Kaloba: 30 Tablets

Product Information

In very rare cases (≤ 1/10,000), serious hypersensitivity reactions with swelling of the face, dyspnoea and drop in blood pressure may occur. Dosage: oral drops can be taken directly from a spoon or mixed with half a glass of water. The entire contents of the glass should be drunk straight away Roth M, Fang L, Stolz D, Tamm M. Pelargonium sidoides radix extract EPs 7630 reduces rhinovirus infection through modulation of viral binding proteins on human bronchial epithelial cells. PLoS One. 2019;14(2):e0210702.

In single cases, signs indicating disturbances of liver function have been reported after intake of Kaloba; the causal relationship between this effect and the use of the product has not been demonstrated. In the patient information leaflet, the patient is advised to consult a doctor immediately if his or her condition does not improve within one week, in case of fever lasting for several days or in case of shortness of breath or blood in the sputum. If you take more than the recommended dose, speak to your doctor, pharmacist or healthcare practitioner and take this leaflet with you. If you forget to take this product Kaloba is a traditional herbal medicinal product used to relieve the symptoms of upper respiratory tract infections such as the common cold, sore throats and coughs exclusively based on long standing use as a traditional remedy. Bhopal RS. The inter-relationship of folk, traditional and Western medicine within an Asian community in Britain. Soc Sci Med. 1986;22(1):99–105.

Familiarization: repeated readings of transcripts and listening to recordings assisted familiarisation with the data, identification of initial codes and interesting pieces of data Round, reddish-brown, smooth surface film coating without ruptures. 4 Clinical particulars 4.1 Therapeutic indications Of the 134 randomised patients, 82 were allocated to liquid (Kaloba® [ n = 42] or placebo [ n = 40]) and 52 to tablets (Kaloba® [ n = 26] or placebo [n = 26]). During the study period, three patients chose to withdraw – two from the liquid Kaloba® group, one from the liquid placebo group. One patient in the Kaloba® tablet group died due to reasons unrelated to the trial. After completing the trial, four patients were found to have been ineligible because they were women of reproductive age who were using a contraceptive which was not included in the list of the “most effective” contraceptives specified in the protocol. None of these were or subsequently became pregnant during the trial or experienced any adverse events. As the details of their contraception were only confirmed after they had completed the trial, their data is included in the analyses below, as were the data of all the withdrawn patients. The CONSORT diagram is given in Fig. 1. film-coated tablet contains 20 mg of extract (as dry extract) from the roots of Pelargonium sidoides DC (1 : 8 – 10) (EPs® 7630) Extraction solvent 11% ethanol (w/w).

Consult a doctor immediately if your condition worsens, or does not improve within one week, in case of fever lasting for several days or in case of shortness of breath or blood in the sputum. Little P, Moore M, Kelly J, Williamson I, Leydon G, McDermott L, et al. Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial. BMJ: British Medical Journal. 2013;347:f6041.

How to take this product

Adults and children 12+ should take one tablet three times a day (morning, midday, evening). Tablets should be swallowed whole with a little water. The tablets should not be chewed. We explored several possible outcome measures for clinical effectiveness (Table 3). “Duration of symptoms rated as moderately bad or worse” was used in the largest clinical trial of treatment for acute bronchitis [ 6]. The “last day” definitions allow for the possibility that the illness may fluctuate in severity over the 28-day period and the “first day” definitions do not. Therefore, the last day will tend to be later than or equal to the first day. “Proportion of patients with symptom resolution at day 7” was used in the Cochrane review [ 30]. Statistical methods Like all medicines, this product can have side-effects, although not everybody gets them. They are listed below. film-coated tablet contains 20 mg of extract (as dry extract) from the roots of Pelargonium sidoides DC (1 : 8 - 10) (EPs® 7630) Extraction solvent 11% ethanol (w/w). The liquid herbal medicinal product used in the study (Kaloba® manufactured by Dr. Willmar Schwabe GmbH & Co. KG, Germany) is tested and released compliant with drug GMP and the European Pharmacopoeia according to written, authorized and validated analytical procedures with respect to identity, content (ethanol, glycerin, extract; HPLC) and microbiological quality. The film-coated tablets are tested with the same methods, adapted to the respective dosage form with respect to extract content (HPLC), uniformity, disintegration and microbiological purity. The respective placebo preparation is tested with the same procedures, except for herbal drug content (i.e. absence of active ingredient) and in addition for visual appearance in comparison to the batch of herbal drug product used as medication. The quality testing is performed by the Quality Control laboratory of Dr. Willmar Schwabe GmbH & Co. KG, Germany by a laboratory technician with extensive long-term experience in the testing of herbal medicinal products. Personnel manufacturing or performing quality tests on investigational medicinal products including placebo preparations have been specifically skilled and trained in this field.

