| CTRI Number |
CTRI/2021/07/035098 [Registered on: 23/07/2021] Trial Registered Prospectively |
| Last Modified On: |
20/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role Ayurveda in Hypertention |
|
Scientific Title of Study
|
Efficacy of Nityavirechana in Management Of Essential Hypertension - An Open Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pratibha |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
8970860890 |
| Fax |
|
| Email |
pratibha051995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashekhar Sanapeti |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajashekhar Sanapeti |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Near Nathpai Circle Shahapur Belagavi - 590003 |
| 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 |
| Dr Pratibha |
KLE Ayurveda Hospital |
OPD NO 04 and IPD of KLE Ayurveda Hospital Shahapur Belagavi 590003
Belgaum
KARNATAKA |
8970860890
pratibha051995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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: ucca rakta chapa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NITYAVIRECHANA |
Manibradra guda 1st three days 12 gm next 15 days 6 grams orally total 18 days with warm water |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of hypertension
Patients with known case of hypertension
Patients suffering from Stage1 hypertension
Patients fit for virechana |
|
| ExclusionCriteria |
| Details |
Patients suffering from secondary hypertension
Patients with Stage 2 and Stage 3 hypertension
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nitya Virechana is efficient in management of Hypertension. And able to reduce the systolic BP below 130mmHg |
0th day 1st 2nd & 3rd day 4th day 19th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
01/12/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 considered as one of the most common disorder globally mainly due to changing lifestyle, obesity ,smoking,alcohol,dietary changes, etc. The prevalence rate of Hypertension in India is 52.3% also previous studies indicate that 40.3% for the age group of 30-74 years with Stage-1 hypertension have a 10 year risk of developing cardiovascular disease.1 Long term hypertension is a major risk for coronary heart disease ,stroke,heart failure ,atrial fibrillations, peripheral arterial disease ,vision loss, chronic kidney disease , dementia,organ malfunction.2 According to contemporary medicine the existing treatment modalities for hypertension viz ACE inhibitors, β -blockers have following side effects- dizziness,headache, hypotension, hypoglycemia, bradycardia, debility, impotence,GERD, drowsiness, constipation.3 In Ayurveda ,hypertension can be considered one among shonita dushti, virechana is considered pradhana chikitsa for shonita vikara which can result in sharira shodhana and hridya/ sroto-vishudhi . Hence an attempt is made to evaluate the role of virechana karma in hypertension |