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CTRI Number  CTRI/2021/04/033053 [Registered on: 23/04/2021] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of Essential Hypertension With Ayurvedic Herbal Medicine. 
Scientific Title of Study   "ASSESSMENT OF EFFICACY OF VIRECHANOTTARA KSHEERAKALYANAKA GHRITA AND JATAMAMSI CHURNA IN THE MANAGEMENTOF ESSENTIALHYPERTENSIONWITH SPECIAL REFERENCE TO UCHCHA RAKTACHAPA.” –A COMPARATIVE STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yadav Pooja Shivshankar 
Designation  P.g scholar 
Affiliation  Taranath Government Ayurvedic Medical College And Hospital 
Address  Sabhajeet Singh chawl,Hanuman Nagar Kandivali East Mumbai
Taranath government ayurvedic medical college and hospital,Dept.of p.g studies in kaya chikitsa,room no.3, Dr Rajkumar Rao road bellary
Bellary
KARNATAKA
583101
India 
Phone  9916066068  
Fax  08392-260273  
Email  yadav292pooja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrMadhava Diggavi 
Designation  Proff. & H.O.D Dept.of p.g studies in kayachikitsa 
Affiliation  Taranath Government Ayurvedic Medical College And Hospital 
Address  Dept of p.g studies in kayachikitsa. Taranath government ayurvedic medical college and hospital,ballari

Bellary
KARNATAKA
583101
India 
Phone  9844094290  
Fax  08392-260273  
Email  drmvdbly@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrMadhava Diggavi 
Designation  Proff. & H.O.D Dept.of p.g studies in kayachikitsa 
Affiliation  Taranath Government Ayurvedic Medical College And Hospital 
Address  Dept of p.g studies in kayachikitsa. Taranath government ayurvedic medical college and hospital,ballari

Bellary
KARNATAKA
583101
India 
Phone  9844094290  
Fax  08392-260273  
Email  drmvdbly@gmail.com  
 
Source of Monetary or Material Support  
Taranath government ayurvedic medical college and hospital ballari 
 
Primary Sponsor  
Name  Dept Of pg studies in kayachikitsa Taranath government ayurvedic medical college and hospital 
Address  Taranath government ayurvedic medical college and hospital,Dept of p.g studies in kayachikitsa room no 3,ballari 583101 
Type of Sponsor  Government medical college 
 
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 Yadav Pooja Shivshankar  Taranath government ayurvedic medical college and hospital ballari  Department of pg studies in kayachikitsa room no 3 taranath government ayurvedic medical college and hospital ballari
Bellary
KARNATAKA 		 09916066068

yadav292pooja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC TGAMC Ballari  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: Uchcha raktachapa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Jatamamsi churna 500mg BD   Deepana and Pachana with Panchakola Choorna 3gm TID for Until the Samyaka dipana pachana lakshanas are observed Virechana scheduleShodananga Snehapana Sneha Dravya Murchita tila taila TestDose 30ml Fixed dose scheduleas per patient 75ml 75ml and 75ml Duration untilsamyaka snigdha lakshana is observed Vishrama Kalaabhyanga with Murchita tila taila sarvanga mridu bhaspa shwedafor three days Virechan Abhayamodaka Vati 2 tab With coldwater Samsarjana krama as pershuddi lakshana Total numberof Subjects 20 Duration of study60 days Formulation Jatamamsi churna Mode of administrationOral Dosage 500mg cap 1cap BD Anupana Ushnajala Followup Every 15 days after first visitand after completion ofintervention 15 days 
Intervention  Ksheerkalyanaka Ghrita 6gm BD before food for 45 days.  Deepana and Pachana with Panchakola Choorna 3gm TID Until the Samyaka dipana pachana lakshanas are observed Virechana scheduleShodananga Snehapana Sneha Dravya Murchita tila taila TestDose 30ml Fixed dose scheduleas per patient 75ml 75ml and 75ml Duration untilsamyaka snigdha lakshana is observed Vishrama Kalaabhyanga with Murchita tila taila sarvanga mridu bhaspa shwedafor three days Virechan Abhayamodaka Vati 2 tab With coldwater Samsarjana krama as pershuddi lakshana Total numberof Subjects 20 Duration of study60 days Formulation Ksheerakalyanaka ghrita Mode of administrationOral Dosage 6gm BD Anupana Ushnajala Followup Every 15 days after first visitand after completion ofintervention 15 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of Essential Hypertension / Stage I Hypertension.
Patients between the age group of 30-65 years.
Patients suffering from Stage I Hypertension. 
 
ExclusionCriteria 
Details  CCF
EF<30%
Multiorgan failure
Pleural effusion
Acute IHD/M.I
C.R.F with Sr. Creatinine>8 mg/dl SEPSIS 
 
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 
Maintenance of Blood pressure to normal level  6weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Correction of high blood pressure
Improvement in cardiac markers 		 8 week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/04/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="5" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Hypertension is a syndrome with elevated blood pressure and modifiable risk factor for cardiovascular, cerebrovascular,renovascular disorders, prevalence increasing at an alarming rate, about 20-24% incidence rate. No direct reference of hypertension is found in ayurvedic texts but the symptoms of diseases like shirahshoola tridoshaja shiroroga unmad vatarakta Raktagata vata Dhamani Pratichaya shleshmavruta vata medoroga show the symptoms of essential hypertension. With a null hypothesis to know the effect of ksheerakalyanaka ghrita which will reduce atherosclerosis peripheral resistance shothahara unmadahara kaphamedahara action is selected. Jatamamsi is a potent aromatic herb known for its tranquilizing anti-convulsive and calming effect. Jatamamsi is Tridoshashamaka shothahara apasmaranashaka murchhahara nidrajanaka and shamaka. So classical drug as well as the single drug show unmadahara effect. Untreated, uncontrolled essential hypertension also mimics unmad. Therefore ksheerakalyanaka ghrita and jatamamsi churna have similar clinical pharmacology acting on Doshanulomana avaranaghna dhatusamyakara and manaprasadana. Hence present study entitled "Assessment of efficacy of Virechanottara ksheerakalyanaka ghrita and jatamamsi churna in the management of essential hypertension with special reference to uchcha raktachapa-A comparative study" is taken. 
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