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Forskolin

Forskolin ProCorra.jpg

Ayu. 2011 Jan-Mar; 32(1): 59–65. 

doi: 10.4103/0974-8520.85729

PMCID: PMC3215419

PMID: 22131759

Clinical efficacy of Coleus forskohlii (Willd.) Briq. (Makandi) in hypertension of geriatric population

Madhavi Jagtap,1 H. M. Chandola,2 and  B. Ravishankar3

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Abstract

Hypertension is the most common psychosomatic disorder affecting 972 million people worldwide. The present clinical study deals with the effect of Makandi (Coleus forskohlii (Willd.) Briq.) Ghana vati and tablets of its powder in hypertension found in the geriatric age group (50-80 years). A total of 49 hypertensive patients fulfilling the diagnostic criteria were registered in two groups-Group I (Ghana vati) and Group II (Churna tablet). Out of 27 enrolled patients of group I, 21 patients completed the treatment. In Group II, out of 22 registered patients, a total of 20 patients completed the treatment. The effect of the therapy was assessed on the basis of changes in the systolic and diastolic blood pressures, in both sitting and supine positions; with Manasa Bhava Pariksha, Manasa Vibhrama Pariksha, symptomatology, geriatric signs and symptoms, and a brief psychiatric rating scale. Analysis of the results showed that the treatment in both the groups had been found to be good. It can be stated that Makandi, either in Ghana vati form or in churna tablet form, is an effective remedy for the treatment of hypertension. On analyzing the overall effect, 76.19% patients in Group I and 75.00% patients in Group II were mildly improved. Comparatively the overall treatment with group I was found to be better.

Keywords: Makandi, Coleus forskohlii, forskolin, Ghana vati, geriatric hypertension

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Introduction

Hypertension is an important public-health challenge worldwide due to its associated morbidity, mortality, and economical burden on society. Worldwide, it has been seen in about 972 million people in 2000, and the prevalence has been estimated to increase by about 60% to a total of 1.56 billion by the year 2025.[1] It has been reported that hypertension prevalence in India quadrupled in the urban as well as rural populations over a 50-year period, from the early 1950s to the late 1990s.[2,3] Hypertension as such is not described in Ayurverdic literature, however, the spectrum of disease hypertension is interpreted in terms of Raktavata, Raktagatavata, and in recent years as Vyana bala vaishymya/Vyana bala vriddhi in Ayurvedic parlance.

The disease is associated with increased obesity and aging population. India now has the second largest aged population in the world.[4] The incidence rate of hypertension increases with age in both men and women due to age-related changes like thickening of vessel wall, arteriosclerosis, and so on, leading to a decrease in elasticity and lumen of the vessels, and hence, increase in blood pressure. Moreover feeling of insecurity, stress, and anxiety, causes a disturbance in mental health and precipitates the disease, which is frequently seen in old age. Also it is stated that Jara Avastha (old age) is the Parihani Kala having Vata dosha in dominancy, which is the main dosha involved in the pathogenesis of hypertension. It is more common in men than in women up to the age 50 years, after which blood pressure rises in women and becomes equal to that seen in males. In later life pressures are higher in women.

The treatment of hypertension in modern science is palliative in nature. Although pharmacological treatments are effective for controlling blood pressure, they have adverse side effects. Lack of information regarding the etiology of most cases of hypertension has enhanced the search for effective anti-hypertensive agents. This approach has led to a further hunt into indigenous drugs, especially after the invention of very promising results of reserpine. For preservation of the health of vital organs, the use of medicinal herbs is the need of the hour. There are a number of herbs that are used as home remedies for common ailments. Such herbs are easily available, eco-friendly, cost-effective, and toxicity-free, due to their holistic approach.

Coleus forskohlii (Willd.) Briq., [synonym C. barbatus (Andr.) Benth.], belonging to the family Labiatae, Genus-Coleus, is an ancient root drug mentioned in Ayurvedic Materia Medica,[5,6] under the Sanskrit name ‘Makandi’. It is stated to have Agnidipana, Pachana, Pandu, Pliha, Shothhara, and other such properties. In the recent monographs of Indian Council of Medical Research,[7] it is described by the name Gandir, with a Gujarati name of ‘Garamar’. It is commonly known as Garmar in the Saurashtra region of Gujrat, and is extensively used as pickle in almost every home during its season, around the months of March to May of each year. The species is being cultivated in Gujarat, Maharashtra, and Karnataka. The traditional uses of the plant are also reported.[8] The root tubers are used traditionally as blood purifiers, hypotensives, diuretics, and so on.

In 1974, researchers first isolated[9] the diterpene, Forskolin, having blood pressure lowering and antispasmodic effects, from the roots, making it the only plant source thus far known having this substance. The therapeutic effects of this alkaloid ‘forskolin’ are well-documented[10] as being a hypotensive, antispasmodic, positive inotrophic, vasodilator, smooth muscle relaxant, anti-inflammatory, with anti-platelet aggregation, a bronchodilator, anti-glaucoma agent, anti-metastatic, and so on, due to its unique ability to activate the enzyme, Adenylate cyclase, in the absence of a functional guanine nucleotide regulatory protein.

