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CTRI Number  CTRI/2025/08/093359 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [therapeutic]  
Study Design  Single Arm Study 
Public Title of Study   Clinical study to evaluate the effect of blood letting in blood pressure 
Scientific Title of Study   Clinical study to evaluate the upashayatmaka effect of Raktamokshana in shonita dushti essential hypertension 
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 Neethusree vs 
Designation  PG Scholar 
Affiliation  Alvas ayurveda medical college and hospital 
Address  Dept of PG studies in roganidana evum vikriti vigyan Alvas ayurveda medical college and hospital,Vidyagiri,Moodubidire,
Dakshina Kannada,karnataka
Dakshina Kannada
KARNATAKA
574227
India 
Phone  06238670147  
Fax    
Email  neethusreevs97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashanth jain 
Designation  Hod and Professor 
Affiliation  Alvas ayurveda medical college and hospital 
Address  Dept of PG studies in Roganidana evum vikriti vigyan Alvas ayurveda medical college and hospital,Vidyagiri,Moodubidire,
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India 
Phone  9901327241  
Fax    
Email  drprashanthjain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prashanth jain 
Designation  Hod and Professor 
Affiliation  Alvas ayurveda medical college and hospital 
Address  Dept of PG studies in roganidana evum vikriti vigyan,Alvas ayurveda medical college and hospital,Vidyagiri,Moodubidire,
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India 
Phone  9901327241  
Fax    
Email  drprashanthjain@gmail.com  
 
Source of Monetary or Material Support  
Alvas ayurveda medical college and hospital, moodubidire,dakshina kannada,574227 
 
Primary Sponsor  
Name  Dr Neethusree vs 
Address  Dept of PG Studies in Roganidana evum vikriti vigyana,Alvas Ayurveda Medical College and Hospital,D.K district, Karnataka,574227 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Neethusree V S  Dept of PG Studies in Roganidana evum vikriti vigyana,Alvas Ayurveda Medical College and Hospital,Dakshina kannada district, Karnataka,574227 
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 Neethusree vs  Alvas ayurveda medical college and hospital  Dept of PG studies in roganidana evam vikriti vigyan,Alvas ayurveda medical college ,Vidyagiri,Moodubidire, Dakshina Kannada
Dakshina Kannada
KARNATAKA 
06238670147

neethusreevs97@gamail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE ALVAS AYURVEDA MEDICAL COLLEGE  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: RAKTAVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Ashtanga hridaya,sutrasthana.27/18-24, Procedure details: SIRAVYADHA PROCEDURE; Poorvakarma o procedure will be explained to patient in advance, & written consent will be taken. o Yavagu pana;120 ml o Abhyanga & sweda;Abhyanga with Murchitha oil to RT lower limb (posterior Tibial vein)gently followed by sthanika pata sweda for 3-5 min. Pradhana karma; o Patient is made to sit comfortably over examination table with leg hanging down. o Then the part is cleaned with surgical spirit o A torniquet is tied above the site to make sira prominent & if essential mild blow will given over the sira. o The sterile needle of 18 gauze no. will introduced into the sira. o When the needle is in situ a measuring jar kept for collection of blood. o Needle is taken out after the collected blood measures 300ml. pashchathkarma ; o After letting out blood needle is taken out & sterile cotton pad is kept & bandaged. o Patient will be advised to take rest in supine position )
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Rakta Mokshana Arha
patient of newly diagnosed with grade 1 hypertension
systolic blood pressure;140-159
diastolic blood pressure;90-99 
 
ExclusionCriteria 
Details  patient suffering from grade 2&3 hypertension .
patient suffering from secondary hypertension
patient suffering from hypertension with diabetes mellites, anemia, renal disease and other systemic disease
known case of blood coagulating disorders
Raktamokshana anarha 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
diagnosing patient of primary hypertension  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Doing the blood letting procedure & checking blood pressure  blood pressure checking on 1st day just after blood letting & follow up on 8th day & 16 th day 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   03/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

BRIEF RESUME OF INTENDED WORK:  "CLINICAL STUDY TO EVALUATE THE EFFECT OF RAKTAMOKSHANA IN SHONITADUSHTI( ESSENTIAL HYPERTENSION)"

 

NEED FOR THE STUDY

Life style disorders are major health issues found Globally. The country has been undergoing a rapid transition in health over the past several decades -a shift from infectious disease to non-communicable disease

AIM OF STUDY

 

       To evaluate therapeutic effect of raktamokshana in patient suffering from   shonithadushti/Essential Hypertension.

