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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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: - | 2 | Comparator Arm | Drug | Other 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. |