Effectiveness of Unani Drugs in High Blood Pressure

Phase 2

Not yet recruiting

Conditions: Essential Hypertension (Zaght al-Dam Qawi Lazimi)

Registration Number: CTRI/2017/12/011006

Lead Sponsor: Central Research Institute of Unani Medicine

Brief Summary: Hypertension is a common lifestyle disorder with a very strong risk factor predilection for cardiovascular diseases. Several surveys in the last two decades have reported a prevalence of 6.1% to 36.35% in men and 2%-39.4% in women in urban areas, and from 3%-36% in men and 5.8%-37.2% in women in rural areas respectively .The prevalence of hypertension increases with age and it is estimated that starting from around 15% -20% in early age, it increases to 75% -80% in individuals above 70 years of age.

In conventional medicine, certain classes of antihypertensive drugs such as diuretics, calcium channel blockers, ACE inhibitors and Beta-blockers etc are in vogue with certain degree of adverse effects including hyperkalaemia, metabolic acidosis, gynaecomastia, hypotension etc with some contraindications such as COPD, gout, heart block and renal artery stenosis. Furthermore, some of these medicines are much costly. Hence, the alternative therapies should be explored for the better and safe management of hypertension.

In Unani system of medicine, hypertension has been described under the term *Imtila* and various single and compound Unani drugs have been mentioned for its management such as *Tukhm-i Kahu*, *Asrol, Parsiaoshan, Dawa-us-Shifa, Habb-e-Mudir, Sharbat-e-Buzoori*, etc..

*Tukhm-i Kahu* is one among the best *Mudir* (Diuretic) Advia. Besides of being *Mudir*, it also reduces the *Hiddat* of *Khun* leading to reduction in *Imtila*and signs and symptoms associated with hypertension.

Keeping the above facts inview, it has been planned to conduct a clinical trial entitled â€œA ClinicalStudy to Evaluate the Efficacy and Safety of *Tukhm-i Kahu* inthe Management of *Zaghá¹ al-Dam Qawi Lazimi* (EssentialHypertension)â€.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

All subjects will meet the following criteria: 1-Patients of any sex in the age group of 35 to 55 years 2-Patients having Stage-I Hypertension according to JNC-8 (Systolic BP 140-159 and Diastolic BP 90-99 mmHg) with or without the following symptoms: 3-Suda (Headache) 4-Khafaqan (Palpitation) 5-Kasal (Laziness) 6-Qalaq (Anxiety) 7-Usr al-Tanaffus (Breathlessness) 8-Nabz Mumtali (Pulsus plenus) 9-Clinically stable patients 10-Patients not taking any anti-hypertensive drugs 11-Patients willing to sign the informed consent form.

Exclusion Criteria

Patients will be excluded if they meet any of the following criteria: 1-Patient with SBP â‰¥160 mmHg and DBP â‰¥100 mmHg 2-Patients of Secondary Hypertension 3-Pregnant and Lactating women 4-Obese subjects â€“ BMI >30 5-Drug Addicts, Alcoholics 6-Patients not willing to give consent 7-Patients not willing to come for follow-up.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Systolic and Diastolic BP from baseline to last follow up	On 7th 14th 21st 28th 35th and 42nd day from baseline

Secondary Outcome Measures

Name	Time	Method
1-Improvement in Signs and Symptoms of Hypertension	2-Haematological and Biochemical Assessments for Safety

Trial Locations

Locations (1): Central Research Institute of Unani Medicine
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Central Research Institute of Unani Medicine
🇮🇳Hyderabad, ANDHRA PRADESH, India
Zareena Aquil
Principal investigator
9346672375
zarzar.aquil@gmail.com