| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: VYANAVATAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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. |