FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077734 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of Talahridaya Marma chikitsa and sarpaghandha ghan vati in the management of Prehypertension  
Scientific Title of Study   An Anatomical study of Talahridaya Marma and Role of Talahridaya Marma Chikitsa and Sarpaghandha Ghan Vati in the Management of Prehypertension :A Randomised Controlled Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chanchal Yogi 
Designation  Md Scholar 
Affiliation  National institute of ayurveda, jaipur 
Address  Chanchal Yogi C/O Himanshu Yogi, 51, Mangal Vihar, Yamuna Path, Near Pratap Circle, Gokulpura, Kalwar Road, Jaipur (Rajasthan)
Chanchal Yogi C/O Himanshu Yogi, 51, Mangal Vihar, Yamuna Path, Near Pratap Circle, Gokulpura, Kalwar Road, Jaipur (Rajasthan)
Jaipur
RAJASTHAN
302012
India 
Phone  07413957961  
Fax    
Email  chanchalyogi1412@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunil Kumar Yadav  
Designation  Professor 
Affiliation  National Institute of ayurveda,Jaipur 
Address  Dept.of Rachana Sharir National Institute of Ayurveda,Madhav Vilas Amber Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9413181445  
Fax    
Email  drskyadav4@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sunil Kumar Yadav  
Designation  Professor 
Affiliation  National Institute of ayurveda,Jaipur 
Address  Dept.of Rachana Sharir National Institute of Ayurveda,Madhav Vilas Amber Road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9413181445  
Fax    
Email  drskyadav4@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda madhav vilas palace amer road 302002,Jaipur (rajasthan) india 
 
Primary Sponsor  
Name  National Institute of Ayurveda ,Jaipur 
Address  National Institute of Ayurveda,jaipur 
Type of Sponsor  Government medical college 
 
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 Chanchal yogi  Opd no.3 NATIONAL INSTITUTE OF AYURVEDA ,JAIPUR  National Institute of Ayurveda Jorawar singh gate Amer road Madhav vilas palace 302002 Jaipur Rajasthan
Jaipur
RAJASTHAN 
7413957961

chanchalyogi1412@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA  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: DHAMANIPRATICAYAH (KEVALA-KAPHA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: sarpagandha ghan vati, Reference: ayu.sar sangrha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
2Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: CCRAS BOOK OF MARMA CHIKITSA, Procedure details: Three times stimulations in one sitting(Two sitting in a day) Technique- by pulp of 3 finger side to side movement Marma to be stimulate :Talahridaya Marma Chikitisa protocol:15 days)
(1) Medicine Name: Sarpaghandha Ghan Vati, Reference: Ayurveda sara sanghra, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 125(mg), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient lying within the age group of 21-50 years
Patient is currently not taking any drugs for hypertension
Patient will come under the prehypertension range 120-139 mm of Hg systolic BP to 80-89mm of Hg diastolic BP 
 
ExclusionCriteria 
Details  Patient who are suffering from acute systemic disease
Pregant lady,lactating mothers and females who have recent history of abortion
Patient coming under the range of grade 1 and grade 2 hypertension 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in JNC criteria  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the patient condition  30 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   16/12/2024 
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 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  

Need of the Study

Hypertension is a prevalent disorder that affects a significant proportion of the global population. Despite the existence of various antihypertensive treatments, the prevalence of hypertension is on the rise not only among the elderly population but also among young adults. Currently the modern medicinal treatment involves various drugs for the treatment of hypertension and a longer intake of such medicines comes with its own side effects on the human body. Considering these reasons, Marma chikitsa could be a better alternative to the current practise of treating hypertension. Clinicians who practise Marma chikitsa have observed a normalising effect on blood pressure, through this non-invasive method of treatment, hypertension and other diseases associated with it could be treated in a holistic manner [5]. Although the lack of clinical data on the effectiveness of this chikitsa has resulted in its limited application across various diseases, thus leaving its potential largely unexplored [3].

In Marma chikitsa a very light stimulation of Marma points on the body is done. Marma points when gently pressed on the skin can stimulate a chain of flow of Prana. Marma chikitsa can make the treatment easy without any medicinal use. Therefore, an attempt is made through this study to treat and manage prehypertension.

