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CTRI Number  CTRI/2025/08/093018 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 12/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of coriander seed juice in managing blood pressure as an extra therapy along with on going current medicines  
Scientific Title of Study   Randomized Controlled Trial of Dhanyaka hima as an Add-on Therapy in Vyanbala Vaisamya with special to Essential hypertension 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neelam Gautam 
Designation  BAMS P G Scholar 
Affiliation  Goverment Ayurved College  
Address  OPD no 6 Swastharakshan Department, Government Ayurved college and Hospital Sakkardhara Chowk Raje Raghuji Nagar Nagpur-440024 Maharashtra, India Sakkardhara Chowk Raje Raghuji nagar

Nagpur
MAHARASHTRA
440024
India 
Phone  9340489958  
Fax    
Email  neegautam1003@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sumeeta Jain 
Designation  Professor  
Affiliation  Government Ayurved College 
Address  OPD no 6 Swastharakshan Department Government Ayurved college and Hospital Sakkardhara Chowk Raje Raghuji Nagar Nagpur-440024 Maharashtra, India Sakkardhara Chowk Raje Raghuji nagar

Nagpur
MAHARASHTRA
440024
India 
Phone  9373111200  
Fax    
Email  sumeetasjain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Neelam Gautam 
Designation  B A M S P G Scholar 
Affiliation  Government Ayurved College 
Address  OPD no 6 Swastharakshan Department Government Ayurved college and Hospital Sakkardhara ChowkRaje Raghuji Nagar Nagpur 440024 Maharashtra India Sakkardhara Chowk Raje Raghuji nagar

Nagpur
MAHARASHTRA
440024
India 
Phone  9340489958  
Fax    
Email  neegautam1003@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College and Hospital Nagpur Maharastra 440024 
 
Primary Sponsor  
Name  Neelam Gautam 
Address  Government Ayurved college and Hospital, Sakkardhara Chowk Nagpur Maharastra 440024 
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 Neelam Gautam  Government Ayurved College Nagpur  OPD no.6 Swastharakshan Department Government Ayurved college and Hospital Sakkardhara ChowkRaje Raghuji Nagar Nagpur-440024 Maharashtra India Sakkardhara Chowk Raje Raghuji nagar OPD no.6 Swastharakshan Department Government Ayurved college and Hospital, Sakkardhara ChowkRaje Raghuji Nagar Nagpur-440024 Maharashtra India Sakkardhara Chowk Raje Raghuji nagar
Nagpur
MAHARASHTRA 
09340489958

neegautam1003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  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: VYANAVATAKOPAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Dhanyaka hima, Reference: Shadangdhar samhita, Route: Oral, Dosage Form: Sheeta/ Hima, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age Group 25 60 years.
2. Irrespective of sex education religion and socio-economic status
3. Patients having BP 130by80 mm Hg to 160by100 mm Hg acc to IHA Guidelines
.
4.Patients who are taking anti hypertensive medication 
 
ExclusionCriteria 
Details  1. Patients having systemic serious complications of CVS Renal system DM-type
2,Hyperlipidemia Myocardial InfarctionIschemic Heart Disease
2 Patients having abnormal ECG Values
3. Malignancy and pregnant women
4. If Patient is taking antihypertensive medication 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Dhanyak Hima as an Add-on Therapy in Essential
Hypertension.
 
1 Year
 
 
Secondary Outcome  
Outcome  TimePoints 

1) To prepare Dhanyak hima

2) to study the literature about hypertension according to Ayurveda & Modern
Sciences.

3) To study the literature of Dhanyaka in Modern Science and Ayurveda  
1 Year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   23/08/2025 
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="5" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  
Title  Randomized Controlled Trial On Dhanyaka hima as an Add-on Therapy in Vyanbala Vaisamya with special reference to Essential hypertension.
Aim
To study the effect of Dhanyaka Hima as an Add-on Therapy in Essential Hypertension
. Primary Objectives:- To study the effect of Dhanyak Hima as an Add-on Therapy in Essential Hypertension.
 Secondary Objectives:- 1) To prepare Dhanyak hima 
 2) to study the literature about hypertension according to Ayurveda & Modern Sciences.
 3) To study the literature of Dhanyaka in Modern Science and Ayurved
 Study design: A open label, parallel superiority Randomized Controlled Trial Screening of the subjects from population will be done on the basis of Inclusive criteria and exclusive criteria. 
 They will be divided into two groups randomly by computerised random sampling method after taking consent. 
 Group A ( Trial ) 50 individuals will be given Dhanyaka Hima along with anti hypertensive medication for 60 days
 Group B (Control) 50 individuals will be only given anti hypertensive medication for 60 days 
 Then assessment will be done by objective parameters before and after study and subjective parameters 
OnD-0, D-15,D-30,D-45 and D- 60 Statistical analysis with appropriate test and interpretation will be done
. Observation and Result Discussion Conclusion Duration of Treatment: 60 days Ethical Clearance: Clearance from Institutional Ethics Committee. 7.2
 Study setting (location): 7.3 Duration of Study: The study will be conducted in our hospital and its periphery. 
 18 months after approval of synopsis 10 11 7.4 Type of study: 7.5 Sample Size: 7.6 Sampling Method:
 A open label, parallel superiority Randomized Controlled Trial Study population:
 On the basis of clinical examination and history, Total individuals will be selected according to their eligibility criteria.
 Group A- 50 Individuals will be given Dhanyak Hima along with anti-hypertensive medication daily 
 Group B- 50 Individuals will be given only anti hypertensive medication daily
Inclusion criteria: 1. Age Group – 25- 60 years. 2. Irrespective of sex, education, religion and socio-economic status. 3. Patients having BP 130/80 mm Hg to 160/100 mm Hg [acc to IHA Guidelines] . 4.Patients who are taking anti hypertensive medication Exclusion criteria: 1. Patients having systemic serious complications of CVS, Renal system DM-type 2,Hyperlipidemia,Myocardial Infarction,Ischemic Heart Disease 2 Patients having abnormal ECG Values 3. Malignancy and pregnant women 4. If Patient is taking anti-hypertensive medication Withdrawal criteria: • If the selected patient who will not follow treatment protocol and instruction properly,will be conducted as dropout from study • Subject who unable to give follow up. 
 
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