Chewable cough tablets with improved palatability: A comparative phase II clinical trial.

Cough is the common disease condition which affects patients of every age. Numerous OTC medications available in community pharmacies however no antiviral treatment and even antibiotics has been shown to be effective without pre-existing lung infection. The treatment approach of medicinal herbs has been recognized for many decades and even longer for the treatment and prevention of cough. The aim of this study was to evaluate the safety and efficacy of Mukalbion poly herbal chewable tablets for the treatment of cough with improved palatability against a marketed brand (Poly herbal). For the formulation development of test group, the herbs were supplied by the Procurement department of Herbion Pakistan Pvt. Ltd. Althea officinalis (roots), Hedera helix (leaves) and Sisymbrium irio (seeds) were used for the manufacturing of Mukalbion (poly herbal, test group) chewable tablet. The comparative control clinical trial was carried out during a time frame of 07 months with sample size of 70 patients as per epidemiological software for sample size and each group contained 35 (±5) patients. Chewable tablets were administered and evaluated for effectiveness after 15 days of treatment. The data were collected by the patients through clinical trial questionnaire. The validated quality of life questionnaire (LCQ) was also used for assessment. The results were analyzed by applying paired sample T test by using IBM SPSS version 20.00. The p value was <0.005 at 95% confidence interval for cough variables including cough bouts, viscosity of sputum, chest congestion, sore throat and shortness of breath. The LCQ cough scale score was higher in test group as compared to control group. The test group also showed well tolerated in term of palatability. None of the patient claimed any of the side effects and no compliance were observed against the marketed brand.

The evaluation ofefficacy and safety of Cough (EMA) granules used for upper respiratory disorders.

Ivy leaf is used for the treatment of respiratory diseases with the intensive mucus formation, respiratory infections, and irritating cough coming from the common cold. Conferring to clinical trials, the efficacy, and tolerability of ivy leaf is good. The main compounds accountable for biological activity are triterpene and saponins. Ivy leaves show convulsive/antispasmodic, anti-inflammatory, antimicrobial, analgesic, anthelmintic and anti-thrombin activity. Not only ivy but also marshmallow and mustard seeds are used for these indications. This study was conducted to evaluate the efficacy and safety of Cough (EMA; European Medicines Agency) granules used for upper respiratory disorders. This clinical trial was conducted on 150 patients, out of which 75received the Cough (EMA) granules and 75received the placebo. The age range of patients was 3 years to above 15 years. The sample paired t-test was applied to evaluate the significant level. Cough (EMA) granules were found effective in the treatment of cough, cold, and flu symptoms. The new treatment Cough (EMA) granules were safe and well tolerated in patient at given specific age group. The study recommends that Cough (EMA) granules can be used effectively in the treatment of upper respiratory tract infection.

Evaluation of in vitro antioxidant capacity and reducing potential of polyherbal Coded capsules Arthitec 1 and Arthitec 2.

Free radicals are partially reduced form of metabolites of Nitrogen and Oxygen. These are highly reactive and potentially toxic compounds which are contributing factors in different chronic disease. The present study was aimed to determine antioxidant capability and reducing ability of coded polyherbal capsules (Arthitec 1 & Arthitec 2). DPPH (2,2'-diphenyl-1-picryl hydrazyl) assay is most commonly used method for gauging antioxidant capability of natural compounds. In this assay DPPH act as stable free radical which react with an antioxidant. For measuring reducing ability suspected antioxidant react with ferric tripyridyltriazine (Fe3± TPTZ) complex and convert ferric into ferrous. Results are evident that both capsule formulations Arthitec 1 & Arthitec 2 have promising antioxidant activity and reducing potential. Antioxidant potential of both coded capsules with varied concentrations (10, 50 and 100 µg/ml) were compared and in both cases scavenging activity and as well as reducing ability raised in a dose dependent manner just like standard Butylated hydroxyanisole (BHA).