Aim:  

·       Compare the efficacy of Talahridaya Marma chikitsa with Sarpagandh Ghan Vati in the management of prehypertension.

Objectives:

1.     An anatomical study of Talhridaya Marma.

2.     To evaluate the effectiveness of Talahridaya Marma chikitsa in the management of prehypertension.

Statement of Hypothesis

Null Hypothesis (Ho):

•        There is no difference in the effect of Talahridaya Marma Chikitsa and Sarpaghandha ghan vati in the management of prehypertension.

 

Alternative Hypothesis (Ha):

•        Talahridaya Marma Chikitsa is more beneficial than Sarpaghandha ghan vati in the management of prehypertension.

Outcome:

Change in JNC criteria

Materials and Methods

Step 01: Conceptual Study

·       Detail study of Talahridaya Marma as per Ayurveda classic and through cadaveric study

·       Detail study of hypertension as per modern literature

Step 02: Interventional study

An interventional open randomize trial involving 30+30 volunteer with the age group of 21-50 years of either gender will be taken for the study. For clinical study, patient attending OPD of Rachana Sharir in National Institute of Ayurveda (NIA) Arogyashala, SSBH and Satellite Hospital, Jaipur will be selected randomly with the symptoms of prehypertension.

Patients Selection Criteria

Inclusion Criteria:

·       Patients lying within the age group of 21-50 years.

·       Patient is currently not taking any drugs for hypertension.

·       Patient will come under the prehypertension range = 120-139 mm of Hg systolic BP to 80- 89 mm of Hg Diastolic BP.

Exclusion Criteria:

·       Patient who are suffering from acute systemic disease

·       Pregnant lady, lactating mothers and females who have recent history of abortion.

·       Patient coming under the range of grade 1 and grade 2 hypertension.

Withdrawal Criteria (Any of the following):

·       Patient himself /herself wants to withdraw from the trail.

·       Serious adverse reaction where continuation of the study pauses a serious risk to the participant.

·       Participant’s condition deteriorates during the course in the opinion of the clinician i.e., further continuation of the study is likely to be detrimental to health of participant.

·       Development of clinical condition leads to violation of inclusion /exclusion criteria.

Methodology

1.     Study Design: Open labeled randomized controlled clinical trial

·       Study Type: Randomized controlled clinical trail

·       Purpose: Treatment of pre-hypertension

·       Masking: Open label

·       Number of Groups: 02 groups

2.     Sampling Method: Random Sampling

·       Randomization:  Computer generated random number table

·       Sample Size: 60 (each group assigned 30 patients)

3.     Research Design: Interventional study

·       Study Duration: 30 Days

·       Follow up: 15 days

4.     Reference: Ayurveda.Sar Sanghra and Siddha Yoga Sanghra

5.     Ingredients of Drug: Sarpaghandha Ghan Vati

 

Drug name

Botanical name

Part

01.

Sarpagandha

Rauvolfia serpentine

Root

02.

Khurasani yavani

Trachyspermum ammi

Seed

03.

Jatamansi

Nardostachys jatamansi

Rhizome

04.

Bhanga

Cannabis sativa

Leaf

05.

Pippalimoola

Piper longum

Root

 

Groups

The selected patient will be randomly divided into two group viz group A and group B on the basis of computer-generated random number chart. There will be equal number i.e., 30 patients in each group.

Group A: 30 Patients

  • Patients will be given Marma chikitsa for a period of 30 days.
  • Chikitsa period: maximum 30 days
  • Follow up: 15 days
  • Chikitsa protocol: Three times stimulations in one sitting (Two sitting in a day)
  • Technique - by Pulp of 3 finger side to side movement.
  • Marma to be stimulate: Talahridaya Marma

 

Group B: 30 Patients

  • Patients will be given Sarpaghandha Ghan Vati.
  • Dose- 125 mg BD
  • Time- After food

Assessment Criteria

·       JNC Criteria

 

BP Classification

SBP (mmHg)

DBP (mmHg

Normal

≈120

≈80

Prehypertension

120-139

80-89

Stage 01 Hypertension

140-159

90-99

Stage 02 Hypertension

> 160

>100

Table 1: Classification of Hypertension

 

·       Lipid Profile

Statistical Analysis

1.     Paired t-test

2.     Unpaired t-test (between comparison)

 
Close