Very few clinical and experimental trials have been done on the Churna of the root (as a whole). No study has been reported on the effect of Ghanavati form of the drug using root tuber. Though many pharmacological and few clinical studies have been carried out on active principle or isolated fractions of the drug. This type of treatment is always discouraged by Ayurveda, as it believes in total and positive health. When a fraction is isolated it acquires a pin-pointed action and also develops the risk of creating adverse effects. The whole drug contains various fractions in balance, with the least chance of developing adverse effect. The administration of the total drug is always preferred by Ayurveda, so as to interfere in the least with the natural composition and action. Considering all these points, the present clinical trial was undertaken with the aim of finding efficacy of this whole root tuber, in cases of hypertension.

Aims and objectives

The aims of the study was to evaluate the efficacy of Coleus forskohlii (Willd.) Briq. (Makandi) root (tuber) Ghana vatiand Churna tablet in hypertension observed in geriatric patients (age 50-80 years).

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Materials and Methods

Patients: Patients attending the O.P.D and I.P.D of the Department of Kayachikitsa and cases referred by other departments of the Institute for Post Graduate Teaching and Research in Ayurveda hospital, Gujarat Ayurved University, Jamnagar, fulfilling the criteria of inclusion were selected for the present study. An elaborative case taking proforma, incorporating all the aspects of the disease in Ayurvedic and Modern parlance was specially designed for the purpose.

Drugs: Makandi (Coleus forskohlii (Willd.) Briq.) root (tuber) - Ghana vati and tablets of its powder were prepared in the pharmacy of Gujarat Ayurved University, Jamnagar.

Diagnostic criteria: The standard diagnostic criteria of the World Health Organization (WHO)/International Society of Hypertension (ISH) (2004)[11] and Joint National Committee (JNC) VI[12] for Prevention, Detection, Evaluation, and treatment of High Blood Pressure was adopted in selecting patients for the study.

Inclusion criteria: Patients above 50 years and below 80 years of age, presenting with the classical symptoms of hypertension were selected for the study. Patients having systolic blood pressure >140 mm of Hg and </ = 180 mm of Hg and diastolic blood pressure >90 mm of Hg and </ = 110 mm of Hg were selected for the study.

Exclusion criteria: Patients below 50 years and above 80 years of age with systolic blood pressure <140 mm of Hg and >180 mm of Hg and diastolic blood pressure <90 mm of Hg and >110 mm of Hg were excluded from the study. Patients having major illness like severe diabetes Mellitus (DM), tuberculosis, major endocrine disorders, malignancies, Human immunodeficiency virus (HIV) or renal accelerated and malignant hypertension and other serious systemic illness were excluded from the study.

Investigation: Hematological investigations like Hemoglobin %, Total Leucocyte Count, Differential Leucocyte Count, Erythrocyte Sedimentation Rate, Packed Cell Volume, Total Red Blood Cell count and platelet count were done, as also urine and stool for routine and microscopic examination. Biochemical investigations like FBS, complete lipid profile, blood urea, serum creatinine, uric acid, and serum calcium were done, to rule out any other pathology. Serum Apolipoprotien B-100 was investigated as a biomarker for the elderly hypertensive patients.

Study design: It was a randomized clinical study. The study design was approved by the Institutional Ethics Committee. Informed consent was taken from the patients before including them in the trial.

Management of the patients

Drug dosage, duration, and method of administration:

 

  • Grouping: The selected patients were randomly divided into two groups:

  • Group-I — Patients of this group were given Makandi Ghana vati-500 mg two t.d.s. after breakfast, lunch, and dinner, for two months, with lukewarm water as anupana. In this group, out of a total of 27 registered patients, 21 completed the treatment, and the remaining six stopped against medical advice.

  • Group-II — Patients of this group were given Makandi Churna tablet-700 mg two t.d.s. after breakfast, lunch, and dinner for two months, with lukewarm water as anupana. In this group, a total of 22 patients were selected, out of which 20 completed the treatment and two stopped it against medical advice.

 

Psychological counseling was done for all patients in both the groups.

Pathya - Apathya: The patients were advised to follow correct dietary habits and avoid unhygienic, stale food, reduce intake of extra salt, avoid papada, chuttneys, pickles, and so on. Mild-to-moderate exercise as per their capacity was suggested. They were consulted for modification in diet and lifestyle, to rule out the causative factors of hypertension.

Follow-up: A follow-up study was carried out for one month.

Criteria for assessment

Changes in the subjective parameters of the specific rating scales were recorded at two-week intervals. Changes in systolic and diastolic blood pressures in both sitting and supine positions were assessed weekly. A specific rating scale for geriatric signs and symptoms,[13] Manasa Pariksha Bhava (Mental factor examination),[14] Manasa Vibhrama pariksha, for symptomatology,[15] and Brief Psychiatric Rating Scale[16] were utilized to assess the effect of the therapy. The total effect of the therapy in each patient was evaluated after completion of the treatment.

