| CTRI Number |
CTRI/2021/07/035014 [Registered on: 20/07/2021] Trial Registered Prospectively |
| Last Modified On: |
04/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic treatment of Hypertension |
|
Scientific Title of Study
|
An Etiopathological Study Of Raktagata Vata w.s.r. To Hypertension And Their Upshayatamaka Parikshana With Sudhesh Vati |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudeep Singh gangwar |
| Designation |
MD Scholar |
| Affiliation |
Government ayurvedic PG college and hospital chuakaghat varanasi |
| Address |
Roga nidana department of Government ayurvedic college and hospital chaukaghat varanasi UP
Roga nidana department of Government ayurvedic college and hospital chaukaghat varanasi UP
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
7017064490 |
| Fax |
|
| Email |
ssg16490@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avadhesh Kumar |
| Designation |
Reader and HOD |
| Affiliation |
Government ayurvedic PG college and hospital chaukaghat Varanasi |
| Address |
Roga nidana department of Government ayurvedic college and hospital chaukaghat Varanasi UP
Roga nidana department of Government ayurvedic college and hospital chaukaghat Varanasi UP
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8115543538 |
| Fax |
|
| Email |
dravadheshsaroj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avadhesh Kumar |
| Designation |
Reader and HOD |
| Affiliation |
Government ayurvedic PG college and hospital chaukaghat Varanasi |
| Address |
Roga nidana department of Government ayurvedic college and hospital chaukaghat Varanasi UP
Roga nidana department of Government ayurvedic college and hospital chaukaghat Varanasi UP
UTTAR PRADESH
221002
India |
| Phone |
8115543538 |
| Fax |
|
| Email |
dravadheshsaroj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government PG Ayurveda college and hospital Varanasi |
|
|
Primary Sponsor
|
| Name |
Government ayurvedic PG college and hospital Varanasi |
| Address |
Government ayurvedic PG college and hospital chaukaghat Varanasi UP
221002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sudeep Singh Gangwar |
Government ayurvedic PG college and hospital |
Dhupchandi Jaitpura
Varanasi
221002
Varanasi
UTTAR PRADESH |
7017064490
ssg16490@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: Raktagata Vata, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Sudhesh Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from Hypertension |
|
| ExclusionCriteria |
| Details |
Patient suffering from Malignancies and Chronic systemic diseases like Uncontrolled DM Severe Renal disease Severe Heart disease Endocrine diseases
Hypertension during Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Sign and Symptoms of Raktagata Vata |
One month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve Quality of life of Person |
After Six weeks from day of enrollment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/07/2021 |
| Date of Study Completion (India) |
30/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Under this clinical study 60 patient of Raktagata Vata were treated with Sudhesh Vati. This medicine have Raktagatavata shamak , Medhya, Anidra nashak, mutral and hridyarogahara effect and cure Raktagata vata and other associated symptoms. The period of trial was one month and seven days fallow up. Patients selected from OPD and IPD and were diagnosed on the basis of Sign and Symptoms and by measuring Blood Pressure. After therapy, the change in SBP was observed in 59.52% patients and in DBP was 49.39% patients. This drug showed addictive effect in the patients who were taking antihypertensive medications |