Ayurvedic Treatment in Essential Hypertension.

Phase 3

Not yet recruiting

Conditions: Essential (primary) hypertension. Ayurveda Condition: Uchcha Raktachapa, (2) ICD-10 Condition: I10||Essential (primary) hypertension,

Registration Number: CTRI/2024/03/064342

Lead Sponsor: DR KIRAN KUMAR BUDIHAL

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 â‰¥ 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in Systolic blood pressure.	31st day
2.Change in Diastolic blood pressure.	31st day
3.Change in Systolic blood /Diastolic blood pressure.	31st day
4.Change in Pulse pressure.	31st day

Secondary Outcome Measures

Name	Time	Method
Efficacy of Haritakyadi yoga in reducing the symptoms such as head ache, giddiness, palpitations, disturbed sleep, fatigue, chest pain.	31st day

Trial Locations

Locations (1): Government Ayurveda Medical College and Hospital, Mysore.
🇮🇳
Mysore, KARNATAKA, India
Government Ayurveda Medical College and Hospital, Mysore.
🇮🇳Mysore, KARNATAKA, India
Dr KIRAN KUMAR BUDIHAL
Principal investigator
9606657837
kirancb1996@gmail.com