Criteria for the overall assessment of therapy

The total effect of the therapy was assessed considering the overall improvement in the signs and symptoms, reduction in blood pressure, and improvement on the ‘Brief Psychiatric Rating Scale’. After completion of the treatment course and in the follow-up period, the total effect was derived from the following formula:

 

 

 

Nutrients. 2015 Nov; 7(11): 9508–9522. 

Published online 2015 Nov 17. doi: 10.3390/nu7115483

PMCID: PMC4663611

PMID: 26593941

Coleus forskohlii Extract Supplementation in Conjunction with a Hypocaloric Diet Reduces the Risk Factors of Metabolic Syndrome in Overweight and Obese Subjects: A Randomized Controlled Trial

Hayley L. LoftusKatie J. AstellMichael L. Mathai, and  Xiao Q. Su*

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Abstract

Limited studies have shown that Coleus forskohlii extract may aid in weight management. This randomized, double blind placebo-controlled clinical study assessed the effects of supplementation with C. forskohlii extract on key markers of obesity and metabolic parameters in overweight and obese individuals. Thirty participants completed the trial and they were randomly assigned to receive either 250 mg of C. forskohlii extract (n = 15) or a placebo twice daily for 12 weeks. All participants were advised to follow a hypocaloric diet throughout the study. Body weight, body mass index (BMI), waist and hip circumference, and waist to hip ratio, were monitored fortnightly. Dietary intake was assessed at the baseline and weeks 4, 8 and 12. Appetite was assessed using visual analogue scales and blood samples were analyzed for plasma lipids, ghrelin, leptin, glucose and insulin at the baseline and end of the intervention. Significant reductions to waist and hip circumference (p = 0.02; p = 0.01, respectively) were recorded in both experimental and placebo groups after the 12 week intervention. Furthermore, high density lipoprotein-cholesterol (HDL-C) was significantly increased (p = 0.01) in both groups. The experimental group showed a favorable improvement in insulin concentration and insulin resistance (p = 0.001; 0.01 respectively) compared to the placebo group. These findings suggest that C. forskohlii extract in conjunction with a hypocaloric diet may be useful in the management of metabolic risk factors.

Keywords: Coleus forskohlii, appetite, waist circumference, hip circumference, metabolic parameters

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1. Introduction

Metabolic syndrome is a common cardio-metabolic disorder that is characterized by the simultaneous occurrence of cardiovascular risk factors including central obesity, dyslipidemia, hyperglycemia and hypertension [1]. Central obesity is a major predisposing factor to the development of metabolic syndrome and is a key component of metabolic syndrome [2,3,4]. The exact mechanism by which metabolic syndrome develops is not yet fully understood but it appears to be related to insulin resistance and excessive free fatty acid release from intra-abdominal adipocytes [5,6,7]. It is also believed that a pro-inflammatory and pro-thrombotic state contribute to the pathogenesis of the syndrome [8]. Metabolic syndrome poses a major health risk for the development of cardiovascular disease (CVD) and type II diabetes mellitus (T2DM), thus an effective therapeutic approach is in high demand for those who are at risk [9]. The majority of individuals affected with metabolic syndrome are overweight or obese and therefore treatment is primarily focused on weight reduction [10,11,12].

Lifestyle interventions such as dietary modification and physical activity remain the cornerstone of weight loss treatment. In theory, reducing energy intake and increasing energy expenditure will elicit weight loss [10]. However, obesity is a multifactorial condition encompassing complex environmental and genetic influences leading to overconsumption and reduced physical activity making weight loss a challenging issue [13]. As the prevalence of overweight and obesity continues to rise at an alarming rate, more effective weight-control therapies are required [14]. The availability and popularity of natural weight loss supplements has increased drastically over recent years. Coleus forskohlii auct. (Plectranthus barbatus Andrews) extract is among those natural products that shows promising therapeutic anti-obesity potential [15].

Coleus forskohlii auct. is a perennial plant of the Lamiaceae (mint) family and is native to Nepal, Thailand and India. Forskolin is the major active constituent of C. forskohlii which is of clinical interest [16]. Forskolin (7β-Acetoxy-8, 13-epoxy-1α, 6β, 9 α-trihydroxy-labd-14-ene-11-one) (Figure 1) is a labdane diterpene that was first isolated from the plant in 1974. Forskolin is extracted from the tuberous roots of the plant and thus far, C. forskohlii is the only species known to contain significant amounts of the bioactive component [17]. It has been documented that forskolin increases the rate of lipolysis via cyclic adenosine monophosphate (cAMP) accumulation by mechanisms independent of hormonal stimulation both in vitro [18,19] and in animal models [20,21]. Furthermore, forskolin also directly activates hormone sensitive lipase by phosphorylation of protein kinase A resulting in further lipolysis and release of free fatty acids [19].

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