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Efficacy of Khār-i-khasak (Tribulus terrestris Linn.) in prehypertension: a randomized, double-blind, placebo-controlled trial.

  • 2021-04-01
  • Journal of complementary & integrative medicine 18(4)
    • Mansoor Ahmad Siddiqui
    • Malik Itrat
    • Abdul Mobeen
    • Md Imran Khan

Study Design

Type
Randomized Controlled Trial (RCT)
Population
Prehypertensive individuals over 18 years of age
Methods
Randomized, double-blind, placebo-controlled, clinical trial; administered powdered dried fruits of Khār-i-khasak (6g) and matched placebo (6g) in three divided doses for two months
Blinding
Double-blind
Duration
two months

Background

Prehypertension is a state of above-normal blood pressure that does not meet the criteria for the diagnosis of hypertension and its prevalence estimated in population-based samples ranges from 22 to 52%. It conveys potentially many deleterious consequences such as high risk of progression to hypertension and cardiovascular disease later in life.

Objectives

The present study was conducted to evaluate the blood pressure-lowering effect of Khār-i-khasak (Tribulus terrestris Linn.) in prehypertensive individuals.

Methods

This randomized, double-blind, placebo-controlled, clinical trial was conducted at the National Institute of Unani Medicine, Hospital, Bengaluru, after approval by the Institutional Ethics Committee. Prehypertensive individuals over 18 years of age were enrolled after obtaining their written informed consent and were randomly allocated to the test or placebo group. The test and placebo groups were administered powdered dried fruits of Khār-i-khasak (6g) and matched placebo (6g) in three divided doses for two months respectively. The efficacy assessment was determined by changes in systolic and diastolic blood pressures.

Results

Both systolic and diastolic blood pressure showed a significant decline in the test group (p<0.001) as compared to the placebo group. The average decline in systolic/diastolic blood pressure was -7.7/5.5 mmHg in the test group and -1.9/0.2 mmHg in the placebo group. During the post-therapy follow-up period, no prehypertensive developed full-blown hypertension in either group. Safety parameters were found to be within normal limits.

Conclusions

The test drug Khār-i-khasak (T. terrestris Linn.) was found to be effective and safe in lowering blood pressure compared to placebo in prehypertensive individuals.

Research Insights

  • Tribulus→Reduced Diastolic Blood Pressure

    Both systolic and diastolic blood pressure showed a significant decline in the test group (p<0.001) as compared to the placebo group. The average decline in systolic/diastolic blood pressure was -7.7/5.5 mmHg in the test group

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    6 g/day in three divided doses
  • Tribulus→Reduced Progression to Hypertension

    During the post-therapy follow-up period, no prehypertensive developed full-blown hypertension in either group.

    Effect
    Neutral
    Effect size
    Small
    Dose
    6 g/day in three divided doses
  • Tribulus→Reduced Systolic Blood Pressure

    Both systolic and diastolic blood pressure showed a significant decline in the test group (p<0.001) as compared to the placebo group. The average decline in systolic/diastolic blood pressure was -7.7/5.5 mmHg in the test group

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    6 g/day in three divided doses

Adverse Events Reported

  • Tribulus→Overall tolerability

    Safety parameters were found to be within normal limits.

    Finding
    Reported
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