Efficacy of Khār-i-khasak (Tribulus terrestris Linn.) in prehypertension: a randomized, double-blind, placebo-controlled trial
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Mansoor Ahmad Siddiqui
,
Abdul Mobeen
Abstract
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.
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Research funding: National Institute of Unani Medicine, Bengaluru, Karnataka, India.
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Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
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Competing interests: No funding organizations played a role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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Ethical statement: The study was approved by the Institutional Ethics Committee (registration no. NIUM/IEC/2016-17/033/IMR/01). This study was registered at the clinical trial registry of India vide registration no. CTRI/2018/05/014290. All participants signed an informed consent form before participating in the trial. The study was conducted in accordance with the Helsinki declaration, and the Good clinical practice guidelines of Ministry of Health and Family Welfare, Government of India.
References
1. Nesbitt, SD. Prehypertension: does it still matter? Hypertens J 2016;2:109–12.10.5005/jp-journals-10043-0041Search in Google Scholar
2. Ale, OK, Ajuluchukwu, JN, Ok, DA, Mbakwem, AC. Impact of prehypertension on left ventricular mass and QT dispersion in adult black Nigerians. Cardiovasc J Afr 2014;25:78–82. https://doi.org/10.5830/CVJA-2014-010.Search in Google Scholar
3. Fuchs, SC, Poli-de-Figueiredo, CE, José A. Figueiredo Neto, JA, Scala, LC, Whelton, PK, Mosele, F, et al.. Effectiveness of chlorthalidone plus amiloride for prevention of hypertension: the PREVER-prevention randomized clinical trial. J Am Heart Assoc 2016;5:e004248. https://doi.org/10.1161/JAHA.116.004248.Search in Google Scholar
4. Vasan, RS, Larson, MG, Leip, EP, Kannel, WB, Levy, D. Assessment of frequency of progression to hypertension in non-hypertensive participants in the Framingham heart study: a cohort study. Lancet 2001;358:1682–6. https://doi.org/10.1016/S0140-6736(01)06710-1.Search in Google Scholar
5. Mini, GK, Sarma, PS, Thankappan, KR. Risk of progression to hypertension from prehypertension and normal blood pressure: results from a prospective cohort study among industrial workers in Kerala, India. Heart Mind 2018;2:106–10. https://doi.org/10.4103/hm.hm_21_19.Search in Google Scholar
6. Ferguson, TS, Younger, N, Tulloch-Reid, MK, Lawrence-Wright, MB, Forrester, TE, Cooper, RS, et al.. Progression from prehypertension to hypertension in a Jamaican cohort: incident hypertension and its predictors. West Indian Med J 2010;59:486–93.Search in Google Scholar
7. Kim, SJ, Lee, J, Nam, CM, Jee, SH, Park, IS, Lee, KJ, et al.. Progression rate from new-onset pre-hypertension to hypertension in Korean adults. Circ J 2011;75:135–40. https://doi.org/10.1253/circj.CJ-09-0948.Search in Google Scholar
8. Sarah, L, Clarke, R, Qizilbash, N, Peto, R, Collins, R. Age specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002;360:1903–13. https://doi.org/10.1016/s0140-6736(02)11911-8.Search in Google Scholar
9. Julius, S, Nesbitt, SD, Egan, BM, Weber, MA, Michelson, EL, Kaciroti, N, et al.. Trial of preventing hypertension (TROPHY). Feasibility of treating pre-hypertension with an angiotensin–receptor blocker. N Engl J Med 2006;354:1685–97. https://doi.org/10.1056/NEJMoa060838.Search in Google Scholar
10. Luders, S, Schrader, J, Berger, J, Unger, T, Zidek, W, Böhm, M, et al.. The PHARAO study: prevention of hypertension with the angiotensin converting enzyme inhibitor ramipril in patients with high normal blood pressure: a prospective, randomized controlled prevention trial of the German hypertension league. J Hypertens 2008;26:1487–96. https://doi.org/10.1097/HJH.0b013e3282ff8864.Search in Google Scholar
11. Kausar, H, Faisal, S, Alvi, R. Concept of hypertension (Zaghtuddam qavi) in Unani system of medicine: a comprehensive review. Res Rev J Pharmacol 2019;9:14–21.Search in Google Scholar
12. Parveen, SF, Siddiqui, MA, Qaumri, MA, Khalil, A, Alam, MA. Concept and management of hypertension: a review. Int J Unani Integrat Med 2017;1:17–20.10.33545/2616454X.2017.v1.i1a.5Search in Google Scholar
13. Khan, QA, Khan, AA, Jabeen, A, Jahangir, U, Khalid, M, Ansari, S. Essential hypertension: a co-relational approach in Unani medicine. Int J Pharmacogn 2016;3:240–5. https://doi.org/10.13040/IJPSR.0975-8232.3(6).240-45.Search in Google Scholar
14. Khare, CP. Indian medicinal plants: an illustrated dictionary. Springer Science & Business Media; 2008:669 p.10.1007/978-0-387-70638-2Search in Google Scholar
15. Kabeeruddin, M. Makhzanal Mufradat. New Delhi: Eijaz Publishing House; YNM:203–4 pp.Search in Google Scholar
16. Anonymous. The Unani pharmacopoeia of India. Part-I, vol. I. New Delhi: Ministry of Health and Family Welfare, Department of AYUSH, Government of India; 2007:52–3 pp.Search in Google Scholar
17. Ghani, N. Khazainul Advia. New Delhi: Idara Kitab-us-Shifa; YNM: 1156–8 pp.Search in Google Scholar
18. Rizwan, M, Khan, AA. Assessment of efficacy of sankhahuli (Convolvulus pluricaulis Chois.) and gokhru (Tribulus terrestris) in the management of hypertension. Indian J Tradit knowl 2014;13:313–8.Search in Google Scholar
19. Charan, J, Biswas, T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med 2013;35:121–6.10.4103/0253-7176.116232Search in Google Scholar
20. Moreira, LB, Fuchs, SC, Wiehe, M, Gus, M, Moraes, RS, Fuchs, FD. Incidence of hypertension in Porto Alegre, Brazil: a population-based study. J Hum Hypertens 2008;22:48–50. https://doi.org/10.1038/sj.jhh.1002252.Search in Google Scholar
21. Murthy, AR, Dubey, SD, Tripathi, K. Anti-hypertensive effect of Gokshura (Tribulus terrestris Linn.) A clinical study. Ancient Sci Life 2000;XIX:139–45.Search in Google Scholar
22. Sharifi, AM, Darabi, R, Akbarloo, N. Investigation of antihypertensive mechanism of garlic in 2K1C hypertensive rat. J Ethnopharmacol 2003;86:219–24. https://doi.org/10.1016/S0378-8741(03)00080-1.Search in Google Scholar
23. Ojha, SK, Nandave, M, Arora, S, Narang, R, Dinda, AK, Arya, DS. Chronic administration of Tribulus terrestris Linn. Extract improves cardiac function and attenuates myocardial infarction in rats. Int J Pharmacol 2008;4:1–10. https://doi.org/10.3923/ijp.2008.1.10.Search in Google Scholar
24. Phillips, OA, Mathew, KT, Oriowo, MA. Antihypertensive and vasodilator effects of methanolic and aqueous extracts of Tribulus terrestris in rats. J Ethnopharmacol 2006;104:351–5. https://doi.org/10.1016/j.jep.2005.09.027.Search in Google Scholar PubMed
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