"The Role of Amla as a Natural Intervention for Pre-Hypertensive Individuals"

EFFICACY AND SAFETY OF AMALAKI (PHYLLANTHUS EMBLICA) IN PRE- HYPERTENSION - A DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106690

Enrollment

100

Registered

2026-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosed cases of Pre-hypertension as per 7th report of JNC (121-139 mm of Hg SBP and or 81-89 mm of Hg DBP) 2.Individuals currently not taking any antihypertensive medications 3.Willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients who have history of Acute Coronary Syndrome, Myocardial Infarction, congestive cardiac failure, Stroke or Cardiac Arrhythmia in the last six months. 2.Known case of Essential Hypertension/ Secondary hypertension 3.Patients with BMI more than or equal to 30. 4.Patients with concurrent Hepatic Dysfunction or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (bronchial asthma and COPD) or major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Neurological disorders, Endocrinal disorders, etc.) or known cases of malignancy. 5.Uncontrolled DiabetesMellitus 6.Individuals taking concomitant medications that may have effect on blood pressure such as corticosteroids, NSAIDs, metoclopromide, bromocryptine, carbamazepine, anabolic steroids, etc. 7.Chronic smokers and history of substance abuse 8.Women who are planning for conception/ pregnant or lactating. 9.History of intake of any herbal formulation/ supplements to manage pre-hypertension 10.History of hypersensitivity to Phyllanthus emblica L.

Design outcomes

Primary

Measure	Time frame
Proportion of participants who develop hypertension (BP more than or equal to 140/90 mm Hg)Timepoint: Baseline to Week 12, Week 24	—

Secondary

Measure	Time frame
1.Change in the Systolic and Diastolic Blood Pressure assessed by digital sphygmomanometer (mean of three BP readings will be taken during every follow-up visit) 2.Change in 24-hour ambulatory systolic and diastolic blood pressure [Time Frame: Baseline, Week 12 , Week 24] 3.Changes in biomarkers associated with the pathogenesis of hypertension viz. ACE activity [Time Frame: Baseline, Week 12] 4.Change in pro-inflammatory markers viz. hs-CRP [Time Frame: Baseline, Week 12] 5.Changes in the Laboratory safety parameters viz. CBC, LFT, KFT, eGFR, lipid profile, Urine R&M [Time Frame: Baseline, Week 12] 6.Assessment of occurrence of treatment-emergent adverse events (TEAE) and no. of participants withdrawn from the study due to AEs [Time Frame: Baseline to Week 12] Timepoint: Week 4, 8, 12, and 24 from baseline	—

Measure

Time frame

1.Change in the Systolic and Diastolic Blood Pressure assessed by digital sphygmomanometer (mean of three BP readings will be taken during every follow-up visit) 2.Change in 24-hour ambulatory systolic and diastolic blood pressure [Time Frame: Baseline, Week 12 , Week 24] 3.Changes in biomarkers associated with the pathogenesis of hypertension viz. ACE activity [Time Frame: Baseline, Week 12] 4.Change in pro-inflammatory markers viz. hs-CRP [Time Frame: Baseline, Week 12] 5.Changes in the Laboratory safety parameters viz. CBC, LFT, KFT, eGFR, lipid profile, Urine R&M [Time Frame: Baseline, Week 12] 6.Assessment of occurrence of treatment-emergent adverse events (TEAE) and no. of participants withdrawn from the study due to AEs [Time Frame: Baseline to Week 12] Timepoint: Week 4, 8, 12, and 24 from baseline

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Countries

India

Contacts

Public ContactDr Harbans Singh

Regional Ayurveda Research Institute

dr.harbans@rediffmail.com09501248820

Outcome results