| CTRI Number |
CTRI/2020/06/025833 [Registered on: 12/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relation of raktadushti on hypertension |
|
Scientific Title of Study
|
EVALUATION OF ESSENTIAL HYPERTENSION BASED ON RAKTADUSHTI HETU AND LAKSHANA OF VIDHISHONITEEYA ADHYAYA |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr CHETAN M |
| Designation |
PROFESSOR, |
| Affiliation |
DEPARTMENT OF SAMHITA AND SIDDHANTA, 3RD FLOOR, ROOM NO 1, S D M COLLEGE OF AYURVEDA |
| Address |
Thanniruhalla
Hassan
KARNATAKA
573201
India |
| Phone |
8884849477 |
| Fax |
|
| Email |
ayurchetan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAJSHREE CHITRE |
| Designation |
PROFESSOR, |
| Affiliation |
DEPARTMENT OF SAMHITA AND SIDDHANTA, ROOM NO 3,GROUND FLOOR, PARUL INSTITUTE OF AYURVEDA |
| Address |
LIMDA
VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
7083656439 |
| Fax |
|
| Email |
rajshree.chitre26938@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr CHETAN M |
| Designation |
PROFESSOR, |
| Affiliation |
DEPARTMENT OF SAMHITA AND SIDDHANTA, ROOM NO 1, S D M COLLEGE OF AYURVEDA |
| Address |
TANNIRUHALLA
Hassan
KARNATAKA
573201
India |
| Phone |
08884849477 |
| Fax |
|
| Email |
ayurchetan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF AYURVEDA
HASSAN
KARNATAKA 573201 |
|
|
Primary Sponsor
|
| Name |
S D M COLLEGE OF AYURVEDA |
| Address |
S D M COLLEGE OF AYURVEDA
B M ROAD
HASSAN |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr CHETAN M |
S D M COLLEGE OF AYURVEDA AND HOSPITAL |
OPD No. 5, Department of Kayachikitsa
Hassan
KARNATAKA |
08884849477
ayurchetan@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IECHR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both gender and willing to give consent.
Patients who have less than one year origin.
Patients who do not have any complications raised out of hypertension.
|
|
| ExclusionCriteria |
| Details |
Patients of hypertension with any other systemic involvement.
Pregnancy induced hypertension.
Secondary hypertension.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| HYPERTENSION AND CHARACTERISTIC FEATURES MENTIONED IN VIDHISHONITEEYA ADHYAYA ARE CO RELATED |
SINGLE DAY (ONE TIME ASSESSMENT) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| MANAGEMENT OF HYPERTENSION CAN BE UNDERSTOOD BY UPAVASA, RAKTAMOKSHANA AND RAKTAPITTAHARA TRETAMENT |
2 YEARS |
|
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Target Sample Size
|
Total Sample Size="362"
Sample Size from India="362"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="620" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/06/2020 |
| Date of Study Completion (India) |
15/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="10"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
0 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Hypertension is a silent killer and the method to identify it remains to be by measuring it by regular intervals. People may have complaints like dull headaches, dizzy spells, nosebleeds and sometimes associated with chest pain, severe anxiety, vision changes shortness of breath and nose bleed.According to WHO report of Prevention and Control for Cardio vascular diseases, 2001-2002, it is estimated that 600 million people are affected world wide with Hypertension. By the year 2025, approximately 1 in 3 adults aged over 20 years - 1.56 billion people worldwide, will have hypertension.The disease named as Uchcha Raktachapa is neither denoted in Samhita nor in any Samgraha Granthas, but it is stated that every disease can not be given nomenclature every time. The term ‘hypertension’ was nominated after the invention of Sphygmomanometer but before that about its existence, one can trace the pathway on the tract of symptomatology.These efforts of tracing Hypertension gave rise to different opinions. Some of them are: Raktagata Vata, Dhamani Purnata, Siragata Vata, Dhamani Pratichaya, Vyanabala Vriddhi, Avruta Vata, Ajirna - Udavarta etc. Acharya Priyavrat Sharma has mentioned it as ‘Raktavata’. The hetu and lakshana of essential hypertension seems to be in line with the description of vidhishoniteeya adhyaya. The critical analysis may enable us to understand essential hypertension from Ayurveda perspective and enables to find suitable modalities of the treatment. Study design: cross sectional survey study •Source of Data: OPD & IPD of SDM College of Ayurveda and Hospital, Hassan •Sampling: Purposive sampling for questionnaire administration. •Sample size: 362 Selection criteria: •Diagnostic Criteria: The patients are diagnosed based on the measurement of blood pressure for 3 consecutive times with the gap of 10 minutes and will be categorized based on the American Heart Association criteria for the study. •INCLUSION CRITERIA •Patients of both gender and willing to give consent. •Patients who have less than one year origin. •Patients above the age group of 30 to 70 years. Patients who do not have any complications raised out of hypertension. •EXCLUSION CRITERIA •Patients of hypertension with any other systemic involvement. •Pregnancy induced hypertension. •Secondary hypertension. Survey study 1 Pilot Study •Pilot study will be conducted for 50 patients who are diagnosed based on AHA criteria with no less than 1 year and assessed for raktadushti hetu and raktadushti lakshana. The generated questions will be checked for internal consistency and reliability by applying chronbach’s alpha. The questions with the readings of chronbach’s alpha more than 0.6 will be considered for the study. Preparation of questionnaire •Questionnaire will be prepared with following domains •Domain 1 : consists of questions related to raktadushti hetu as mentioned in vidhishoniteeya adhyaya and causative factors of essential hypertension as per contemporary science. Domain 2 : consists of questions related to raktadushti Lakshana as mentioned in vidhishoniteeya adhyaya and signs and symptoms of essential hypertension as per contemporary science. •The data obtained will be analysed for drawing conclusions.
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