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CTRI Number  CTRI/2023/12/060606 [Registered on: 21/12/2023] Trial Registered Prospectively
Last Modified On: 21/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Marma Chikitsa In Essential Hypertension 
Scientific Title of Study   Comparative Clinical Study On Efficacy Of Marma Chikitsa And Sarpagandha Churna In The Management Of 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 Vandna Raje Singh 
Designation  MD Scholar Rachna Sharir 
Affiliation  Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 
Address  PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 462003

Bhopal
MADHYA PRADESH
462003
India 
Phone  9977946306  
Fax    
Email  vandnaphr786@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj Gupta 
Designation  Reader Department Of Rachna Sharir 
Affiliation  Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 
Address  PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 462003

Bhopal
MADHYA PRADESH
462003
India 
Phone  9425647011  
Fax    
Email  drpankaj35@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vandna Raje Singh 
Designation  MD Scholar Rachna Sharir 
Affiliation  Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 
Address  PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 462003

Bhopal
MADHYA PRADESH
462003
India 
Phone  9977946306  
Fax    
Email  vandnaphr786@gmail.com  
 
Source of Monetary or Material Support  
PG Department Of Rachna Sharir Pandit Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 462003 
 
Primary Sponsor  
Name  Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 
Address  PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh  
Type of Sponsor  Government funding agency 
 
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 Vandna Raje Singh  Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh  PG Department Of Rachna Sharir Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH 		 9977946306

vandnaphr786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Pt Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh  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: HRUDROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Marma Science And Principles Of Marma Therapy - Dr S. K. Joshi, Procedure details: Every Talhridaya Marma And Ani Marma Of Each Extremities Will Be Stimulated 15-18 Times On An Average In Single Sitting.)
(1) Medicine Name: Sarpagandha, Reference: Nighantu Adarsh, Route: Oral, Dosage Form: Capsules, Dose: 2(g), Frequency: bd, Duration: 21 Days
2Comparator ArmDrugClassical(1) Medicine Name: Sarpagandha, Reference: Nighantu Adarsh, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information:
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients Of Either Sex Between The Age Of 40 Years To 70 Years.
2.Patients Having Elevated Blood Pressure With Or Without Clinical Symptoms As Described In Ayurveda And Modern Medicine.
3.Patients Having Elevated Blood Pressure Either Systolic Or Diastolic Or Both Are Included As Mentioned
Systolic Blood Pressure 140-159 mmHg
Diastolic Blood Pressure 90-99 mmHg
4. Patients Who Are Taking Allopathy Medicine Will Be Stopped During The Study Period. 
 
ExclusionCriteria 
Details  1.Patients Having Renal Or Hepatic Disease.
2.Complicated Hypertensive Case eg, Cardiovascular Disease.
3.Pregnant Women Should Be Excluded.
4.Diabetic Patients With Uncontrolled Sugar Condition.
5.Patients Having Chronic Systemic Illness.
6.Patients Not Willing For Written Consent. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It Is Expected That At The End Of Study Scholar Will Be Able To Evaluate The Effect Of Marma Chikitsa And Sarpagandha In The Management Of Essential Hypertension.  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Marma Chikitsa Is Non Pharmaceutical Approach To Treat Essential Hypertension  21 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   29/12/2023 
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   Hypertension Is A Major Cause Of Pre Mature Death World Wide. Though A Lot Of Potent Anti Hypertensive Drugs Are Available Today But None Of Them Is Free From Adverse Effects. Thats Why Marma Chikitsa Has Been Taken .
In This Study The Assessment Has Done On The Basis Of Subjective And Objective Parameter Of Essential Hypertension. The Overall Effect Of Marma Chikitsa Is Extremely Significant.
 
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