To evaluate the efficacy and safety of CartiNovex plus tablet in osteoarthritis and rheumatoid arthritis.

Interminable arthritis issue, for example, osteoarthritis (OA) and rheumatoid arthritis (RA) have in like manner an upsurge of aggravation, and oxidative anxiety, bringing about dynamic histological modifications and incapacitating indications. As of now utilized allopathic prescription (extending from painkiller executioners to natural operators) is intense, yet regularly connected with genuine, even dangerous symptoms. Utilized for centuries in customary herbalism, restorative plants are a promising option, with bring down rate of unfavorable occasions and productivity every now and again tantamount with that of traditional medications. In any case, their instrument of activity is as a rule smooth and additionally indeterminate. Despite the fact that a large number of them have been demonstrated powerful in ponders done in vitro or on creature models, there is a shortage of human clinical proof. This clinical trial was conducted at Liaquat National Hospital, Karachi, Pakistan. This was a single blind, placebo control phase II clinical trial. Total 200 patients were enrolled in the study, in which 110 received the CartiNovex plus tablet and 90 received the placebo. The age range of patients was 40 years to above 70 years. The sample paired t-test was applied to evaluate the significant level. Different parameters like pain on sitting or lying, morning stiffness, pain on walking, stiffness in sitting, lying or resting later in the day, getting on/off toilet, light domestic duties (such as tidying room, dusting, cooking), WOMAC score % were tested for both group i.e. CartiNovex plus group and placebo group in all parameters CartiNovex plus show significant improvement in all parameters. CartiNovex plus tablet was very effective in the management of OA and RA. The CartiNovex plus tablet was safe and well tolerated in all patients and side effects are non-significant.

A randomized, control and comparative study of polyherbal formulation use for Malaria (Plasmodium falciparum).

Plasmodium falciparum is the most well-known reason for extreme and life-debilitating malaria. Falciparum malaria causes more than 1 million deaths annually. Malaria remains a noteworthy reason for major morbidity and mortality in the tropics, with Plasmodium falciparum accountable for the mainstream of the disease weight and Plasmodium vivax being the geologically greatest broadly dispersed cause of malaria. The controlling of severe malaria comprises quick direction of suitable parenteral anti-malarial agents and initial acknowledgement and treatment of the complications. This clinical trial was piloted in 100 patients, in which 50 received the test drug (Malarina) and 50 received the control drug (Quinine Bisulphate). The age range of patients was 12 years to above 50 years. The sample paired t-test was applied to evaluate the significant level. Malarina was very effective in treating malaria sign and symptoms. The new treatment Malarina was safe and well tolerated in all patients.

Comparison of Anti BPH capsule (herbal) and Terazosin HCl in the treatment of benign prostate hyperplasia.

Benign prostatic hyperplasia (BPH) is a disease of senile age, usually occurring> 60 years of age. BPH is a disease that involves cell proliferation of the prostate. Pathological hyperplasia affects the elements of the glandular and connective tissue of the prostate. This study is designed to scrutinize the efficacy and tolerability of herbal drug Anti BPH capsule for the management of benign prostate hyperplasia (BPH), in this study we select the 100 patients in which 50 received the Anti BPH capsule and 50 received the Terazosin HCl. We use the American Urological Association BPH Symptom Score Index Questionnaire to measure the quality of life of the patients. We compare the before treatment and after treatment results for each symptom. We record the following symptoms, incomplete emptying of bladder, Frequency, Intermittency, Urgency, Weak stream, Straining, Nocturia and weight of prostate gland by USG. We compare the both drug by using paired sample t-test. The level of significance of incomplete emptying of bladder before treatment and after treatment is 0.013 in test group and 0.032 in control group. Similarly the level of significance of Frequency before treatment and after treatment in test groups in, intermittency, Urgency, Weak stream, staining, Nocturia and mean weight of prostate gland are 0.007, 0.015, 0.044, 0.012, 0.017, 0.004 and 0.020; where as in control group afford as 0.031, 0.044, 0.044, 0.032, 0.024, 0.009 and 0.035 respectively. The herbal drug Anti BPH capsule is more effective in the treatment of BPH than Allopathic medicine Terazosin HCl.

