Breakthrough Natural Eczema Treatment: Takzema Tablets Showed Positive Results in 88% of Eczema Patients
Biogetica is pleased to announce latest clinical trials that have shown dramatic results (88% positive) using advanced natural herbs for eczema relief.
Culver City, CA, November 07, 2009 --(PR.com)-- Biogetica Offers treatments for Eczema that includes Takzema Tablets and Oinments. These Takzema Tablets showed positive results in 88% of Eczema patients. The Clinical Study of these Takzema Tablets is given below:
Evaluation of Takzema Tablets and Ointment (Multi-Ingredient Ayurvedic Formulation) in the Management of Eczema
Authors
D.G. Saple, S. Medhekar - G.T.Hospital & Grant Medical College, Mumbai, India.
Milind Patil - Medical Advisor, Charak Pharmaceuticals Pvt. Ltd., Mumbai.
Eczematous diseases affect more than 10% of the general population and 15-25% of all dermatological patients suffer from eczema.
The current management of eczema revolves around the use of topical and systemic steroids, antihistamines and soothing and moisturizing agents. Use of steroids (topical and systemic) is fraught with side-effects. Antihistamines have practically very little to offer in eczema.
Therefore, there is a need to introduce treatment approaches that are effective and do not produce undesirable side-effects. Takzema (tablets and ointment) is one such Ayurvedic formulation that contains ingredients such as Rubia cordifolia, Tinospora cordifolia, Berberis aristata, Azadirachta indica, Swertia chirata and others.
Materials And Methods
This was an open labeled study to assess the efficacy and safety of Takzema tablets and ointment in 50 sequential patients of either sex between 18 to 55 years of age suffering from mild to moderate eczema.
Ambulatory patients of both sexes freshly diagnosed as well as pre-existing patients (with a wash out interval of 2 weeks if on treatment) with eczema and clinical diagnosis of eczema in any location of the body were included. The patients had clinical symptoms associated with eczema such as itching, oozing and desquamation.
The exclusion criteria included patients with infected lesions, history of ischemic heart disease, pregnant and lactating women; patients receiving corticosteroid treatment; patients with history of gastritis, peptic ulcer, bleeding ulcers; hiv, hbv and known allergic reaction to systemic/topical study drugs. Patients were required to be administered other concomitant medications such as anti-hypertensive and oral hypoglycemic agents at stable dosage for at least 1 month.
A thorough physical examination and necessary laboratory investigations, which included hemoglobin, cbc count, esr, liver and kidney function tests were carried out before drug administration and after completion of treatment.
After confirmation of diagnosis, patients meeting the inclusion and exclusion criteria were included in the study and received 2 Takzema tablets bid for 8 weeks and Takzema Ointment to be applied over the affected area/s thrice daily as a thin film and rubbed in gently and completely for 8 weeks.
Safety and efficacy evaluation of patients’ clinical response to treatment was monitored from screening (day 0) till the end of therapy (end of 8 weeks). All data were carefully entered in the Case Record Form provided. Side effects were closely monitored in all patients. All adverse events were recorded by the investigator, and rated for severity and relationship to the study medication. However, significant exacerbations or worsening of pre-existing conditions were recorded. Drop out cases with reasons (non-compliance, side-effects or others) were noted. Any abnormal laboratory values were also noted.
The efficacy was evaluated on the basis of parameters of modified eczema area sensitivity index (easi), physicians and patient’s global evaluation at follow-up visits.
The investigator global assessment (iga) on efficacy and tolerability was performed. Patient’s global assessment on the efficacy and tolerability of treatment was similarly performed.
Treatment with the Takzema tablets and Takzema ointment was well tolerated and did not lead to any abnormalities in the laboratory investigations as compared to the baseline values.
At the end of 2nd, 4th and 8th week, mean score of erythema had a reduction of 12.7%, 37% and 55%, respectively from baseline. At the end of 2nd, 4th and 8th week, mean score of oozing had a fall of 6.3%, 17.7% and 17.7%, respectively from baseline. At the end of 2nd, 4th and 8th week, mean score of indurations had a fall of 4%, 19.33% and 19.33%, respectively. At the end of 2nd, 4th and 8th week mean score of pruritus had a fall of 6%, 31.33% and 44% respectively from baseline.
At the end of 8 weeks, intensity of individual parameters like erythema and pruritus showed a statistically significant improvement from the baseline (P<0.50), while oozing and indurations also reduced.
The global assessment of response by physicians showed that 30% of patients showed a good improvement while another 52% showed fair improvement in their condition by the end of 8 weeks of treatment. Similarly, the patients’ global assessment indicated fair to good response in 88% of the patients at the end of treatment.
