Herbal Formulation and Amlodipine in Essential Hypertension

Not yet recruiting

• Conditions: Essential (primary) hypertension. Ayurveda Condition: Vyanbala Vaishmya,

• Registration Number: CTRI/2022/09/045143
• Lead Sponsor: GURUKUL CAMPUS UAU HARDWAR

Brief Summary

This study is randomized control group, open label trial for efficacy of Herbal Formulation (medhya vati).The study wiill be conducted at UAU Gurukul Campus Haridwar in 40 patients. The assessment will be done on the basis of Subjective and Objective parameters. The study will be conducted at OPD/IPD level of PG Department of kayachikitsa. The results will be tabulated and statistically analyzed using appropriate tests.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-09
• Study Start: 2022-02-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1)Patients willing to participate in the study.
• 2)Patients of either sex with age between 18-70 years.
• 3)Patients having Hypertension between time interval of 6 months to 1 year.
• 4)Patients suffering from stage 1 Hypertension (SBP140-159mmHg, DBP 90-99mmHg) 5)Patients suffering from Isolated Systolic Hypertension.

Exclusion Criteria

• 1)Patients not willing to participate in the study.
• 2)Patients of either sex below 18 years & above 70 years will be excluded from the study.
• 3)Patients having Hypertension for <6 months and >1 year will be excluded.
• 4)Patients of stage 2 Hypertension (SBP >160mmHg and DBP >100mmHg) 5)Patients suffering from serious comorbidities like Renal failure, Coronary Artery Disease, taking medication/drug (oral contraceptives, steroids, chronic use of NSAIDs etc…) 6)Alcoholic and/or drug abusers.
• 7)History of hypersensitivity to the trail drugs or any of its ingredients.
• 8)Pregnant /lactating woman.
• 9)Patients who have completed participation in any other clinical trail during the past 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a)Headache (Shiro ruja)	At 1st day,10th day,20th day, and | 30th day
b)Giddiness (Bhrama)	At 1st day,10th day,20th day, and | 30th day
c)Palpitations (hriddrava)	At 1st day,10th day,20th day, and | 30th day
d)Breathlessness (shwasa)	At 1st day,10th day,20th day, and | 30th day
Relief in subjective parameters like-	At 1st day,10th day,20th day, and | 30th day

Secondary Outcome Measures

Name	Time	Method
The objective assessment will be done on the basis of changes in clinical findings & laboratory parameters.	1)Urine

Trial Locations

Locations (1)

Gurukul campus UAU Haridwar; 🇮🇳 Hardwar, UTTARANCHAL, India

Gurukul campus UAU Haridwar

🇮🇳Hardwar, UTTARANCHAL, India

Gudiya

Principal investigator

7398285474

gudiyaradhika77@gmail.com