The effect of a herbal formulation on the incidence and severity of upper respiratory symptoms in healthy volunteers: an open-label, randomised controlled clinical trial

Goonaratna, Colvin; Sooriyarachchi, M. R.

doi:10.4038/cmj.v57i1.4197

Cited by 4 publications

(5 citation statements)

References 17 publications

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“…These two ingredients are also constituents of the commercially available formulations called “Paspanguwa” along with three other plants parts, Zingiber officinale Roscoe., Oldenlandia corymbosa L., and Solanum surattense Burm.f.) and also in another commercial formulation called Samahan which is a combination of 14 ingredients including these two [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

Immunomodulatory Activity of a Traditional Sri Lankan Concoction of Coriandrum sativum L. and Coscinium fenestratum G.

Kothalawala

Edward

Harasgama

et al. 2020

Evidence-Based Complementary and Alternative Medicine

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Objective. To investigate the immunomodulatory activity of a traditional Sri Lankan concoction of Coriandrum sativum L. and Coscinium fenestratum (Gaertn.) Colebr., which is a Sri Lankan traditional medicine used to relieve inflammation and cold. Methods. In vivo anti-inflammatory activity was tested using carrageenan-induced rat paw-edema model. Mechanism of anti-inflammatory activity was assessed by investigating the production of nitric oxide (NO), expression of iNOS enzyme, and reactive oxygen species (ROS) by rat peritoneal cells. The membrane stabilizing activity was also tested. The antibody response was determined by assessing the specific haemagglutination antibodies raised against sheep red blood cells. Results. The three doses of freeze-dried concoction used ((human equivalent dose (HED)—183 mg/kg) 2 × HED and 1/2HED; n = 6 rats/group) showed significant inhibition of paw edema compared to water control at 3rd–5th hours (p<0.05). Both HED and 1/2HED exhibited marked anti-inflammatory activity (72–83% inhibition at 4th-5th hours; p<0.05). The HED of the concoction showed significant inhibition of NO (77.5 ± 0.73%, p<0.001) and ROS production (26.9 ± 2.55%; p<0.01) by rat peritoneal cells. Inhibition of NO production in the concoction treated rat peritoneal cells was confirmed by the lack of iNOS expression. The concoction also exhibited significant membrane stabilizing activity (IC50 = 0.0006 μg/ml; p=0.001). HED resulted in a significantly high induction of specific antibody production against SRBC antigens as detected by SRBC haemagglutination assay (mean day 14 titers 253.3 compared to control: 66.7) (p<0.01). Conclusions. The traditional Sri Lankan concoction of C. sativum and C. fenestratum demonstrated potent in vivo anti-inflammatory activity, significant reduction of ROS, and NO production by rat peritoneal cells and the lack of iNOS expression confirmed the low NO production. The increased membrane stability also supports the anti-inflammatory activity of the concoction. Further, this concoction induced a significantly high antibody response reflecting its immunostimulatory activity. Together these results scientifically validate the therapeutic use of the concoction of C. sativum and C. fenestratum in Sri Lankan traditional medicinal system for immunomodulatory effects.

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Section: Introductionmentioning

confidence: 99%

Immunomodulatory Activity of a Traditional Sri Lankan Concoction of Coriandrum sativum L. and Coscinium fenestratum G.

Kothalawala

Edward

Harasgama

et al. 2020

Evidence-Based Complementary and Alternative Medicine

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“…LS has been previously shown to have protection against upper respiratory symptoms and hence it is currently widely used as a prophylactic agent [ 8 ]. Findings of the present study on rapid and enhanced gene expression of the co-stimulatory molecules leading to T-cell dependent B cell activation resulting in an effective IgG response supports the previous findings on the prophylactic effect of LS.…”

Section: Discussionmentioning

confidence: 99%

“…Its HPLC profile is provided as supplementary material . LS has been shown to have potent clinical effect in reducing the incidence, incidence over time and severity of fifteen upper respiratory symptoms [ 8 ]. Our previous studies have shown that LS possesses potent anti-inflammatory activity as shown by the significant reduction in in vivo anti-inflammatory activity (rat paw-edema model) and in inducing several cellular immune mechanisms contributing to anti-inflammatory activity such as inhibition of rat peritoneal phagocytic cell migration, production of reactive oxygen species (O 2 - assessed using quantitative nitroblue tetrazolium (NBT) assay) and reactive nitrogen species (NO 2 - assessed using Griess assay) and inducible nitric oxide synthase gene expression (assessed using reverse transcription polymerase chain reaction (RT-PCR) in rat peritoneal cells (unpublished data).…”

Section: Introductionmentioning

confidence: 99%

Increased expression of co-stimulatory molecules and enhancement of the IgG response in rats orally administered with a polyherbal formulation

