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CTRI Number  CTRI/2025/08/093736 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of Mansyadi Kwath in the Management of Hypertension 
Scientific Title of Study   Efficacy of Ayurvedic Formulation (Mansyadi Kwath) in the Management of Hypertension (Uccha Raktachapa): A Randomised Open Clinical Trial 
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 SANJAY YADAV 
Designation  P.G. Scholar 
Affiliation  Major S.D. Singh P.G. Ayurvedic Medical College and Hospital 
Address  Room No. 36, Department of Kriya Sharira, College Block, Major S.D. Singh P.G. Ayurvedic Medical College and Hospital Bewar Road, Fatehgarh, Farrukhabad, UP, India

Farrukhabad
UTTAR PRADESH
209601
India 
Phone  9412532901  
Fax    
Email  sanjayyadav12793@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ANJANA DIXIT 
Designation  HOD and Professor 
Affiliation  Major S.D. Singh P.G. Ayurvedic Medical College and Hospital 
Address  Room No. 36, Department of Kriya Sharira, College Block, Major S.D. Singh P.G. Ayurvedic Medical College and Hospital Bewar Road, Fatehgarh, Farrukhabad, UP, India

Farrukhabad
UTTAR PRADESH
209601
India 
Phone  8840026016  
Fax    
Email  8840026016ankit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SANJAY YADAV 
Designation  P.G. Scholar 
Affiliation  Major S.D. Singh P.G. Ayurvedic Medical College and Hospital 
Address  Room No. 36, Department of Kriya Sharira, College Block, Major S.D. Singh P.G. Ayurvedic Medical College and Hospital Bewar Road, Fatehgarh, Farrukhabad, UP, India

Farrukhabad
UTTAR PRADESH
209601
India 
Phone  9412532901  
Fax    
Email  sanjayyadav12793@gmail.com  
 
Source of Monetary or Material Support  
Dr. SANJAY YADAV, Major S.D. Singh P.G. Ayurvedic Medical College and Hospital Bewar Road, Fatehgarh, Farrukhabad, UP 
 
Primary Sponsor  
Name  Dr SANJAY YADAV 
Address  Room No. 36, Department of Kriya Sharira, College Block, Major S.D. Singh P.G. Ayurvedic Medical College and Hospital Bewar Road, Fatehgarh, Farrukhabad, UP, India, 209601 
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 SANJAY YADAV  Major S.D. Singh P.G. Ayurvedic Medical College and Hospital  OPD and IPD, Kayachikitsa Department, Hospital Block, Bewar Road, Fatehgarh, Farrukhabad, UP, 209601
Farrukhabad
UTTAR PRADESH 
9412532901

sanjayyadav12793@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Major S.D. Singh P.G. Ayurvedic Medical College and Hospital  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: RAKTAJAVATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Masyadi Kashaya, Reference: Siddha Yoga Samgraha Vata Rogadhikara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Essential Hypertensive patients having systolic blood pressure less then 160 and diastolic blood pressure less than 100 mmHg. 
 
ExclusionCriteria 
Details  Hypertension with IHD, CHD, CAD, Coarctationof aorta, Renal failure, Endocrine diseases, Cerebral complications e.g. hypertensive encephalopathy, cerebral haemorrhage, convulsive seizure.
Hypertensive patient having systolic blood pressure more than 160 and diastolic more than 100 mmHg.
Pregnant lady.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Treatment with Mansyadi Kwath may result in a significant reduction in blood pressure, with an expected fall of 10–15 mmHg in mean value of systolic BP and 5–10 mmHg in mean value of diastolic BP, indicating potential clinical benefit in hypertension management.  BP will be assessed on 1st and 30th day. 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   08/09/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Background: Over one-fifth of the global adult population is affected by elevated blood pressure, while cardiovascular diseases contribute to around 17 million deaths annually, representing nearly one-third of all deaths worldwide. Ayurvedic treatments play a significant role in effectively alleviating the signs and symptoms of such diseases. Masyadi Kashaya, with its specific ingredients, acts on the root cause of the condition and helps in its management. Aims & Objective - This study aims to evaluate the therapeutic efficacy of Mansyadi Kwath in the management of Uccha Raktachapa w.s.r. to Hypertension (HTN).

Material and Methods: Randomized open clinical trial of Masyadi Kwatha was done on population size of 80, for the period of one month and assesd befor and after the treatment.  Result and Discussion: Response of the intervention has been defined in lieu of improvement in the Sign & Symptoms along with subjective and objective parameters. The trial drug Mansyadi Kwath was well tolerated having no patients force to discontinue out of drug intolerance. The Clinical assessment of results shows that, Maximum number of patients 56 (70%) got moderate improvement and only 24 (30%) of patients got mild improvement after 30 days of treatment.

Conclusion: Masyadi Kwatha shows excellent improvement in assessment parameters, supported by statistical data, Mansyadi Kwatha can be effectively used alongside standard treatment, contributing significantly to the  management and improvement of Hypertension. 
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