To evaluate the efficacy and safety of CofNovex plus (EMA) syrup.

The cough and cold are very widespread conditions and a common purpose for advice in general practice. Utmost often the sign and symptoms of cough are produced by acute viral airway infection and the course is frequently benign. But it can be converted into bacterial super-infection and can cause acute bronchitis. Herbal medicines are used to treat symptoms of the cough and cold, and among these medicines Ivy leaf is used to treat mucous discharge and irritation in throat due to the cough and cold. In addition to synthetic substances such as acetylcysteine, carbocisteins, ambroxol and bromhexine, herbal medicines contain saponins, which are used in these indications. Not just Ivy, but also the marshmallow and mustard seeds used for these indications. This clinical trial was conducted in 220 patients, in which 110 receive the CofNovex plus European Medicines Agency (EMA) syrup and 110 receive the placebo. The age range of patients was 3 years to above 15 years. The sample paired t-test was applied to evaluate the significant level. CofNovex plus (EMA) syrup was very effective in treating cough and cold symptoms. The new treatment CofNovex plus (EMA) syrup was safe and well tolerated in patient at given specific age group.

Alternative treatment in Hepatitis B by using polyherbal formulation.

The hepatitis B is most prevalent diseases (along with morbidities) in Asian countries. This research study has been conducted to provide an alternative treatment which is safe, effective and cost-effective to comprehend relations of disease, symptoms, patients response and the clinical response via better management of hepatitis B. The goal of this research is to evaluate efficacy and safety of herbal medicine as compared to allopathic medicine in patients suffering from hepatitis B. This was a single blind, randomized controlled clinical trial conducted at Shifa-ul-Mulk Memorial Hospital Hamdard University, Karachi and Dar ul Shifa Unani Dawakhana Karachi, Pakistan. The patients of both genders ranging from 25 to 50 years with symptoms and diagnosed for hepatitis B that fulfilled the criteria for membership, and consented for participation were registered. Ethical committee clearance and permission was obtained from the concerned committee at Faculty of Eastern Medicine, Hamdard University, Karachi, Pakistan. No significant difference was identified after treatment and it was found that the efficacy of Alpha (Control drug) is same as Safoof akseer e jigar (Test drug). The data offered support to the null hypothesis and therefore research hypothesis was rejected. According to the statistical analysis by chi square, hepatitis B was recorded as negative in 26 patients (57.77%) out of 45 patients by the use of Interferon Alpha (control therapy) and in 27 patients (64.28%) out of 42 patients by the use of Safoof akseer e jigar (test drug). Comparison of the data recorded of the patients was determined as both drugs showed significant improvement and p value>0.05. The efficacy response is equal in both drugs while test drug showed more safety response. It is concluded that Safoof akseer e jigar possesses as effective a therapeutic value in treating hepatitis B as allopathic medicine.

Antipyretic potential of herbal coded formulation (Pyrexol).

The antipyretic effect of the aqueous extract of herbal coded formulation containing equal amount of Salix alba, Emblica officinalis, Glycyrrhiza glabra, Adhatoda vasica, Viola odorata, Thea sinensis, Veleriana officinalis, Foeniculum vulgare, Sisymbrium irrio and Achillea millefolium was investigated using the yeast induced pyrexia model in rabbits. Paracetamol was used as a control group. Rectal temperatures of all rabbits were recorded immediately before the administration of the extract or paracetamol and again at 1 hour, after this, temperature was noted at 1 hrs interval for 5 hrs using digital thermometer. At 240mg/kg dose the extract showed significant reduction in yeast-induced elevated temperature as compared with that of standard drug paracetamol (150mg/kg). It is concluded that herbal coded medicine at a dose of 240mg/kg has marked antipyretic activity in animal models and this strongly supports the ethno pharmacological uses of medicinal plants of this formulation.

