| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAJAVATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. |