In another study published in the Japanese Heart Journal a double-blind, parallel group study was conducted in 43 men and women suffering from hypertension to evaluate the antihypertensive effect of Abana and compare it with that of methyldopa (M-DOPA). Twenty one patients received 800 mg tds of Abana and 22 patients received 250 mg tds of M-DOPA for 4 weeks. Blood pressure and pulse rate were recorded at weekly intervals. Relevant clinical and biochemical investigations were carried out before and after treatment.
In patients treated with Abana, there was a significant fall both in systolic B.P. (from 167 ± 3.73 to 145 ± 6.11 mmHg) and in diastolic B.P. (from 110 ± 1.86 to 91 ± 3.04 mmHg) at the end of 4 weeks. Similarly in patients treated with M-DOPA, systolic blood pressure was significantly reduced from 165 ± 4.92 to 146 ± 4.9 mmHg and diastolic blood pressure was reduced from 106 ± 2.74 to 96 ± 2.67 mmHg after 4 weeks. The onset of antihypertensive effect was earlier and there was a higher percentage of responders (80%) in the Abana-treated group. None of the patients had clinically or biochemically significant side effects. The results of this study suggest that therapy with Abana proved highly effective in hypertensive patients
Double-blind comparative clinical trial of Abana and Simvastatin in Hyperlipidaemia
Venkataramaiah, H., M.D., D.M. (Cardiology), Professor of Cardiology, Jayadeva Institute of Cardiology, Jayanagar East End, Bangalore, India.
[Corresponding author: Kala Suhas Kulkarni, M.D., Medical Advisor, R&D Center, The Himalaya Drug Company, Makali, Bangalore, India]
Observational studies have established hyperlipidaemia as an independent risk factor for coronary artery disease. It is now proved that hyperlipidaemia is an independent risk factor for ischemic stroke. Additional evidence from the prospective studies have shown the relationship between plasma cholesterol levels and risk of stroke. Reduction in the plasma cholesterol is accompanied by significant decrease in the incidence of coronary artery disease and stroke.
Data from individual randomised trials and meta-analyses of randomised trials consistently show a reduction in risk for both fatal and nonfatal coronary heart disease following primary and secondary prevention. A recent comprehensive overview by Law and colleagues incorporated data from 28 trials of cholesterol reduction, including 6 multiple intervention trials that each had a cholesterol-reducing arm. This overview indicated that a 10% reduction in serum cholesterol level resulted in highly significant reductions mortality from coronary heart disease. These data from randomised trials are consistent with observational data when treatment lasts 5 years or more. A 10% reduction in cholesterol levels was associated with a 25% reduction in coronary events among persons treated for more than 5 years. These findings from meta-analyses are also supported by recent reports from the Scandinavian study and the West of Scotland Coronary Prevention Study.
Herbs have been used since ancient times for reducing body lipids. Reports on all garlic studies performed, found cholesterol was lowered by an average of 9-12% over a one-to-four month period9. Guggul, a mixture of substances taken from the plant Commiphora mukul, is an approved treatment for elevated cholesterol in India and has been a mainstay of the Ayurvedic approach in preventing atherosclerosis. One trial studying the effects of guggul reported that serum cholesterol dropped by 17.5%10. In another report comparing guggul to the drug clofibrate, average fall in serum cholesterol was slightly greater in the guggul group while HDL cholesterol rose in 60% of people responding to guggul, while clofibrate treatment did not elevate HDL. Wild yam another herb commonly used has also been reported to raise HDL cholesterol in preliminary research12. With the above leads we planned a double-blind comparative clinical study using Abana and Simvastatin.
MATERIALS AND METHODS
Seventy patients were evaluated for general health and lipid profile through a medical history and a thorough physical examination. Patients with secondary hyperlipidaemia, alcoholism, or body weight more than 15% above the ideal for their height were excluded from the study. Baseline
cholesterol and triglycerides of estimation were carried out. The patients showing serum total cholesterol levels more than 200 mg/dL or serum triglyceride levels more than 200 mg/dL were included in the study.
After screening fifty patients qualified for the study, their ages ranged from 29 to 64 years, with a median of 46. There were 37 male and 13 female patients. Each patient underwent routine hematological and biochemical laboratory investigations. Patients were asked not to eat any food, except for water, for 12 to 14 hours before taking blood samples. Routine urine analysis and electrocardiography was also carried out. The study planned was double blind, randomized comparative study for 8 weeks. The written and informed consent was obtained from all the patients. Patients took 2 capsules of the drug before breakfast and at bedtime. The patients had to visit every 2 weeks for 8 weeks. A registered dietician interviewed the patients and instructed them to have diet with low cholesterol and saturated fats.
