FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071045 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 06/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study and compare the effect of drug Jatamansi choorna & life style modification in patient with Prehypertension 
Scientific Title of Study   A Comparative Study On Efficacy Of Jatamansi Choorna (Nardostachys jatamansi Dc.) And Lifestyle Modification In Aavarana Vata W.S.R. To 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  Dr Bagwan Alisha Samiulla 
Designation  PG Scholar 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, PG studies and Research Centre. 
Address  Department of Dravyaguna Speciality OPD Number 3 KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya PG studies and Research Centre

Belgaum
KARNATAKA
590003
India 
Phone  8147452646  
Fax    
Email  alisha8551@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Chougale 
Designation  Professor and HOD  
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, PG Studies and Research Centre. 
Address  Department of Dravyaguna Speciality OPD Number 3 KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964749993  
Fax    
Email  punarjeevam@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arun Chougale 
Designation  Professor and HOD  
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, PG Studies and Research Centre. 
Address  Department of Dravyaguna Speciality OPD Number 3 KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964749993  
Fax    
Email  punarjeevam@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri BM Kankanwadi Ayurveda Hospital PG studies and Research Centre Belagavi Karnataka India 590003 
 
Primary Sponsor  
Name  KLE Shri BM Kankanwadi Ayurveda Hospital PG Studies and Research Centre  
Address  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belagavi  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
KLE Shri BM Kankanwadi Ayurveda HospitalPG Studies and Research Centre  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belagavi  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bagwan Alisha Samiulla  Ayurveda Hospital  Speciality OPD no. 3 ,KAHERs Shri BM Kankanwadi Ayurveda College,PG Studies and Research Centre, Shahapur, Belagavi
Belgaum
KARNATAKA 		 8147452646

alisha8551@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects  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: Aavarana Vata, (2) ICD-10 Condition: I10||Essential (primary) hypertension, (3) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: NANATMAJAVATAVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Jatamansi moola , Reference: Bhavprakasha Nighantu, Karpuradi Varha, Shloka no. 89, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: water), Additional Information: Each Capsule will contain 500mg of Jatamansi Choorna and will be administered as 2 capsules TID
2Comparator ArmLifestyle--Dinacarya: Regular walking (5k steps), Ritucarya: -, Acara Rasayana:-, Other:-, Pathya/Apathya:yes, Pathya:Low salt diet Low calorie diet Water intake (35ml/kg) , Apathya:-
3Intervention ArmLifestyle--Dinacarya: Regular walking (5k steps), Ritucarya: -, Acara Rasayana:-, Other:-, Pathya/Apathya:yes, Pathya:Low salt diet Low calorie diet Water intake (35ml/kg) , Apathya:-
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Systolic Blood pressure range – 120-139 mmHg

2 Diastolic Blood pressure range –80-89 mmHg.
 
 
ExclusionCriteria 
Details  All Systemic disorders
1 Known case of Hypertension ( 140/90 Above)
2 Known case of Diabetes
3 Known case of Kidney Disease
4 Known case of Thyroid disorder
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Jatamansi Choorna if proven efficacious would facilitate in managing blood pressure in Prehypertension significantly.
 		 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Life style Modification is Efficacious in managing Blood pressure in Pre hypertension  3 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 4 
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="0"
Months="10"
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  

NEED FOR THE STUDY: 

Prehypertension is a condition characterized by blood pressure levels that are elevated but not yet meeting the diagnostic criteria for hypertension. 

Prehypertension means you’re at risk for developing hypertension, cardiovascular disorders, kidney disease and in long run can cause organ damage too.

 

According to Front Public Health, 27 January 2023 Sec. Public Health Policy

Volume 10 – 2022- This paper uses the Demographic and Health Survey data of

637,396 individuals from India (2019–21) and analyse the prevalence of

prehypertension and many people live with it for prolonged periods without realizing

it. According to this paper, pre-Hypertension is higher among males than females

counter parts 51.3 vs. 36.7. Strikingly, the distribution of patients is higher in

comparison to hypertension in urban areas and rural areas in India.

     Aavarana Vata is one of the pathological events of Vata Dosha in which obstruction / occlusion of movement of Vata, leads to its aggravation. Vagbhata explains the concept of Aavarana after explaining the condition vatashonita, which is an example of the concept of Aavarana itself. In vatashonita there is raktadushti, vatakopa and the Aavarana of the two, before the manifestation of the disease.

Keeping this in view Single Drug with effective dosage and cost w. r. t. the drug Jatamansi Choorna (Nardostachys jatamansi DC.) having action like Asrashodhana (blood purifier) and Vatakaphahara is considered for current study.


 
Close