MLW: Conceptualisation, funding acquisition, investigation, methodology, formal analysis, supervision, writing – original draft, review and editing. CS: investigation, methodology, project administration, resources, supervision, validation, visualisation, writing – review and editing. SW: Formal analysis, writing – review and editing. BLS: Conceptualisation, Formal analysis, methodology, software, visualisation, writing – original draft, review and editing. DS: Investigation, project administration, formal analysis, writing – review and editing. AW: Conceptualisation, Methodology, software, Formal analysis. AM: project administration, investigation. EW: Data curation. SZ: Formal analysis (health economics), writing – original draft, review and editing. GY: Formal analysis (health economics), writing – review and editing. FW: Funding acquisition, supervision, writing – review and editing. RY: investigation, writing – review and editing. JB: PPI contributor, conceptualisation, writing – review and editing. MB: PPI contributor, conceptualisation, writing – review and editing. GG: Conceptualisation, methodology, supervision, writing – review and editing. GL: methodology, supervision, writing – review and editing. PL: Conceptualisation, methodology, writing – review and editing. CB: Conceptualisation, methodology, writing – review and editing. ADH: Conceptualisation, methodology, writing – review and editing. MM: Conceptualisation, Funding acquisition, methodology, project administration, supervision, writing – review and editing. The author(s) read and approved the final manuscript. Corresponding author Of the 127 eligible patients not randomised, in 69 cases this was because the patient declined, and 51 of these gave a reason. Most frequent were concerns about the medication (21/51 patients: 5 didn’t want a placebo; 5 were concerned about potential side-effects; 4 didn’t want to take more medicines; 2 didn’t want a herbal medicine; 2 did not want the liquid preparation; 1 did not want the tablets; 2 wanted antibiotics). Second most frequent (12/51) were patients who were too busy to participate or had personal circumstances which would make it difficult (planned holiday, unwell family member). Nine patients felt either that they were too unwell to take part [ 6] or that they were improving and didn’t need to take anything [ 2] or that taking part would make them too anxious [ 1]. Three patients stated that they just didn’t want to be involved in research. Five patients specifically mentioned that they wouldn’t be good at completing the diary and one would have had to travel to another branch surgery of his GP practice to be recruited. Spurling GKP, Del Mar CB, Dooley L, Foxlee R, Farley R. Delayed antibiotic prescriptions for respiratory infections. Cochrane Database Syst Rev. 2017;9. Whitehead A, Simpson C, Willcox M, Webley F, Hay AD, Butler C, et al. HATRIC: a study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of acute cough due to lower respiratory tract infection in adults—study protocol for a double blind, placebo-controlled randomised feasibility trial. Pilot and Feasibility Studies. 2019;5(1):98. 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.Brendler T, van Wyk BE. A historical, scientific and commercial perspective on the medicinal use of Pelargonium sidoides (Geraniaceae). J Ethnopharmacol. 2008;119(3):420–33. 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). Conrad A, Jung I, Tioua D, Lallemand C, Carrapatoso F, Engels I, et al. Extract of Pelargonium sidoides (EPs 7630) inhibits the interactions of group A-streptococci and host epithelia in vitro. Phytomedicine. 2007;14(Suppl 6):52–9.