The clinical side effects if any were recorded at each visit and discussed with the patient to know the nature, severity and frequency. Patients were seen by the same dietician at every clinic visit throughout the study and were instructed to follow the same diets and to maintain weight, physical activity levels and smoking frequency for the duration of the study. To evaluate diet compliance, patients made written records of the quantity and type of food consumed in 4 consecutive days, including a weekend, between visits. These food diaries were kept on special forms that were then translated into computer language and analyzed by a program designed for that purpose. Patients reported their usual physical activity and smoking habits on a special card at every visit. All but three patients did not smoke cigarettes. Repeat laboratory investigations and electrocardiography were done after completion of the study.
Concomitant medications were monitored throughout the study. Twenty-three patients took no other drugs, 11 took asprin, acetaminophen, or both, 8 took antihistamines / antiallergic preparations, vitamins, or mineral supplements, 7 took minor tranquilizers, sedatives, or laxatives, 4 took nonsteroidal anti-inflammatory drugs, 4 took antacids or anticholinergic drugs, and 2 took antibiotics. The results were analyzed using paired ‘t’ test.
Of the 50 patients who entered the active-treatment phase of the study, 3 were excluded because of non-compliance. The patients followed fairly uniform dietary patterns during the trial and their compliance was assured by routine interviews with the dietician and review of the computer’s analysis of dietary records at every clinic visit. Routine follow-up by the dietician resulted in good overall dietary compliance and accounted for the attainment, in many patients of normal cholesterol levels in both the drug treatment. Results of those patients taking Abana showed a reduction of cholesterol from 215.3 ± 7.42 mg/dl to 192.3 ± 9.08 mg/dl. Reduction in cholesterol from 204.2 ± 8.43 to 157.0 ± 7.54 mg/dl occurred with Simvastatin. Triglycerides levels were also reduced from 216.0 ± 26.37 mg/dl to 187.7 ± 21.28 mg/dl and 214.7 ± 34.09 to 173.5 ± 23.23 mg/dl with Abana and Simvastatin respectively. In HDL, levels were increased in a similar fashion with Abana and Simvastatin treatment. Although, the rise in HDL cholesterol was similar in both the drugs, Simvastatin produced increase of HDL-cholesterol marginally higher than the Abana. However considering the risks involved in taking statin drugs, Abana is the safer alternative
Radioprotective effect of abana, a polyherbal drug following total body irradiation.
Baliga MS, Jagetia GC, Venkatesh P, Reddy R, Ulloor JN.
Br J Radiol. 2004 Dec;77(924):1027-35.
PMID: 15569645 [PubMed - indexed for MEDLINE]
The evaluation of nitric oxide scavenging activity of certain herbal formulations in vitro: a preliminary study.
Jagetia GC, Rao SK, Baliga MS, S Babu K.
Phytother Res. 2004 Jul;18(7):561-5.
PMID: 15305317 [PubMed - indexed for MEDLINE]
Effect of abana (a herbal preparation) on the radiation-induced mortality in mice.
Jagetia GC, Baliga MS, Aruna R, Rajanikant GK, Jain V.
J Ethnopharmacol. 2003 Jun;86(2-3):159-65.
PMID: 12738080 [PubMed - indexed for MEDLINE]
Effect of abana an ayurvedic formulation, on lipid peroxidation in experimental myocardial infarction in rats.
Sasikumar CS, Devi CS.
Indian J Exp Biol. 2000 Aug;38(8):827-30.
PMID: 12557918 [PubMed - indexed for MEDLINE]
The herbal preparation abana protects against radiation-induced micronuclei in mouse bone marrow.
Jagetia GC, Aruna R.
Mutat Res. 1997 Sep 18;393(1-2):157-63.
PMID: 9357573 [PubMed - indexed for MEDLINE]
Effect of Abana and Metoprolol on serum lipid profile in rabbits fed hyperlipidemic diet.
Pachori SB, Gupta M, Pant MC.
Indian J Physiol Pharmacol. 1993 Jul;37(3):252-4.
PMID: 8276510 [PubMed - indexed for MEDLINE]
Influence of Abana on experimental atherogenesis in hypercholesterolemic rabbits.
Tiwari AK, Gode JD, Dubey GP.
Jpn Heart J. 1993 Jul;34(4):451-8.
PMID: 8246351 [PubMed - indexed for MEDLINE]
Effect of Abana on ventricular function in ischemic heart disease.
Antani JA, Kulkarni RD, Antani NJ.
Jpn Heart J. 1990 Nov;31(6):829-35.
PMID: 2084279 [PubMed - indexed for MEDLINE]
Double blind comparative trial of Abana and methyldopa for monotherapy of hypertension in Indian patients.
Dadkar VN, Tahiliani RR, Jaguste VS, Damle VB, Dhar HL.
Jpn Heart J. 1990 Mar;31(2):193-9.
PMID: 2192099 [PubMed - indexed for MEDLINE]
Effects of Abana, an Ayurvedic preparation, on rabbit atrium and intestine.
Pasnani JS, Hemavathi KG, Gulati OD, Rajani AP.
J Ethnopharmacol. 1988 Dec;24(2-3):287-302.
PMID: 3253495 [PubMed - indexed for MEDLINE]
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