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CTRI Number  CTRI/2024/07/071257 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 16/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Marma stimulation]  
Study Design  Single Arm Study 
Public Title of Study   Study on the role of stimulation of talahridaya marma in left hand on blood pressure  
Scientific Title of Study   Critical study on the role of stimulation of talahridaya marma in vama urdhwa shakha on blood pressure with special reference to its regional anatomy  
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 Ansa P Antony  
Designation  Post graduate Scholar  
Affiliation  Government Ayurveda Medical College, Bengaluru  
Address  Department of Rachana Shareera, Government Ayurveda Medical College,Bengaluru, Karnataka, 560009

Bangalore
KARNATAKA
560009
India 
Phone  9497794919  
Fax    
Email  ansapantony@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suryakanth V Ghule  
Designation  Associate Professor  
Affiliation  Government Ayurveda Medical College Bengaluru  
Address  Department of Rachana Shareera, Government Ayurveda Medical College, Bengaluru, Karnataka

Bangalore
KARNATAKA
560009
India 
Phone  9448258382  
Fax    
Email  drsuryakanthghule@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suryakanth V Ghule  
Designation  Associate Professor  
Affiliation  Government Ayurveda Medical College Bengaluru  
Address  Department of Rachana Shareera, Government Ayurveda Medical College, Bengaluru, Karnataka

Bangalore
KARNATAKA
560009
India 
Phone  9448258382  
Fax    
Email  drsuryakanthghule@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College, Bengaluru, Karnataka, India, 560009 
 
Primary Sponsor  
Name  Dr Ansa P Antony  
Address  Department of Rachana Shareera, Government Ayurveda Medical College, Bengaluru, Karnataka, India,560009 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Ansa P Antony   Government Ayurveda Medical College Bengaluru   Out patient department Government Ayurveda Medical College Bengaluru Karnataka, India, 560009
Bangalore
KARNATAKA 
9497794919

ansapantony@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Ayurveda Medical College Bengaluru   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: RAKTAVRUTAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Marma stimulation (Procedure Reference: Gautam AS, Verma P, Kumar Pathak A. Blood pressure normalizing effect of Talahridaya marma therapy: A case report. J Ayurveda Integr Med. 2021 Jul-Sep;12(3):553-555. Doi: 10.1016/j.jaim.2021.05.014. Epub 2021 Jul 15. PMID: 34275703; PMCID: PMC8377184., Procedure details: Investigator will give stimulation to talahridaya marma by applying little pressure with thumb in coherence with breath of the patient for 12-15 times per minute. This will be continued for 3 minutes. Measurements of blood pressure will be recorded before and after the procedure. )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients with blood pressure - systolic BP 130-139 mmHg and diastolic BP 80-89 mmHg
2)Patients of either sex aged between 18 to 60 years.

 
 
ExclusionCriteria 
Details  1)Individuals with any deformity in left upper limb.
2)Pregnant and lactating women.
3)Known hypertensive cases who are on medication.
4)Patient with congenital heart disorders
5)Patient with chronic medical disorders.
6)Patient with any injury to left hand, especially on point of talahridaya marma

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in blood pressure   Same day after 10 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of talahridaya marma for any discomforts after stimulation   Same day after 10 minutes  
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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   Phase 2 
Date of First Enrollment (India)   01/08/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Marma shareera is an important concept described in Ayurveda. It is a subject of interest because of its applied aspect. References of marma can be traced way back in vedas to present modern literature.
Marma is the seat of prana and is constituted by confluence of mamsa, sira, snayu, asthi and sandhi .They are known as vital points because any injury to these points are fatal .According to Ayurveda 107 Marmas are present in the body. Acharya charaka mentioned in detail about trimarmas ie; hridaya, shiras and vasthi.
Talahridayamarma is one among shakha marma , seen as one in each limb thus total number is 4  .Location is at the center of padatala (sole)or hastatala(palm),in line with madhyama anguli( middle finger or middle toe) .It is a type of mamsa marma with size of half anguli . Talahridayamarma comes under the group of kalantarapranahara marma  (delayed death). Any injury to this point causes death due to pain . While enumerating parts of body of kaliyuga person, kasyapa samhita mentioned that there are 5 hridaya ; One is hridaya which is situated in uras , remaining 4 are talahridayamarma which are situated in padatala or hastatala. This emphasizes the importance of this marma.
Blood pressure is the hydrostatic pressure exerted by blood on walls of a blood vessel .The main factors affecting blood pressure are cardiac output, blood volume, and vascular resistance. Several interconnected negative feedback systems control blood pressure by adjusting heart rate, stroke volume, systemic vascular resistance, and blood volume. Cardiovascular center which regulate heart rate and stroke volume is located in the medulla oblongata . It receives input both from higher brain regions and from sensory receptors. Blood pressure is usually measured in the brachial artery using sphygmomanometer. Normal blood pressure of an adult is less than 120 mmHg systolic and less than 80 mm Hg diastolic. Persistent elevation of blood pressure is referred to as hypertension and it is a major reason of premature death worldwide.
Marma therapy is more acceptable among society as it is safe, cost effective and non-invasive. In susrutha samhitha, for treatment of diseases of internal organs, certain points have mentioned for siravyadha. Marma therapy has been developed taking these references into account  . Clinicians who are practicing marma therapy observed that stimulation of Talahridaya marma has an effect on cardiovascular system especially on blood pressure .This can be utilized to control blood pressure. But clinical data supporting this statement is very few. Hence this study is an attempt to find the change in blood pressure by stimulation of Talahridaya marma in urdhwashakha and to critically explore the anatomical aspect of Talahridaya marma in urdhwashakha .

 
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