In conclusion, this study confirms the efficacy and safety of Takzema Tablets and Takzema Ointment in Indian patients with mild to moderate eczema.
###
Evaluation of Takzema Tablets and Ointment (Multi-Ingredient Ayurvedic Formulation) in the Management of Eczema
Authors
D.G. Saple, S. Medhekar - G.T.Hospital & Grant Medical College, Mumbai, India.
Milind Patil - Medical Advisor, Charak Pharmaceuticals Pvt. Ltd., Mumbai.
Eczematous diseases affect more than 10% of the general population and 15-25% of all dermatological patients suffer from eczema.
The current management of eczema revolves around the use of topical and systemic steroids, antihistamines and soothing and moisturizing agents. Use of steroids (topical and systemic) is fraught with side-effects. Antihistamines have practically very little to offer in eczema.
Therefore, there is a need to introduce treatment approaches that are effective and do not produce undesirable side-effects. Takzema (tablets and ointment) is one such Ayurvedic formulation that contains ingredients such as Rubia cordifolia, Tinospora cordifolia, Berberis aristata, Azadirachta indica, Swertia chirata and others.
Materials And Methods
This was an open labeled study to assess the efficacy and safety of Takzema tablets and ointment in 50 sequential patients of either sex between 18 to 55 years of age suffering from mild to moderate eczema.
Ambulatory patients of both sexes freshly diagnosed as well as pre-existing patients (with a wash out interval of 2 weeks if on treatment) with eczema and clinical diagnosis of eczema in any location of the body were included. The patients had clinical symptoms associated with eczema such as itching, oozing and desquamation.
The exclusion criteria included patients with infected lesions, history of ischemic heart disease, pregnant and lactating women; patients receiving corticosteroid treatment; patients with history of gastritis, peptic ulcer, bleeding ulcers; hiv, hbv and known allergic reaction to systemic/topical study drugs. Patients were required to be administered other concomitant medications such as anti-hypertensive and oral hypoglycemic agents at stable dosage for at least 1 month.
A thorough physical examination and necessary laboratory investigations, which included hemoglobin, cbc count, esr, liver and kidney function tests were carried out before drug administration and after completion of treatment.
After confirmation of diagnosis, patients meeting the inclusion and exclusion criteria were included in the study and received 2 Takzema tablets bid for 8 weeks and Takzema Ointment to be applied over the affected area/s thrice daily as a thin film and rubbed in gently and completely for 8 weeks.
Safety and efficacy evaluation of patients’ clinical response to treatment was monitored from screening (day 0) till the end of therapy (end of 8 weeks). All data were carefully entered in the Case Record Form provided. Side effects were closely monitored in all patients. All adverse events were recorded by the investigator, and rated for severity and relationship to the study medication. However, significant exacerbations or worsening of pre-existing conditions were recorded. Drop out cases with reasons (non-compliance, side-effects or others) were noted. Any abnormal laboratory values were also noted.
The efficacy was evaluated on the basis of parameters of modified eczema area sensitivity index (easi), physicians and patient’s global evaluation at follow-up visits.
The investigator global assessment (iga) on efficacy and tolerability was performed. Patient’s global assessment on the efficacy and tolerability of treatment was similarly performed.
Treatment with the Takzema tablets and Takzema ointment was well tolerated and did not lead to any abnormalities in the laboratory investigations as compared to the baseline values.
At the end of 2nd, 4th and 8th week, mean score of erythema had a reduction of 12.7%, 37% and 55%, respectively from baseline. At the end of 2nd, 4th and 8th week, mean score of oozing had a fall of 6.3%, 17.7% and 17.7%, respectively from baseline. At the end of 2nd, 4th and 8th week, mean score of indurations had a fall of 4%, 19.33% and 19.33%, respectively. At the end of 2nd, 4th and 8th week mean score of pruritus had a fall of 6%, 31.33% and 44% respectively from baseline.
At the end of 8 weeks, intensity of individual parameters like erythema and pruritus showed a statistically significant improvement from the baseline (P<0.50), while oozing and indurations also reduced.
The global assessment of response by physicians showed that 30% of patients showed a good improvement while another 52% showed fair improvement in their condition by the end of 8 weeks of treatment. Similarly, the patients’ global assessment indicated fair to good response in 88% of the patients at the end of treatment.
In conclusion, this study confirms the efficacy and safety of Takzema Tablets and Takzema Ointment in Indian patients with mild to moderate eczema.
###
Contact
Biogetica
Dhaval Modi
1800 592 0304
www.biogetica.com
Dhaval Modi
1800 592 0304
www.biogetica.com
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