An interquartile relationship between polyherbal extract based lozenges linkus a phase IV comparative randomised control trial.

The aim of the study is to determine the efficacy of polyherbal linkus with the other pharmaceutical marketed syrup having Acefyllin Piperazine, Diphenhydramine group and Aminophylline Diphenhydramine group on the basis of interquartile ranges on children. It was open label multi centric randomize control trial. The study was conducted on different private schools of East and West Malir, Karachi Pakistan with the special approval from the school's honors .informed consent and assents were taking before the enrollment of the study subjects .The study enrolled participants were 147 who evaluate on cough. Participants were divided into 3 interventional group according to the treatment regimen .One group of participant received Linkus Syrup however the 2nd group received Acefyllin Piperazine and 3rd group received Aminophylline Diphenhydramine group. The frequency of the cough on linkus syrup was considered to be achieved on the basis of interquartile relationship and impact has been observed on child and parent sleep and found significant (p <0.01).Poly herbal Linkus Syrup has the significant impact on cough frequency and associated problem on children and parent's sleep with minimum side effects (p<0.01) however the pharmacological treatments are considered to be more unwanted effects on human subjects.

Evaluation of in vitro urease and lipoxygenase inhibition activity of weight reducing tablets.

Enzyme inhibition is a significant part of research in pharmaceutical field in view of the fact that these studies have directed to the innovations of drugs having remarkable performance in diverse physiological conditions. The present study was aimed to assess urease and lipoxygenase inhibitory activity of weight reducing tablets. For evaluating the urease activity indophenol method was employed using Thiourea as the model urease inhibitor. The lipoxygenase inhibition was evaluated by measuring the hydroperoxides produced in lipoxygenation reaction using a purified lipoxygenase with lionoleic acid as substrate. When formulation of the weight reducing tablets was compared at various concentrations (50, 100 and 500µg/ml). The antiurease activity and lipoxygenase inhibition activity increased in a dose dependent manner. The formulations under test have an excellent antiurease and lipoxygenase inhibition potential and prospective to be used in the cure of a variety of complications associated with the production of urease and lipoxygenase enzymes.

Review: Comprehensive review on treatment of HIV.

HIV or AIDS is a major threat for humanity in the world especially in developing countries. The causative factor of the syndrome is HIV, which infects and destroys one of the cellular components of the immune system, the T cells, causing deficiency in the immunological surveillance and ultimately leading to AIDS. According to WHO, around 35 million people were living with HIV in 2013 and since the start of epidemic 39 million people have died due to AIDS. Center for disease control and prevention estimated in 2014 that 1,201,100 people aged 13 and above were suffering from HIV infection Worldwide. The most effective approach is the highly active antiretroviral therapy (HAART) containing the combined use of drugs having different mechanisms of action. However, complete eradication of HIV from the body does not occur by HAART, but it lead to long term toxicity occurs and emerges as drug resistant. Despite the recent development of various new antiretroviral compounds, there is still a need to develop need to search for new alternatives which are equally efficient and less expensive as compared to the contemporary treatment available. This review provides an overview and a summary of herbal medicines for HIV infection and summarized the efficacy and medicinal use of different plants used in the treatment of HIV infection. The objective of this review is to enlighten the recent advances in the exploration of medicinal plants used for treatment of HIV/AIDS.

Quantitative Determination of Catechin as Chemical Marker in Pediatric Polyherbal Syrup by HPLC/DAD.

