| 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 |
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Public Title of Study
|
Study on the role of stimulation of talahridaya marma in left hand on blood pressure |
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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 |
|
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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] |
|
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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 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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurveda Medical College Bengaluru |
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. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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. )
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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
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in blood pressure |
Same day after 10 minutes |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of talahridaya marma for any discomforts after stimulation |
Same day after 10 minutes |
|
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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