adhobhaga by the predominance of Jala and Prithvi Mahabhutas.Thereby it helps in pacifying kapha and pitta Doshas and simultaneously having its effect on Rakta and regulates the activity and movement of Vata Dosha by its anulomana action.Virechana helps to decrease the fluid volume which reduces the cardiac output,subsequently corrects the Rasa,Rakta Samvahana and helps to reduce the Hypertension.


 
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