Vivabon syrup is a balanced composition of dietary ingredients of phytopharmaceutical nature for maintaining the physique, vigor, vitality and balanced growth of children. The herbal ingredients of pediatric syrup are rich in bioflavonoid, proteins, vitamins, glycosides and trace elements. Vivabon is formulated with herbal drugs such as Phoenix sylvestris, Emblica officinalis, Withania somnifera, Centella asiatica, Amomum subulatum, Zingiber officinalis, Trigonella foenum-graecum, Centaurea behen and Piper longum Catechins are flavan-3-ols that are found widely in the medicinal herbs and are utilized for anti-inflammatory, cardio protective, hepato-protective, neural protection and other biological activities. In general, the dietary intake of flavonoids has been regarded traditionally as beneficial for body growth. Standardization of Vivabon syrup dosage form using HPLC/DAD has been developed for quantitative estimation of Catechin as a chemical marker. The method was validated as per ICH guidelines. Validation studies demonstrated that the developed HPLC method is quite distinct, reproducible as well as quick and fast. The relatively high recovery and low comparable standard deviation confirm the suitability of the developed method for the determination of Catechin in syrup.

Ways to manage hepatitis C without cirrhosis: Treatment by comparison of coded eastern medicine hepcinal with interferon alpha 2b and ribavirin.

Hepatitis C virus (HCV) infection is a serious and significant global health problem in the Pakistan and elsewhere. In majority of cases HCV infection remains asymptomatic but in advance cases it may progress to fibrosis of liver, shrinkage of liver cells or failure of liver. The hepatitis C may progress to cause liver cirrhosis that mostly develop in 20% of the affected patients in 20 years with an increased risk in male, alcoholic drink, immune-compromised and who acquire HCV infection after the age of 40 years. This was an open-label prospective study conducted on 66 clinically and immunologically diagnosed cases of HCV infection. In Hepcinal treated group, there were significant improvement in HCV associated symptoms compared to control group (p<0.05). While Interferon therapy resulted in significant improvement in serological response (55.88%) compared to Hepcinal treated patients (46.88%). It was concluded that Hepcinal has shown better clinical response but no significant serological response (p=0.3244) and it might be an alternative therapy to treat hepatitis C infection and to prevent its progression into chronic ailment.

The effects of new polyherbal Unani formulation AJMAL06 on serum creatinine level in chronic renal failure.

This study was conducted to evaluate the efficacy of Unani Ajmal06, an herbal formulation for management of chronic renal failure (CRF). The therapeutic evaluations of three different formulations such as Itrifal Kashneezi, Jawarsih Zarooni Sada medicines were conducted on number 35 CRF patients clinically diagnosed cases of chronic kidney failure. It was found that herbal coded Ajmal06 was effective for the treatment of CRF in 70% of the patients treated. SPSS tests on sign and symptoms indicated the efficacy of Ajmal06 in lowering serum creatinine level in 70% of patients of chronic renal failure. In clinical response of BUN exhibited 75% of patients improved where as in case of fatigue (70%), edema (90%), leg pain (76%) improved these types of conditions with significant p value.

Evaluation of antipyretic activity of some medicinal plants from Cholistan desert Pakistan.

Traditional herbal healers "Hakims" use various plants of the Cholistan desert, Pakistan for treating a number of infectious and non-infectious diseases. However, there has never been a scientific validation of these plant-based therapeutics. We compared the antipyretic effect of Echinops echinatus, Alhagi maurorum, Fagonia cretica, Cymbopogon jwarancusa and Panicum turgidum in animal model. These plants were used to reduce E.coli lysate induced pyrexia in rabbits. There were five groups of rabbits having five rabbits in each group. Among these five groups, three received various doses of experimental treatment, paracetamol was given to fourth group known as positive control. The fifth group of animals served as negative control and received no treatment. Ethanol extracts of Fagonia cretica (500 mg/kg), Panicum turgidum (500 mg/kg and 750 mg/kg), Alhagi maurorum (500 and 750 mg/kg), Cymbopogon jwarancusa (250 mg/kg) and Echinops echinatus (750 mg/kg) showed significant antipyretic effects when compared with controls and experimental counterparts. These results revealed that ethanol extracts of the plants evaluated in this study have dose dependent antipyretic activity. Further detailed screening of these plant species is recommended.

Alternative treatment for iron deficiency anemia: Irocbin versus Sherbat Faulad.

