Comparison of Murraya koenigii- and Tribulus terrestris-Based Oral Formulation Versus Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Men Aged >50 Years: A Double-Blind, Double-Dummy, Randomized Controlled Trial
Sengupta G.,Nil Ratan Sircar Medical College |
Hazra A.,Jawaharlal Institute of Postgraduate Medical Education & Research |
Kundu A.,Jawaharlal Institute of Postgraduate Medical Education & Research |
Ghosh A.,East India Pharmaceutical Works Ltd.
Background: Drug treatment can defer surgical intervention in benign prostatic hyperplasia (BPH), a common disorder in elderly men, and is widely practiced. Various herbal formulations have been used for the treatment of BPH, but few have been compared with established modern medicines in head-to-head clinical trials. Objective: We compared the effectiveness and tolerability of an oral formulation, comprising standardized extracts of Murraya koenigii and Tribulus terrestris leaves being marketed in India under Ayurvedic license, versus tamsulosin in the treatment of symptomatic BPH. Methods: A double-blind, double-dummy, parallel-group, randomized controlled trial was conducted with treatment-naive ambulatory patients with BPH aged >50 years. Patients received either the plant drug in a dose of 2 capsules BID or tamsulosin 400 μg once daily for 12 weeks with 2 interim follow-up visits at the end of 4 and 8 weeks. The double-dummy technique was used to ensure double-blinding. The primary effectiveness measure was reduction in the International Prostate Symptom Score (IPSS). Proportion of patients becoming completely or relatively symptom free (IPSS <8), change in prostate volume (assessed by using ultrasonography conducted by a radiologist blinded to the nature or duration of treatment), and peak urinary flow rate (assessed by using uroflowmetry) were secondary measures. Treatment-emergent adverse events, changes in weight, vital signs, and routine laboratory safety parameters were recorded. Results: Forty-six patients were randomized (23 per group); 19 completed all study visits in the plant drug group and 21 in the tamsulosin group. However, applying modified intention-to-treat criterion, 23 and 21 patients, respectively, were considered for effectiveness analysis. Mean (SD) age and baseline weight were 58.5 (14.0) years and 57.5 (10.5) kg in the plant drug arm, and 62.9 (6.3) years and 59.8 (9.9) kg in the tamsulosin arm, respectively. Median (interquartile range) symptom duration was 12.0 (12.0-24.0) months and 15.0 (12.0-24.0) months, respectively, in the 2 arms. These differences were not statistically significant. IPSS (median [interquartile range]) declined from 17.0 (12.0-19.0) to 9.0 (5.0-13.0) with the plant drug and from 14.0 (11.0-18.0) to 8.0 (6.0-13.0) with tamsulosin after 12 weeks of treatment. The decline was individually significant in both groups (both, P < 0.001), but intergroup values showed no statistically significant difference at any point of time. IPSS <8 at study end was achieved by 10 and 7 patients, respectively, in the 2 arms (P = 0.548). The plant drug reduced prostate volume from 33.5 (26.2-45.9) mL to 31.6 (26.1-37.5) mL (P = 0.040). The corresponding reduction with tamsulosin, from 41.3 (29.4-51.3) mL to 39.9 (32.6-52.3) mL, was not statistically significant. Peak urinary flow rate did not change appreciably. Mild joint pain was the most common adverse event in both arms. No serious events were encountered. Compliance was satisfactory. Conclusions: These findings suggest that the M koenigii- and T terrestris-based formulation significantly lowered IPSS scores in the initial treatment of symptomatic BPH. Further trials are needed to determine if the beneficial effect is sustained beyond the 12-week observation period of this trial. © 2011 Elsevier HS Journals, Inc. Source
Das M.M.,East India Pharmaceutical Works Ltd. |
Mukherjee T.,East India Pharmaceutical Works Ltd.
The objective of the review article is to bring out the differences between the Schedule L1, Drugs and Cosmetics Act, 1940, Government of India and the WHO Good Practices For Pharmaceutical Quality Control Laboratories, World Health Organisation. This will be particularly useful to the laboratories that already comply with the requirements of Schedule L1 and want to move ahead towards WHO compliance. Rules laid by Schedule L1 is terse and minimum with an objective to improve the reliability of data without much adding to the cost to the company, particularly for the small to medium scale pharmaceutical industries in India. On the other hand, WHO eyes towards every small aspects of and related to the laboratory procedure with a view to assure the output scientifically proof. Source
Chowdhury S.,East India Pharmaceutical Works Ltd. |
Das S.,East India Pharmaceutical Works Ltd. |
Bhattacharjee D.,East India Pharmaceutical Works Ltd. |
Saha P.K.,East India Pharmaceutical Works Ltd. |
And 2 more authors.
Indian Journal of Natural Products and Resources
Prebiotics are dietary substances that mostly consist of non-starch polysaccharides and oligosaccharides that nurture a selected group of microorganisms residing in the human intestine. These components are poorly hydrolyzed by our digestive enzymes. Prebiotics preferentially favour the growth of probiotic organisms like Lactobacillus and Bifidobacterium that are helpful in gut health maintenance, colitis prevention, cancer inhibition, immunopotentiation, cholesterol removal, reduction of cardiovascular disease, prevention of obesity and constipation. The natural sources of prebiotics are certain fruits and vegetables like asparagus, banana, chicory, garlic, onion, wheat and tomato. Considering increasing market demand of prebiotics, commercial production of them is standardized from wastes of food industries as well as from other sources. Due to their therapeutic support and history of safe use, fructo-oligosaccharides and galacto-oligosaccharides are now widely used for pharmaceutical formulations, combined with probiotics. © 2015, Indian Journal of Natural Products and Resources. All right reserved. Source