Kaloba: 30 Tablets

Product Information

A detailed statistical analysis plan was developed prior to the analysis. All analyses were conducted using STATA version 15 [ 35]. We aimed to present descriptive feasibility data rather than to test hypotheses and patients were analysed as randomised. Health economic methods This product is a traditional herbal medicinal product containing Pelargonium sidoides DC root extract. Each film-coated tablet of this product contains 20 mg of a dry extract from the roots of Pelargonium sidoides DC. We recruited patients from 20 GP practices in southern England. We included adults aged 18 years and over, presenting to their GP with an acute cough (≤21 days’ duration) as their main symptom, and with symptoms localising to the lower tract (e.g. sputum, chest pain, dyspnoea, wheeze). This illness definition has been used in other studies in this population [ 6, 34]. We excluded patients with suspected pneumonia on the basis of focal chest signs (focal crepitations, bronchial breathing) and systemic features (severe breathlessness, high fever, vomiting, severe diarrhoea), patients with serious illness who required hospital admission, exacerbations of COPD, serious comorbidities, and pregnant women (or at risk of pregnancy – defined as any woman of reproductive age not using the combined oral contraceptive pill, a hormonal intrauterine device, a hormonal contraceptive injection, or a subcutaneous hormonal implant).

If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. 4.3 ContraindicationsBao Y, Gao Y, Koch E, Pan X, Jin Y, Cui X. Evaluation of pharmacodynamic activities of EPs(R) 7630, a special extract from roots of Pelargonium sidoides, in animals models of cough, secretolytic activity and acute bronchitis. Phytomedicine. 2015;22(4):504–9. In addition to the trial treatment, GPs were allowed to select the clinically appropriate prescribing strategy as per practice policy, no antibiotics or to prescribe antibiotics, either to be taken immediately, or as a “delayed” prescription. Outcomes Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Serious hypersensitivity reactions with swelling of the face, breathlessness and decrease in blood pressure. However, due to the potential effect of Kaloba on coagulation parameters, this product may enhance the effect of coagulation-inhibiting drugs such as warfarin and should not be taken concomitantly with these drugs. (see section 4.3). 4.6 Pregnancy and lactation Herbal medicine is another option for relieving symptoms and so reducing inappropriate use of antibiotics [ 12]. Qualitative research has shown that herbal medicine is widely used and accepted as a viable option for treatment of mild respiratory infections, especially by ethnic minorities, but very few studies have included white Caucasian adults [ 13, 14, 15, 16]. Many patients feel that they need trustworthy advice on whether to use alternative treatments, which to use, and when [ 17]. Our results suggest that progression to a full randomised phase III trial is feasible. The feasibility trial has identified some key modifications which will be needed. It would be easier to choose only one formulation to test (liquid or tablet). Although most patients reported that they would prefer tablets, the Cochrane review [ 30] suggested that the liquid may be more effective. If the liquid is to be taken into a full trial, a more convenient dosage method may need to be provided as many patients struggled accurately to count 30 drops per dose. If a full study uses both liquid and tablet preparations, we would need to adapt the design to prevent imbalance in the antibiotic use. This could be achieved by individual randomisation (tablet/liquid/active/placebo) or through stratification of practices according to prior antibiotic prescribing history. Kaloba is one of the few herbal cold remedies on the market that contains Pelargonium. Pelargonium sidoides is a member of the geranium family, which has long stalked leaves that are mildly aromatic, heart shaped and velvety.

1 Name of the medicinal product

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. 4.7 Effects on ability to drive and use machine Signs indicating changes in liver function have been reported after taking Kaloba; however, the causal relationship between these effects and the use of the product has not been demonstrated. Kumar R, Lorenc A, Robinson N, Blair M. Parents' and primary healthcare practitioners' perspectives on the safety of honey and other traditional paediatric healthcare approaches. Child: Care, Health & Development. 2011;37(5):734–43.