The wide spread reason of anemia is Iron deficiency in Pakistan and even worldwide. A clinical trial was undertaken to assess the efficacy of Irocbin formulation for the treatment of iron deficiency anemia as compared to Sherbat Faulad. The curative evaluations of these medicines were recorded in clinically and biochemically identified cases of iron deficiency anemia. The therapeutic evaluation of the different drugs both test and control drug were conducted on the bases of improvement in the subjective signs and symptoms, clinical observations and biochemical investigations at periodic intervals during the course of therapy. This data was collected in the period November 2010 to November 2012 and completed the clinical trials. According to the statistical analysis comparison of data recorded by patients concerning to different variables, showed significant results between test and control groups (p<0.05). By applying ANOVA test, the p values for multiple comparisons of the levels of improvement of Hemoglobin after treatment exhibited significant difference as compared Sherbat Faulad and Irocbin. The control drug Sherbat Faulad with only iron component improves Hemoglobin level and the sign and symptoms but associated with side adverse effects.

Efficacy of Gingocap as compared to pyridoxine in the treatment of nausea and vomiting during pregnancy.

Nausea and vomiting is the common problem disturbing almost 80% of the females in initial three months of conception and later sometime throughout pregnancy. To find out the efficacy and safety of herbal coded test drug Gingocap in comparison with the control drug Pyridoxine, a randomized clinical case control study was conducted at the OPD of Yusra Medical Centre, Karachi and Amir Habib Medical Center and Maternity Home, Karachi. After administration of test and control drug the frequency of nausea and vomiting was noted after every 2 weeks on 2nd, 4th, 6th and 8th weeks during 60 days of the course of study. The percentage of reduction of nausea and vomiting symptoms from the baseline in cases treated with test Gingocap compared to control drug Pyridoxine was recorded. Overall 35 and 30 patients were administered Gingocap and Pyridoxine between 6-16 weeks conception respectively. The data analyzed through T-test using SPSS version 18.0. It was concluded that Gingocap has the potential to relieve the symptoms of nausea and vomiting and exhibited no side effects and this drug was acceptable by maximum number of the patients.

Clinical study on the efficacy of Amoebex (coded herbal drug) compared with Metronidazole for the treatment of Amoebic dysentery.

Amoebiasisis an infectious disease, which originated with the single-celled parasitic protozoan Entamoeba histolytica. The parasitic amoeba infects the liver and intestine and may cause mild diarrhea and serious dysentery with bloody and mucoid stool. A study was conducted to evaluate the efficacy of Amoebex (400mg), a herbal formulation for the treatment of amoebiasis infections as compared to that of Metronidazole (400mg). The therapeutic evaluations of these medicines were carried out on 184 clinically diagnosed cases of the amoebiasis infection. Sample sizes of Ameobex for this study included a total of 93 patients and for Metronidazole a total of 91 were registered and treated. Comparison of the data recorded for the participants relating to sign and symptoms variables showed significant differences of efficacy between test and control groups (p<0.0357) and no side effects were at all recorded in test group. According to observation, there was a difference in the overall clinical success of both treatment groups, however, the efficacy of the test treated medication (Amoebex) was superior to that of Metronidazole as (p<0.03), and on the basis of the statistical analysis done by the chi square test, the null hypothesis was rejected. `It is clearly evident that Amoebex possesses therapeutic value for the treatment of amoebiasis associated symptoms but also the eradication rate of amoebiasis is superior by Amoebex as compared to that of Metronidazole (Control drug).

Review-Medicinal plants and management of Diabetes Mellitus: A review.

Diabetes is a metabolic disorder characterized by chronic hyperglycemia and associated with dysfunction and failure of various body organs. Alarming increase in prevalence rate has made this disorder a major health problem globally. The available treatment modalities are not sufficient to combat diabetes and associated complications. A number of medicinal plants have a significant antidiabetic potential against diabetes mellitus. We have listed the use of important medicinal herbs for the treatment and management of diabetes in this review.