Ranaweera

Edward

Abeysekera

et al. 2022

Journal of Ayurveda and Integrative Medicine

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Background Link Samahan ® (LS) is a standardized modern formulation of a polyherbal preparation used in the indigenous system of medicine in Sri Lanka. Objective Evaluation of the immunostimulatory activity of LS and the molecular mechanisms that modulate the humoral immune response. Material and methods Immunostimulatory activity of LS was tested in rats following oral administration on days 1-5 and 15-19 and immunization with bovine serum albumin (BSA) on day 1 and 15. Anti-BSA IgM and IgG response in rats treated with LS, water and sugar (as controls) were compared on days 0-35, using ELISA. The expression of co-stimulatory molecules on lymphocytes was assessed on days 0-8 and days 14-22 using RT-qPCR. Results IgM and IgG levels of LS-treated rats were increased significantly by day 7 and 21 respectively compared to controls (p < 0.05). IgG response of LS-treated group reached a higher magnitude compared to its IgM response. Gene expression of CD28 and CD40L on T cells (4.9-5.1 fold) and CD80, CD86 and CD40 on APCs (2.4-3.1 fold) were induced significantly by day 2 compared to their expression on day 0 (p < 0.05). The expression levels of CD28 and CD40L on day 2-4 and 16-18 were similar while the expression of CD80, CD86 and CD40 on day 16-18 was higher (3.7-5.1 folds) compared to their levels on day 2-4 (2.4-3.2). Conclusions These findings support an adjuvant effect of LS contributing to its immunostimulatory activity and increased expression of co-stimulatory molecules that contribute to boosting immune response.

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“…However, this formulation had not been registered as a herbal medicine by the Department of Ayurveda at the time of the RCT or its publication, as far as I have been able to ascertain. More recently two other RCTs, one with a genuinely herbal toothpaste [20], and another with a new formulation for colds and catarrh [21] have been published. The former significantly reduced salivary anaerobic bacterial counts, plaque index, and gingival bleeding in regular users, and the latter significantly reduced the incidence of 15 previously validated [22] and common upper respiratory symptoms, their incidence over time, and severity in healthy volunteers.…”

Section: Leading Articlementioning

confidence: 99%

Clinical research with traditional herbal medicines

Goonaratna

2013

Ceylon Med. J.

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Clinical research with traditional herbal medicinesEvidence-based medicine (EBM) is the new nostrum, and the randomised controlled trial (RCT) is the chosen device for buttressing its evidence base. Evidence, in the context of decision-making about therapeutic interventions, serves one purpose: it is the medium of establishing their efficacy for clinicians involved in the care of patients' life and health, and their rightness for experts charged with the responsibility for taking decisions with regard to therapeutic guidelines, public health interventions and health care systems.The long-standing dispute about the nature of science and scientific method, with respect to the inductive and deductive approaches to scientific knowledge, continues unabated. Recent attempts to stratify evidence into hierarchies based on 'levels' of sources and perceptions of quality have intensified the controversy pertaining to the relative merits of experimentation versus observation in the domain of modern therapeutics. The Scottish Intercollegiate Guideline Network (SIGN) is a typical example of a hierarchy of evidence [1]. All hierarchies place RCTs at the pinnacle, with observational studies languishing in the lower regions, and 'expert opinion' at the bottom. Hierarchies of evidence are now widely regarded as reliable measures of relative 'strength' of evidence in therapeutics, and used -particularly by committees that develop guidelines -to rank therapeutic interventions' merit, based on their perceived robustness. There is no gainsaying of course that popular acceptance of EBM has transformed medical practice and research preponderantly for the better, but the widespread and mechanical use of hierarchies of evidence has also raised many questions [2]. The findings of a single RCT or a systematic review of several will give evidence about the efficacy of an intervention (ie. 'the particular treatment has worked somewhere'), very often without supplying testimony regarding its clinical effectiveness in actual practice (ie. 'the treatment works extensively'), or its efficiency (ie. 'is it worth it?') [3,4,5].Most RCTs test efficacy with carefully selected patients, numerous exclusion criteria, absence of co-morbidities, intensely supervised treatment, monitored patient compliance and careful follow up -ideal conditions rarely available in actual clinical practice in which effectiveness and efficiency are important considerations [3,5,6]. RCT evidence is often not generalisable to certain groups of people, individuals, or different settings. Often RCT evidence also fades with time. To choose one example from the many available, older antipsychotic medications have been shown in large well-designed trials to be as effective as the newer ones (eg. olanzepine, risperidone etc.), and cost much less, alas! after widespread prescription of the newer drugs had made fortunes for their manufacturers [2].Among the large number of distinguished clinicians and scientists who have expressed serious misgivings about such hierarchies of evidenc...

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The effect of a herbal formulation on the incidence and severity of upper respiratory symptoms in healthy volunteers: an open-label, randomised controlled clinical trial

Cited by 4 publications

References 17 publications

Immunomodulatory Activity of a Traditional Sri Lankan Concoction of Coriandrum sativum L. and Coscinium fenestratum G.

Immunomodulatory Activity of a Traditional Sri Lankan Concoction of Coriandrum sativum L. and Coscinium fenestratum G.

Increased expression of co-stimulatory molecules and enhancement of the IgG response in rats orally administered with a polyherbal formulation

Clinical research with traditional herbal medicines

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