 

 

 

OBJECTIVES OF THE STUDY:

·       To evaluate the therapeutic effect of siravyadha in patient suffering from Shonithadushti /Essential  Hypertension

 

 HYPOTHESIS

·       H01-there is no statistical significant effect of raktamokshana on systolic hypertension.

·       H1-There is statistical significant effect of raktamokshana on systolic hypertension.

·       H02-There is no statistical significant effect of raktamokshana on diastolic hypertension.

·       H2-There is statistical significant effect of raktamokshana on diastolic hypertension.

·       H03-There is  no statistical  significant effect of Raktamokshana on Shonithadushti/   Hypertension.

·       H3-There is statistical  significant effect of Raktamokshana on Shonithadushti/ Hypertension.

 

7.METERIALS AND METHODOLOGY:

7.1 SOURCE OF DATA

LITERARY SOURCE:

Literary source of Shonithadushti, Raktamokshana ,Hypertension from all classical ayurvedic texts, modern works, internet sources and concerned articles, previous works done also will be studied and documented for intended study.

SAMPLE SOURCE:

For the present study patients of either sex will be selected  randomly without bias of social, economic, or religious status from the O.P.D and I.P.D. of Alva’s Ayurveda Medical College, and other referrals.

 

 

7.2 METHOD OF COLLECTION OF DATA:

 20  patients will be selected suffering from Shonitadushti/Essential Hypertension. A special case Proforma will be prepared with the details of causative factors, history taking, physical signs and symptoms as mentioned in our classics and allied science. Patients will be analysed and selected accordingly who fulfills the diagnostic and inclusion criteria.

 

MATERIALS USED FOR SIRAVYADHA

·       Scalp vein set number 18

·       Gauze

·       Torniquet

·       Sterile glove no.6

·       Sterile cotton

·       Cotton pad

·       Surgical spirit

·       Sterile bandage

·       Measuring jar

·       Snehana with Murchitha tila taila

·       pata sweda

 

SIRAVYADHA PROCEDURE;

 

Poorvakarma

o   procedure will be explained to patient in advance, and written consent  will be  taken.

o   Yavagu pana;120 ml

o   Abhyanga and sweda;Abhyanga with   Murchitha oil   to  RT  lower limb (posterior Tibial vein)gently followed by sthanika pata sweda for 3-5 min.

Pradhana karma;

o   Patient is made to sit comfortably over examination table with leg hanging down.

o   Then the part is cleaned with surgical spirit

o   A torniquet is tied above the site to  make sira prominent and if essential mild blow will  given over the sira.

o   The sterile needle of   18 gauze no. will  introduced into the sira.

o   When the needle is in situ a measuring jar kept for collection of blood.

o   Needle is taken out after the collected blood measures 300ml.

pashchathkarma ;

o   After letting out blood needle is taken  out  and sterile cotton pad is kept and bandaged.

o   Patient will be advised to take  rest in supine position

a) STUDY DESIGN:

It will be a Single Arm clinical  study of  20 patients suffering Shonitadushti / Essential hypertension.

b) DIAGNOSTIC CRITERIA9:

-The patients suffering from stage 1 Essential hypertension along with minimum  3 of  below symptoms will be selected for the study.

·       Shiroruk/Headache

·       Atidaurbalya/Debility

·       Krodapracurata/Anger

·       Tamodarshana/Flashes before eyes

·       Brama/giddiness

·       Klama/Easy fatigability

·       Akshiraga/redness of eye

 
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