FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064342 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 15/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Treatment in Essential Hypertension. 
Scientific Title of Study   A Comparative clinical study, to evaluate the efficacy of Haritakyadi yoga with Sarpagandha Mishrana in 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 KIRAN KUMAR BUDIHAL 
Designation  2nd Year MD Scholar (AYU) 
Affiliation  Government Ayurveda Medical College Mysuru 
Address  Department of Post Graduate Studies in Kayachikitsa, Government Ayurveda Medical College,Mysuru

Mysore
KARNATAKA
570001
India 
Phone  9606657837  
Fax    
Email  kirancb1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SANJAYKUMAR M D 
Designation  PROFFESSOR  
Affiliation  Government Ayurveda Medical College Mysuru 
Address  Department of Post Graduate Studies in Kayachikitsa, Government Ayurveda Medical College,Mysuru

Mysore
KARNATAKA
570001
India 
Phone  9986083244  
Fax    
Email  drsanjaygowda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR KIRAN KUMAR BUDIHAL 
Designation  2nd Year MD Scholar (AYU) 
Affiliation  Government Ayurveda Medical College Mysuru 
Address  Department of Post Graduate Studies in Kayachikitsa, Government Ayurveda Medical College,Mysuru

Mysore
KARNATAKA
570001
India 
Phone  9606657837  
Fax    
Email  kirancb1996@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College,Mysuru 
 
Primary Sponsor  
Name  DR KIRAN KUMAR BUDIHAL 
Address  Department of Post Graduate Studies in Kayachikitsa, Government Ayurveda Medical College,Mysuru 
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 KIRAN KUMAR BUDIHAL  Government Ayurveda Medical College and Hospital, Mysore.  Kayachikitsa OPD, Room number 10 and Inpatient wards of Government Ayurveda Medical College and Hospital, sayyaji rao road, vishweshwaraiah circle, mysore, 570001.
Mysore
KARNATAKA 
9606657837

kirancb1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Government Ayurveda Medical College, Mysuru.   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: Uchcha Raktachapa, (2) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Haritakyadi yoga, Reference: Charaka samhita, chikitsa sthana, prathama paada, first chapter, verse number 25., Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna jala), Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Sarpagandha mishrana, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshnajala), Additional Information: Sarpagandha mishrana is proprietary ayurvedic medicine which is not mentioned in any ayurvedic clssical treatises or textbooks.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects fulfilling the Diagnostic criteria, for stage 1 cases of Essential Hypertension as per the guidelines of Eighth Joint National Committee.
2.Freshly diagnosed and untreated case of Essential Hypertension.
3.Old Cases who are on Antihypertensive medications with flush out period of 7 days. 
 
ExclusionCriteria 
Details  1.Patients with Stage 2 Hypertension, SBP more than 160 and DBP more than 100 will be excluded.
2.Patients with Secondary hypertension will be excluded.
3.Patient with Malignant and Accelerated hypertension will be excluded.
4.Hypertension associated with end organ damage such as Vasculopathies, cerebrovascular damage, Heart disease, Neuropathies and other systemic illness will be excluded.
5.Patents with Uncontrolled Diabetes mellitus, RBS more than 300 mg per dl will be excluded.
6.Pregnant and lactating women will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Change in Systolic blood pressure.
2.Change in Diastolic blood pressure.
3.Change in Systolic blood /Diastolic blood pressure.
4.Change in Pulse pressure. 
31st day  
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy of Haritakyadi yoga in reducing the symptoms such as head ache, giddiness, palpitations, disturbed sleep, fatigue, chest pain.   31st day 
 
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   Phase 3 
Date of First Enrollment (India)   29/03/2024 
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="15" 
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 one of the leading causes of global burden of disease, affecting more than one billion individuals and causes an estimated 9.4 million deaths per year. It doubles the risk of cardiovascular diseases including, coronary heart disease, congestive heart failure, ischemic and hemorrhagic stroke, renal failure and peripheral arterial disease. Essential hypertension is defined as blood pressure ≥ 140/90 mm of Hg, with no secondary cause identified. It is estimated that at least one in four adults in India have Hypertension. 220 million people in India are living with hypertension, but only 12% have their blood pressure under control. In contemporary science prolonged multi-drug therapies economically burden the society and causes side effects in the patients such as anti-cholinergic, gastrointestinal, genitourinary, cardio-pulmonary, functional impairment, neuro-psychiatry and cognitive, and miscellaneous symptoms.

                        The coined term Uchcha Raktachapa is equivalent to Hypertension and is neither mentioned in Samhita nor in any Samgraha Grantha, but it is stated in our classical texts that every disease cannot be given nomenclature every time". The efforts of tracing Hypertension gave rise to different opinions. Some of them are: Raktagata Vata, Dhamani Purnata, Siragata Vata, Dhamani Pratichaya, Vyanabala Vriddhi, Avruta Vata, Ajirna - Udavarta. Sarpagandha appears to be a safe and effective treatment for hypertension in Ayurveda, when used in appropriate low doses. Adverse effects of reserpine include lethargy, sedation, psychiatric depression, hypotension, nausea, vomiting, abdominal cramping, gastric ulceration. Sarpagandha mishrana a polyherbal compound has Sarpagandha in lesser quantity and is effective in Hypertension but needs to be documented by proper Clinical studies.

                         Haritakyadi" yoga mentioned in the Rasayana prakarana of Charaka samhitha has shown significant result in Hypertension when used for shodhana purpose. It has the potential to lower the lipid peroxidation and oxidative stress through which it enhances cellular uptake and organ specific activity. The primary purpose of the study is intended to analyze the efficacy of Haritakyadi yoga for shamana purpose in the management of Hypertension and to compare it with the effectiveness of Sarpagandha mishrana in Essential Hypertension. The secondary purpose of the study is to observe the efficacy of Haritakyadi yoga in reducing the symptoms of Essential Hypertension.
 
Close